Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2026-02-25 @ 8:31 PM
Study NCT ID:
NCT03642093
Status:
UNKNOWN
Last Update Posted:
2018-09-11
First Post:
2018-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HOPE - A Study to Evaluate the Effect of a Prehabilitation Program on GI Cancer Patients Planning to Undergo Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093702', 'term': 'Immunonutrition Diet'}], 'ancestors': [{'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-07', 'studyFirstSubmitDate': '2018-06-20', 'studyFirstSubmitQcDate': '2018-08-20', 'lastUpdatePostDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frailty Measurement', 'timeFrame': '4 Weeks', 'description': 'Frailty will be measured using 3 criteria: weight loss, grip strength, and prealbumin serum level'}], 'secondaryOutcomes': [{'measure': 'Vitamin levels', 'timeFrame': '4 Weeks'}, {'measure': 'Quality of Life (QoL) Assessment', 'timeFrame': '4 Weeks', 'description': 'QoL will be assessed using Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Questionnaire - PROMIS Scale v1.2 - Global Health'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Frailty', 'Prehabilitation'], 'conditions': ['Pancreatic Cancer', 'Esophageal Cancer', 'Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'A one-group prospective cohort study design with measures collected pre- and post-intervention. The primary goal of this study is to evaluate the effect of a multimodal prehabilitation preoperative program on changes in frailty in upper gastrointestinal surgical oncology patients.', 'detailedDescription': 'Cancer patients often develop protein calorie malnutrition, inflammatory states, and loss of lean muscle mass, which can be best categorized as frailty. Frailty affects global health, the ability to carry out normal functions, and even the ability to tolerate targeted curative treatments such as surgery, chemotherapy, and radiation. The Investigators evaluate frailty, and design a study to evaluate the outcomes of the administration of multimodal preoperative prehabilitation programs on those frailty markers. Previous data provides support for interventions that include:\n\n1. Improved protein rich nutrition with specific immunonutrition recommendations,\n2. Treatment of maldigestion or pancreatic insufficiency in pancreatic, gastric, or esophageal cancer patients,\n3. Brief, evidence-based activity interventions such as walking and inspiratory muscle training (IMT), and\n4. Disease specific education\n\nThese interventions should improve frailty by maintaining or regaining weight, improved grip strength, and improved prealbumin. These markers indicate improvements in nutritional status, increased strength and ability to ambulate, and improved functional status in the preoperative period. Other outcomes that will be reported include fat-soluble vitamin levels, global health, and inflammation.\n\nThe preoperative period is the best time to facilitate patient engagement through self-care and proactive activity. Interventions must be easy to accomplish and structured so patients have accountability and both patients and clinicians have methods and tools for measuring progress. Most patients and family members are motivated at this time and understand the need to improve frailty and potentially improve global health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients must be patients of Ochsner being seen at the Ochsner Medical Center (OMC).\n* All patients must be 25 to 80 years of age.\n* All patients must have a diagnosis of cancer.\n* \\> 10 pound unintentional weight loss within 1 year\n* Ability to perform grip strength test and Timed Up and Go (TUG) test\n* Willingness to participate in the study, document compliance, and attend clinical appointments\n* All patients must be undergoing one of the following major elective surgical oncologic resections with curative intent:\n\n * Pancreaticoduodenectomy for pancreatic cancer\n * Distal pancreatectomy / splenectomy for pancreatic cancer\n * Esophageal robotic assisted laparoscopic thoracoscopic esophagectomy for esophageal cancer\n * Laparoscopic or open, partial or total gastrectomy for gastric cancer\n\nExclusion Criteria:\n\n* All patients not undergoing oncologic or major resections.\n* All patients unwilling or unable to answer questionnaires or accept help to answer electronic or paper questionnaires.\n* All patients that are unable to participate in an activity program.\n* All patients unable to wear an electronic activity monitoring device.\n* All patients not wanting to follow a specific nutritional and breathing intervention.\n* All patients that are not able or wishing to consent.'}, 'identificationModule': {'nctId': 'NCT03642093', 'acronym': 'HOPE', 'briefTitle': 'HOPE - A Study to Evaluate the Effect of a Prehabilitation Program on GI Cancer Patients Planning to Undergo Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ochsner Health System'}, 'officialTitle': 'H.O.P.E. Healing Optimization Through Preoperative Engagement: A Prospective Single Cohort Study to Evaluate the Effect of a Prehabilitation Program on Preoperative Outcomes in Upper GI Surgical Oncology Patients', 'orgStudyIdInfo': {'id': 'HOPE Study 2018.045'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Frail', 'description': 'Subjects assessed and determined to be Frail and meet trial eligibility criteria will be enrolled on Frail Arm and begin a 4 Week program consisting of Nutritional Interventions and Physical Activity Interventions', 'interventionNames': ['Combination Product: Nutritional Intervention', 'Behavioral: Physical Activity Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Not Frail', 'description': 'Subjects assessed and determined to be Not Frail and meet trial eligibility criteria will be enrolled on Not Frail Arm and begin a 4 Week program consisting of Nutritional Interventions and Physical Activity Interventions', 'interventionNames': ['Combination Product: Nutritional Intervention', 'Behavioral: Physical Activity Intervention']}], 'interventions': [{'name': 'Nutritional Intervention', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Immunonutrition'], 'description': 'Nutritional Supplementation for all subjects and Pancreatic Enzyme Replacement Therapy only for subjects with Exocrine Pancreatic Insufficiency', 'armGroupLabels': ['Frail', 'Not Frail']}, {'name': 'Physical Activity Intervention', 'type': 'BEHAVIORAL', 'description': 'Walking and Inspiratory Muscle Training', 'armGroupLabels': ['Frail', 'Not Frail']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70471', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}], 'overallOfficials': [{'name': 'Siobhan M Trotter, DNP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ochsner Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Siobhan Trotter', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Nurse Practitioner, Preoperative Optimization Program, Surgical Oncology and General Surgery', 'investigatorFullName': 'Siobhan Trotter', 'investigatorAffiliation': 'Ochsner Health System'}}}}