Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT03857620
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-21
First Post:
2019-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Use of a Pre-Surgical Toolkit in Improving Surgical Care and Outcomes in Older Participants With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002277', 'term': 'Carcinoma'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017410', 'term': 'Practice Guidelines as Topic'}], 'ancestors': [{'id': 'D017408', 'term': 'Guidelines as Topic'}, {'id': 'D011785', 'term': 'Quality Assurance, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gchang@mdanderson.org', 'phone': '713-563-1875', 'title': 'George J. Chang, MD, MS', 'organization': 'University of Texas MD Anderson Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Duration of the study, up to 1 year', 'description': "The exclusion to CTEP-AERS Expedited Reporting Requirements was outlined in the study Protocol Section 9.3.3. The adverse events were assessed only between initial surgical consultation (baseline) and on the day of surgery and additional reporting per Section 9.3.3. The study intervention refers to the administration of the OPTI-Surg toolkit (Edmonton Frail Scale and the follow-up recommendations) and not the surgery itself, which is why this trial doesn't have a typical collection of AEs.", 'eventGroups': [{'id': 'EG000', 'title': 'Arm I (Usual Care)', 'description': 'Healthcare providers/institutions perform usual care', 'otherNumAtRisk': 94, 'deathsNumAtRisk': 94, 'otherNumAffected': 5, 'seriousNumAtRisk': 94, 'deathsNumAffected': 4, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm II (OPTI-Surg Training and Materials)', 'description': 'Healthcare providers/institutions receive OPTI-Surg training and informational materials', 'otherNumAtRisk': 114, 'deathsNumAtRisk': 114, 'otherNumAffected': 16, 'seriousNumAtRisk': 114, 'deathsNumAffected': 5, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Arm III (OPTI-Surg Training and Materials, Coach)', 'description': 'Healthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach', 'otherNumAtRisk': 117, 'deathsNumAtRisk': 117, 'otherNumAffected': 13, 'seriousNumAtRisk': 117, 'deathsNumAffected': 7, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Arterial fibrilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Cardiac disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Chest pain - cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hearing impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Obstruction gastric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Pancreatic fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Gen disord and admin site conds-Oth spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Esophageal anastomotic leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Postoperative hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Cholesterol high', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hypernatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hypertriglyceridemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Obesity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Generalized muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Cognitive disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Renal and urinary disorders - Oth spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Sleep apnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Surgical and medical proced - Oth spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}], 'seriousEvents': [{'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Intestinal stoma leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Physical Function 8 Weeks Post-surgery as Measured by the Caloric Expenditure Scale Per Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Usual Care)', 'description': 'Healthcare providers/institutions perform usual care.'}, {'id': 'OG001', 'title': 'Arm II (OPTI-Surg Training and Materials)', 'description': 'Healthcare providers/institutions receive OPTI-Surg training and informational materials.'}, {'id': 'OG002', 'title': 'Arm III (OPTI-Surg Training and Materials, Coach)', 'description': 'Healthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.5', 'spread': '2.53', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '2.45', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '2.96', 'groupId': 'OG002'}]}]}, {'title': '8 weeks post-surgery', 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.94', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '2.26', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '1.76', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.53', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.85', 'ciUpperLimit': '0.45', 'groupDescription': 'Combined Arm II (OPTI-Surg) \\& Arm III (OPTI-Surg plus Coach) vs. Arm I (Usual Care)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed effects model (w/ Gaussian link) w/ random practice effect to account for clustering by site \\& bsl CHAMPS score as covariate'}, {'pValue': '0.84', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.67', 'ciUpperLimit': '0.81', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed effects model (w/ Gaussian link) w/ random practice effect to account for clustering by site \\& bsl CHAMPS score as covariate'}, {'pValue': '0.19', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.48', 'ciLowerLimit': '-1.21', 'ciUpperLimit': '0.26', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed effects model (w/ Gaussian link) w/ random practice effect to account for clustering by site \\& bsl CHAMPS score as covariate'}, {'pValue': '0.14', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '1.29', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed effects model (w/ Gaussian link) w/ random practice effect to account for clustering by site \\& bsl CHAMPS score as covariate'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks post surgery', 'description': 'The CHAMPS questionnaire includes 41 questions that measures frequency and duration of activities. The primary endpoint is the estimated Caloric Expenditure Per Week measure from the CHAMPS, which is calculated by weighting the duration variable of the 28 exercise-related activities using the corresponding metabolic equivalents (METs) value, then multiplying by 60 to convert METs/minute to METs/hour, then multiplying by participant weight in kg/200 to calculate the caloric expenditure/week score, and then summing the individual item caloric expenditure scores across all 28 items. This scale score was transformed into the unit of kcal. The minimum possible value of the scale is 0 and there is not a defined maximum possible value. Higher scores equate to more kilocalories burned per week, which is a better outcome in the context of this trial.', 'unitOfMeasure': 'kcal', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants who undergo major cancer surgery, consent to complete CHAMPS questionnaires, have a baseline CHAMPS score and have a CHAMPS score at 8 weeks post-surgery +/- 2 weeks.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Postoperative Complications (Clavien-Dindo Grades I-V)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Usual Care)', 'description': 'Healthcare providers/institutions perform usual care.'}, {'id': 'OG001', 'title': 'Arm II (OPTI-Surg Training and Materials)', 'description': 'Healthcare providers/institutions receive OPTI-Surg training and informational materials.'}, {'id': 'OG002', 'title': 'Arm III (OPTI-Surg Training and Materials, Coach)', 'description': 'Healthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.6', 'groupId': 'OG000'}, {'value': '44.8', 'groupId': 'OG001'}, {'value': '26.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.50', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.23', 'ciUpperLimit': '2.09', 'groupDescription': 'Combined Arm II (OPTI-Surg) \\& Arm III (OPTI-Surg plus Coach) vs. Arm I (Usual Care)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed effects model (with logit link function) with a random practice effect to account for clustering within practice'}, {'pValue': '0.21', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.46', 'ciLowerLimit': '0.13', 'ciUpperLimit': '1.62', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed effects model (with logit link function) with a random practice effect to account for clustering within practice'}, {'pValue': '0.96', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.30', 'ciUpperLimit': '3.54', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed effects model (with logit link function) with a random practice effect to account for clustering within practice'}, {'pValue': '0.19', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.45', 'ciLowerLimit': '0.13', 'ciUpperLimit': '1.54', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed effects model (with logit link function) with a random practice effect to account for clustering within practice'}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'Postoperative complications were assessed at 12 weeks following surgery using the Clavien-Dindo classification:\n\nGrade I: Any deviation from the normal postoperative course w/out the need for pharmacological treatment or surgical, endoscopic, and radiological interventions Grade II: Requiring pharmacological treatment w/ drug other than such allowed for Grade I complications Grade III: Requiring surgical, endoscopic or radiological intervention Grade IIIa: Intervention not under general anesthesia Grade IIIb: Intervention under general anesthesia Grave IV: Life-threatening complication Grade IVa: Single organ dysfunction Grade IVb: Multiorgan dysfunction Grave V: Death A generalized linear mixed model (with logit link function) with random practice effect to account for clustering within practice will be used to compare postoperative complications within 12 weeks of surgery between the combined OPTI-Surg no-coach \\& coach arms vs usual care followed by pairwise comparisons', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants who undergo major cancer surgery (no documentation of postoperative complications will be considered as not having any postoperative complications).'}, {'type': 'SECONDARY', 'title': 'Compliance Rate With Administration of Edmonton Frail Scale (EFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm II (OPTI-Surg Training and Materials)', 'description': 'Healthcare providers/institutions receive OPTI-Surg training and informational materials.'}, {'id': 'OG001', 'title': 'Arm III (OPTI-Surg Training and Materials, Coach)', 'description': 'Healthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach.'}], 'classes': [{'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day of surgical consult', 'description': 'EFS is a validated measure of frailty that identifies distinct frailty domains that are potential targets for additional pre-operative optimization. For frailty domains that score 1 or 2 points, optimization referrals will be recommended. Clinic or research staff at sites randomized to OPTI-Surg intervention arms will screen and identify eligible patients for administration of the EFS and provide printed surgery preparation materials. A generalized linear mixed model (with logit link function) with a random practice effect to account for clustering within practice will be used to compare compliance rate for screening between the no-coach and coach arms.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants from Arm II (OPTI-Surg) and Arm III (OPTI-Surg plus Coach) who undergo major cancer surgery who are evaluable for postoperative complications outcome. Notes: Generalized linear mixed model analysis not performed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I (Usual Care)', 'description': 'Healthcare providers/institutions perform usual care.'}, {'id': 'FG001', 'title': 'Arm II (OPTI-Surg Training and Materials)', 'description': 'Healthcare providers/institutions receive OPTI-Surg training and informational materials.'}, {'id': 'FG002', 'title': 'Arm III (OPTI-Surg Training and Materials, Coach)', 'description': 'Healthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '13', 'numSubjects': '94'}, {'groupId': 'FG001', 'numUnits': '14', 'numSubjects': '114'}, {'groupId': 'FG002', 'numUnits': '11', 'numSubjects': '117'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '10', 'numSubjects': '68'}, {'groupId': 'FG001', 'numUnits': '9', 'numSubjects': '83'}, {'groupId': 'FG002', 'numUnits': '10', 'numSubjects': '92'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '26'}, {'groupId': 'FG001', 'numUnits': '5', 'numSubjects': '31'}, {'groupId': 'FG002', 'numUnits': '1', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Disease progression or relapse after study registration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'No malignancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Patient withdrawal/refusal prior to surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Patient withdrawal/refusal after surgery performed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Surgery not performed due to worsening performance status/medical ineligibility', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Surgery not performed, patient decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Surgery not performed, other reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Worsening performance status after surgery performed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'typeUnitsAnalyzed': 'Sites', 'recruitmentDetails': 'Three-hundred and twenty-five participants (94 Arm I, 114 Arm II, 117 Arm III) were enrolled between April 2019 to September 2022 from 29 sites (10 Arm I, 9 Arm II, 10 Arm III). Recruitment was temporarily paused from March 25, 2020 to June 15, 2020 due to the COVID-19 pandemic. Data as of 3/15/2024 that was summarized for manuscript submission, is reported here.', 'preAssignmentDetails': 'This was a cluster-randomized trial at the practice level. Thirty sites with practice types of major abdominal (18 sites), thoracic (6 sites) or urologic (6 sites) were randomized initially in a 1:1:1 fashion to each arm. A total of 9 sites withdrew prior to accruing a patient due to inability to meet accrual expectations/had issues with resource allocation. Eight additional sites were randomized. A total of 29 sites remained with the study participation and accrued at least 1 patient.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}, {'value': '325', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I (Usual Care)', 'description': 'Healthcare providers/institutions perform usual care.'}, {'id': 'BG001', 'title': 'Arm II (OPTI-Surg Training and Materials)', 'description': 'Healthcare providers/institutions receive OPTI-Surg training and informational materials.'}, {'id': 'BG002', 'title': 'Arm III (OPTI-Surg Training and Materials, Coach)', 'description': 'Healthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '76.5', 'spread': '4.83', 'groupId': 'BG000'}, {'value': '75.6', 'spread': '4.73', 'groupId': 'BG001'}, {'value': '76.7', 'spread': '5.12', 'groupId': 'BG002'}, {'value': '76.3', 'spread': '4.91', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '148', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '177', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '263', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}, {'value': '325', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Weight', 'classes': [{'categories': [{'measurements': [{'value': '77.1', 'spread': '13.47', 'groupId': 'BG000'}, {'value': '81', 'spread': '18.68', 'groupId': 'BG001'}, {'value': '82.4', 'spread': '20.38', 'groupId': 'BG002'}, {'value': '80.4', 'spread': '18.06', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-16', 'size': 1474397, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2024-11-05T18:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 325}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2019-02-26', 'resultsFirstSubmitDate': '2024-11-06', 'studyFirstSubmitQcDate': '2019-02-26', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-31', 'studyFirstPostDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical Function 8 Weeks Post-surgery as Measured by the Caloric Expenditure Scale Per Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire', 'timeFrame': '8 weeks post surgery', 'description': 'The CHAMPS questionnaire includes 41 questions that measures frequency and duration of activities. The primary endpoint is the estimated Caloric Expenditure Per Week measure from the CHAMPS, which is calculated by weighting the duration variable of the 28 exercise-related activities using the corresponding metabolic equivalents (METs) value, then multiplying by 60 to convert METs/minute to METs/hour, then multiplying by participant weight in kg/200 to calculate the caloric expenditure/week score, and then summing the individual item caloric expenditure scores across all 28 items. This scale score was transformed into the unit of kcal. The minimum possible value of the scale is 0 and there is not a defined maximum possible value. Higher scores equate to more kilocalories burned per week, which is a better outcome in the context of this trial.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Postoperative Complications (Clavien-Dindo Grades I-V)', 'timeFrame': '12 weeks', 'description': 'Postoperative complications were assessed at 12 weeks following surgery using the Clavien-Dindo classification:\n\nGrade I: Any deviation from the normal postoperative course w/out the need for pharmacological treatment or surgical, endoscopic, and radiological interventions Grade II: Requiring pharmacological treatment w/ drug other than such allowed for Grade I complications Grade III: Requiring surgical, endoscopic or radiological intervention Grade IIIa: Intervention not under general anesthesia Grade IIIb: Intervention under general anesthesia Grave IV: Life-threatening complication Grade IVa: Single organ dysfunction Grade IVb: Multiorgan dysfunction Grave V: Death A generalized linear mixed model (with logit link function) with random practice effect to account for clustering within practice will be used to compare postoperative complications within 12 weeks of surgery between the combined OPTI-Surg no-coach \\& coach arms vs usual care followed by pairwise comparisons'}, {'measure': 'Compliance Rate With Administration of Edmonton Frail Scale (EFS)', 'timeFrame': 'Day of surgical consult', 'description': 'EFS is a validated measure of frailty that identifies distinct frailty domains that are potential targets for additional pre-operative optimization. For frailty domains that score 1 or 2 points, optimization referrals will be recommended. Clinic or research staff at sites randomized to OPTI-Surg intervention arms will screen and identify eligible patients for administration of the EFS and provide printed surgery preparation materials. A generalized linear mixed model (with logit link function) with a random practice effect to account for clustering within practice will be used to compare compliance rate for screening between the no-coach and coach arms.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malignant Neoplasm', 'Surgical Procedure, Unspecified', 'Health Care Provider', 'Carcinoma']}, 'referencesModule': {'references': [{'pmid': '37923529', 'type': 'DERIVED', 'citation': 'Zahrieh D, Croghan IT, Inselman JW, Mandrekar SJ. Guidelines for Data and Safety Monitoring in Pragmatic Randomized Clinical Trials Using Case Studies. Mayo Clin Proc. 2023 Nov;98(11):1712-1726. doi: 10.1016/j.mayocp.2023.02.019.'}]}, 'descriptionModule': {'briefSummary': "This trial studies how well the use of a pre-surgical toolkit (OPTI-Surg) works in improving surgical care and outcomes in older participants with cancer. In many elderly patients, surgery can greatly affect physical condition and the ability to return to pre-surgery levels of physical functioning. Providing pre-surgical recommendations may help improve participants' recovery rate and functioning after surgery.", 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To compare 8-week postoperative function among elderly patients between sites randomized to implement the OPTI-Surg toolkit with or without a coach versus sites randomized to usual care.\n\nSECONDARY OBJECTIVES:\n\nI. To compare postoperative morbidity between sites randomized to implement the OPTI-Surg toolkit with or without a coach versus sites randomized to usual care.\n\nII. To compare the penetration of the OPTI-Surg toolkit between sites randomized to implement the OPTI-Surg toolkit with a coach versus sites randomized to implement the OPTI-Surg toolkit without a coach.\n\nTrial Design:\n\nOUTLINE: Healthcare providers/institutions are randomized to 1 of 3 arms. Patients/participants receive the intervention based on which arm their healthcare provider is in.\n\nARM I: Healthcare providers/institutions perform usual care.\n\nARM II: Healthcare providers/institutions receive OPTI-Surg training and informational materials.\n\nARM III: Healthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach.\n\nAfter conclusion of study, participants are followed up at 8 and 12 weeks post surgery, and healthcare providers/institutions are followed up 6-9 months after the last patient is registered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have known or suspected cancer diagnosis and have one of the following cancer-directed operations planned:\n\n * Gastrectomy\n * Colectomy\n * Proctectomy\n * Esophagectomy\n * Pancreatectomy\n * Hepatectomy\n * Total cystectomy\n * Partial or total nephrectomy\n * Lung lobectomy/pneumonectomy\n* Patients with known metastatic disease with a plan for curative intent resection are eligible (e.g. curative liver resection for metastatic colorectal cancer).\n* Patients with double primaries undergoing planned curative operation for both are eligible (e.g. synchronous colon cancers undergoing colectomy to treat both).\n* Patients must be able to speak and complete questionnaires in English.\n\nExclusion Criteria:\n\n* Patients undergoing emergent surgery are not eligible.\n* Patients under active treatment such as chemotherapy, targeted therapy, immunotherapy, radiation treatment, etc. for second primary, are not eligible.\n* Patients with second primary are not eligible.\n* Patients with known metastatic disease who are undergoing palliative resection are not eligible.\n* Patients with psychiatric illness or other mental impairment that would preclude their ability to give informed consent or to participate in the prehabilitation program are not eligible.'}, 'identificationModule': {'nctId': 'NCT03857620', 'briefTitle': 'Use of a Pre-Surgical Toolkit in Improving Surgical Care and Outcomes in Older Participants With Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for Clinical Trials in Oncology'}, 'officialTitle': 'Improving Surgical Care and Outcomes in Older Cancer Patients Through Implementation of an Efficient Pre-Surgical Toolkit (OPTI-Surg)', 'orgStudyIdInfo': {'id': 'A231601CD'}, 'secondaryIdInfos': [{'id': 'NCI-2018-01512', 'type': 'REGISTRY', 'domain': 'NCI Clinical Trial Reporting Program'}, {'id': 'UG1CA189823', 'link': 'https://reporter.nih.gov/quickSearch/UG1CA189823', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm I (usual care)', 'description': 'Healthcare providers/institutions perform usual care.', 'interventionNames': ['Other: Best Practice', 'Other: Questionnaire Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (OPTI-Surg training and materials)', 'description': 'Healthcare providers/institutions receive OPTI-Surg training and informational materials.', 'interventionNames': ['Other: Informational Intervention', 'Other: Questionnaire Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Arm III (OPTI-Surg training and materials, coach)', 'description': 'Healthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach.', 'interventionNames': ['Other: Questionnaire Administration', 'Other: Informational Intervention with Coaching']}], 'interventions': [{'name': 'Best Practice', 'type': 'OTHER', 'description': 'Receive usual care', 'armGroupLabels': ['Arm I (usual care)']}, {'name': 'Informational Intervention', 'type': 'OTHER', 'description': 'Receive OPTI-Surg program materials', 'armGroupLabels': ['Arm II (OPTI-Surg training and materials)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (usual care)', 'Arm II (OPTI-Surg training and materials)', 'Arm III (OPTI-Surg training and materials, coach)']}, {'name': 'Informational Intervention with Coaching', 'type': 'OTHER', 'description': 'Receive OPTI-Surg program materials plus individual coaching', 'armGroupLabels': ['Arm III (OPTI-Surg training and materials, coach)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Helen F Graham Cancer Center', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Augusta University Medical Center', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '31404', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Memorial Health University Medical Center', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': "Queen's Medical Center", 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '60453-2699', 'city': 'Oak Lawn', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate Christ Medical Center', 'geoPoint': {'lat': 41.71087, 'lon': -87.75811}}, {'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'country': 'United States', 'facility': 'Carle Cancer Center', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}, {'zip': '50309', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa Methodist Medical Center', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '50314', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Mercy Medical Center - Des Moines', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Cancer Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '66205', 'city': 'Westwood', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Hospital-Westwood Cancer Center', 'geoPoint': {'lat': 39.04056, 'lon': -94.6169}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'LSU Healthcare Network / Metairie Multi-Specialty Clinic', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana State University Health Science Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '48106', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Saint Joseph Mercy Hospital', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Spectrum Health at Butterworth Campus', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '55435', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Fairview Southdale Hospital', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '55415', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Hennepin County Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55422', 'city': 'Robbinsdale', 'state': 'Minnesota', 'country': 'United States', 'facility': 'North Memorial Medical Health Center', 'geoPoint': {'lat': 45.03219, 'lon': -93.33856}}, {'zip': '38671', 'city': 'Southhaven', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Baptist Memorial Hospital and Cancer Center-Desoto', 'geoPoint': {'lat': 34.99176, 'lon': -90.12759}}, {'zip': '65804', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mercy Hospital Springfield', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '65807', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'CoxHealth South Hospital', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Morristown Medical Center', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '07902', 'city': 'Summit', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Overlook Hospital', 'geoPoint': {'lat': 40.71562, 'lon': -74.36468}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center-Einstein Campus', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center - Moses Campus', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novant Health Forsyth Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '58122', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Sanford Roger Maris Cancer Center', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '45459', 'city': 'Centerville', 'state': 'Ohio', 'country': 'United States', 'facility': 'Miami Valley Hospital South', 'geoPoint': {'lat': 39.62839, 'lon': -84.15938}}, {'zip': '18103', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lehigh Valley Hospital-Cedar Crest', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '17822', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger Medical Center', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Prisma Health Greenville Memorial Hospital', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Baptist Memorial Hospital and Cancer Center-Memphis', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '23235', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'VCU Massey Cancer Center at Stony Point', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University/Massey Cancer Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '53045', 'city': 'Brookfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Ascension Southeast Wisconsin Hospital - Elmbrook Campus', 'geoPoint': {'lat': 43.06057, 'lon': -88.10648}}, {'zip': '54701', 'city': 'Eau Claire', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Marshfield Medical Center-EC Cancer Center', 'geoPoint': {'lat': 44.81135, 'lon': -91.49849}}, {'zip': '53132', 'city': 'Franklin', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Ascension Southeast Wisconsin Hospital - Franklin', 'geoPoint': {'lat': 42.88863, 'lon': -88.03842}}, {'zip': '54449', 'city': 'Marshfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Marshfield Medical Center-Marshfield', 'geoPoint': {'lat': 44.66885, 'lon': -90.1718}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Aurora Saint Luke's Medical Center", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '54548', 'city': 'Minocqua', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Marshfield Clinic-Minocqua Center', 'geoPoint': {'lat': 45.87134, 'lon': -89.71098}}, {'zip': '54868', 'city': 'Rice Lake', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Marshfield Medical Center-Rice Lake', 'geoPoint': {'lat': 45.50607, 'lon': -91.73823}}, {'zip': '54482', 'city': 'Stevens Point', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Marshfield Medical Center-River Region at Stevens Point', 'geoPoint': {'lat': 44.52358, 'lon': -89.57456}}, {'zip': '54476', 'city': 'Weston', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Marshfield Medical Center - Weston', 'geoPoint': {'lat': 44.8908, 'lon': -89.54762}}], 'overallOfficials': [{'name': 'George J. Chang, MD, MS', 'role': 'STUDY_CHAIR', 'affiliation': 'The University of Texas MD Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alliance for Clinical Trials in Oncology', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}