Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-01-05 @ 4:06 AM
Study NCT ID:
NCT03277235
Status:
COMPLETED
Last Update Posted:
2025-08-17
First Post:
2017-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Resilience Model-Based Program for Patients With Newly Diagnosed Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2017-09-07', 'studyFirstSubmitQcDate': '2017-09-07', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resilience scale', 'timeFrame': 'Change from baseline resilience at 12 months', 'description': 'The questionnaire includes 25 items to assess levels of resilience'}], 'secondaryOutcomes': [{'measure': 'Symptom Severity Scale', 'timeFrame': 'Change from baseline symptom at 12 months', 'description': 'The questionnaire includes 24 items to assess symptom severity'}, {'measure': 'Fatigue Symptom Inventory', 'timeFrame': 'Change from baseline fatigue at 12 months', 'description': 'The questionnaire includes 14 items to assess fatigue'}, {'measure': 'Center for Epidemiological Studies Depression Scale', 'timeFrame': 'Change from baseline depressive symptoms at 12 months', 'description': 'The questionnaire includes 20 items to assess depressive symptoms'}, {'measure': 'Fear of Cancer Recurrence Inventory-Short Form', 'timeFrame': 'Change from baseline fear of cancer recurrence at 12 months', 'description': 'The questionnaire includes 9 items to assess fear of cancer recurrence'}, {'measure': 'Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being Scale', 'timeFrame': 'Change from baseline spiritual well-being at 12 months', 'description': 'The questionnaire includes 12 items to assess spiritual well-being'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['resilience', 'cancer prehabilitation', 'physical distress', 'psychological distress', 'spiritual well-being', 'colorectal cancer'], 'conditions': ['Colorectal Cancer (MSI-H)']}, 'referencesModule': {'references': [{'pmid': '40232818', 'type': 'DERIVED', 'citation': 'Chou YJ, Lee YH, Lin BR, Jiang JK, Yang HY, Lin HY, Shun SC. Serial multiple mediation model of fear of cancer recurrence in patients with colorectal cancer. Health Psychol. 2025 Oct;44(10):955-962. doi: 10.1037/hea0001483. Epub 2025 Apr 14.'}, {'pmid': '38517612', 'type': 'DERIVED', 'citation': 'Liao YT, Chou YJ, Wu CT, Liu YH, Liang JT, Lai F, Shun SC. Wearable mobile health device for monitoring postoperative ambulation among patients with colorectal cancer undergoing minimally invasive surgery: A prospective comparison study. Int J Med Robot. 2024 Apr;20(2):e2626. doi: 10.1002/rcs.2626.'}, {'pmid': '34870940', 'type': 'DERIVED', 'citation': 'Chou YJ, Lin HY, Cooper BA, Lin BR, Jiang JK, Yang HY, Miaskowski C, Shun SC. A Resilience Model for Patients With Colorectal Cancer: A Structural Equation Modeling Analysis. Cancer Nurs. 2022 Jan-Feb 01;45(1):E83-E90. doi: 10.1097/NCC.0000000000000882.'}]}, 'descriptionModule': {'briefSummary': 'To develop a resilience model-based cancer prehabilitation program and evaluate its efficacy in improving resilience, alleviating symptoms, and enhancing spiritual well-being in patients with newly diagnosed colorectal cancer.', 'detailedDescription': 'Develop and evaluate the effect of a resilience model-based total care plan on reducing fear of recurrence and GI symptom distress, resilience and improving spiritual well-being in this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'The inclusion criteria were as follows: being aged ≧ 20 years, receiving a new diagnosis of stage 0-III colorectal cancer and being scheduled to undergo surgery, being aware of the diagnosis, being able to communicate in Mandarin or Taiwanese, and providing written informed consent. The exclusion criteria were as follows: receiving a diagnosis of stage IV colorectal cancer, having recurrent colorectal cancer or multiple cancers, and having a history of psychiatric disorders.'}, 'identificationModule': {'nctId': 'NCT03277235', 'briefTitle': 'Effect of a Resilience Model-Based Program for Patients With Newly Diagnosed Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Effectiveness of a Resilience Model-Based Cancer Prehabilitation Program for Patients With Newly Diagnosed Colorectal Cancer: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '201612224RIND'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Resilience model-based cancer prehabilitation program plus standard care', 'description': '12-week care plan with 5 in-person and 12 remote sessions, including both physical and psychological components.', 'interventionNames': ['Behavioral: Resilience model-based total care plan']}, {'type': 'OTHER', 'label': 'Control', 'description': 'standard care', 'interventionNames': ['Behavioral: Standard Care (in control arm)']}], 'interventions': [{'name': 'Resilience model-based total care plan', 'type': 'BEHAVIORAL', 'description': '12-week care plan with 5 times face-to-face intervention and weekly phone call follow-up to increase the protective factors (positive thinking. problem-solving, finding meaning, and social connection) and decrease the risk factors (disease-related distress and defense coping) of resilience', 'armGroupLabels': ['Resilience model-based cancer prehabilitation program plus standard care']}, {'name': 'Standard Care (in control arm)', 'type': 'BEHAVIORAL', 'description': 'standard care', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Shiow-Ching Shun, PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'National Taiwan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Science and Technology Council, Taiwan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}