Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT04597151
Status:
COMPLETED
Last Update Posted:
2023-01-09
First Post:
2020-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diet Education Program for Stage I-IV Colorectal Cancer Survivors
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': 'D004035', 'term': 'Diet Therapy'}], 'ancestors': [{'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-05', 'studyFirstSubmitDate': '2020-10-14', 'studyFirstSubmitQcDate': '2020-10-20', 'lastUpdatePostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Lifestyle Score on the National Institute of Health (NIH)/ National Cancer Institute (NCI) Automated Self- Administered 24-hour Dietary Assessment Tool (ASA24)', 'timeFrame': 'Up to 17 weeks', 'description': "The ASA24® Dietary Assessment Tool is a free, web-based tool that enables multiple, automatically coded, self-administered 24-hour diet recalls and/or single or multi-day food records, also known as food diaries. The ASA24 system consists of a respondent website used to collect dietary intake data and a researcher website used to manage study logistics and obtain nutrient and food group data files to obtain analysis files for 65 nutrients and 37 food groups. This data is used to generate a standardized lifestyle score pre- and post-intervention with possible range: 0-7, based on participant's body mass index and intake of fruits and vegetables, fiber, ultra-processed foods, red meat, processed meat, sugar-sweetened drinks, and alcohol. This standardized score quantifies the degree to which participants' lifestyles are consistent with the 2018 World Cancer Research Fund (WCRF) / American Institute of Cancer Research (AICR) Recommendations."}], 'primaryOutcomes': [{'measure': 'Percentage of participants missing questionnaires', 'timeFrame': 'Up to 17 weeks', 'description': 'Feasibility of measurement tools will be assessed by reporting the percentage of participants whom did not complete the questionnaires'}, {'measure': 'Follow-up response rates', 'timeFrame': 'Up to 17 weeks', 'description': 'Feasibility of measurement tools will be assessed by follow up response rates (week 6 and week 17)'}, {'measure': 'Frequency of reasons for not participating in questionnaires', 'timeFrame': 'Up to 17 weeks', 'description': 'Feasibility of measurement tools will be assessed by recording and reporting reasons for not taking part in questionnaires.'}, {'measure': 'Number of participants who consent or expressed interest', 'timeFrame': 'Up to 17 weeks', 'description': 'Subject recruitment will be assessed by number of participants who consent/number of participants who initially expressed interest, and reasons for non-participation will be documented.'}, {'measure': 'Percentage of consented patients who remain on the study', 'timeFrame': 'Up to 17 weeks', 'description': 'Subject retention will be assessed by percentage of consented patients who remain on the study at week 6 and at week 17, and reasons for dropout will be documented.'}, {'measure': 'Number of sessions attended', 'timeFrame': 'Up to 17 weeks', 'description': 'Adherence to diet education intervention will be assessed by number of sessions attended and reasons for absence will be documented.'}, {'measure': 'Categorical responses to program evaluation survey', 'timeFrame': 'Up to 17 weeks', 'description': 'Experience (e.g. satisfaction) will be assessed by tabulated responses to program evaluation survey. Qualitative analysis of cleaned and coded transcripts from interviews using a "constant comparison" process through which data are built into conceptual categories and themes will be performed.'}], 'secondaryOutcomes': [{'measure': 'Frequency of responses to the baseline socio-demographics survey', 'timeFrame': 'Up to 17 weeks', 'description': 'Barriers to healthy diet will be described using tabulated responses to the baseline socio-demographics survey and qualitative analysis of coded transcripts from baseline and exit interviews.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stage I Colorectal Cancer AJCC v8', 'Stage II Colorectal Cancer AJCC v8', 'Stage IIA Colorectal Cancer AJCC v8', 'Stage IIB Colorectal Cancer AJCC v8', 'Stage IIC Colorectal Cancer AJCC v8', 'Stage III Colorectal Cancer AJCC v8', 'Stage IIIA Colorectal Cancer AJCC v8', 'Stage IIIB Colorectal Cancer AJCC v8', 'Stage IIIC Colorectal Cancer AJCC v8', 'Stage IV Colorectal Cancer AJCC v8', 'Stage IVA Colorectal Cancer AJCC v8', 'Stage IVB Colorectal Cancer AJCC v8', 'Stage IVC Colorectal Cancer AJCC v8']}, 'descriptionModule': {'briefSummary': 'This pilot trial evaluates the feasibility of a group diet education program for stage I-IV colorectal cancer survivors. Providing a nutrition education program for colon and rectal cancer survivors may help them have better access to the tools necessary to make healthy food decisions that can impact their cancer outcomes.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To describe the feasibility and acceptability of a group diet education intervention for colorectal cancer (CRC) survivors at Zuckerberg San Francisco General Hospital (ZSFGH).\n\nSECONDARY OBJECTIVE:\n\nI. To describe perceived barriers to healthy diet among CRC survivors at ZSFGH.\n\nEXPLORATORY OBJECTIVES:\n\nI. To evaluate for differences in feasibility and acceptability of a group diet education program, based on sociodemographic factors such as education, food insecurity, employment, and race.\n\nII. To explore changes in health-related behaviors pre and post intervention using a validated lifestyle score.\n\nOUTLINE:\n\nPatients attend group diet education sessions over 1.5-2 hours every 2 weeks (weeks 1, 3, and 5).\n\nAfter completion of study, patients are followed up at 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to speak and read English or Spanish\n* Diagnosed with stage 1- 4 colorectal cancer within 5 years prior to study enrollment and treated with curative intent\n* Receiving survivorship follow up care at Zuckerberg San Francisco General Hospital (ZSFGH)\n* Able to provide written consent\n\nExclusion Criteria:\n\n* Currently receiving chemotherapy, biologic therapy, radiation, or immunotherapy for colorectal cancer'}, 'identificationModule': {'nctId': 'NCT04597151', 'briefTitle': 'Diet Education Program for Stage I-IV Colorectal Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Diet Education Among Colorectal Cancer Survivors in the Safety Net Setting: A Pilot Feasibility Study', 'orgStudyIdInfo': {'id': '204511'}, 'secondaryIdInfos': [{'id': 'NCI-2020-06808', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supportive care (diet education)', 'description': 'Patients attend group diet education sessions over 1.5-2 hours every 2 weeks (weeks 1, 3, and 5).', 'interventionNames': ['Dietary Supplement: Dietary Intervention']}], 'interventions': [{'name': 'Dietary Intervention', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Dietary Modification', 'intervention, dietary', 'Nutrition Intervention', 'Nutrition Interventions', 'Nutritional Interventions'], 'description': 'Attend diet education sessions', 'armGroupLabels': ['Supportive care (diet education)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Zuckerberg San Francisco General Hospital', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Sorbarikor Piawah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}