Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-25 @ 4:02 PM
Study NCT ID:
NCT05649969
Status:
COMPLETED
Last Update Posted:
2025-11-14
First Post:
2022-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
STRONG Program for Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012017', 'term': 'Referral and Consultation'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D011364', 'term': 'Professional Practice'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-01-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-12', 'studyFirstSubmitDate': '2022-12-06', 'studyFirstSubmitQcDate': '2022-12-06', 'lastUpdatePostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of the STRONG Program', 'timeFrame': 'at 12 weeks', 'description': 'Feasibility of the Support through Remote Observation and Nutrition Guidance (STRONG) program will be assessed using recruitment and retention rates, along with data completion rates.'}, {'measure': 'Acceptability of the STRONG Program', 'timeFrame': 'at 16 weeks', 'description': 'The Acceptability of the STRONG Program measure uses 4 items to indicate participant satisfaction. The measure uses a scale of 0-5, 0 meaning the participant completely disagrees with the statements regarding intervention satisfaction and 5 indicating complete agreement with the statements regarding intervention satisfaction. The measure score ranges from 0-20 with 20 indicating the highest degree of satisfaction.'}, {'measure': 'Adherence to the STRONG Program', 'timeFrame': 'at 16 weeks', 'description': 'Participant adherence to the Support through Remote Observation and Nutrition Guidance (STRONG) program will be assessed by Fitbit dietary log data and dietician care visit data.'}, {'measure': 'Efficacy of STRONG Program on Treatment Outcomes', 'timeFrame': 'at 16 weeks', 'description': 'Efficacy of STRONG program on treatment outcomes will be measured by reviewing the Electronic Health Record for hospital readmissions and cause of readmission'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastrointestinal Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.moffitt.org/clinical-trials-research/clinical-trials/', 'label': 'Moffitt Cancer Center Clinical Trials website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the feasibility and participant satisfaction with the Support through Remote Observation and Nutrition Guidance (STRONG) program. The program provides nutrition support for participants living with gastrointestinal cancer who are receiving chemotherapy and surgical treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gastrointestinal Cancer diagnosis (e.g., colon cancer, appendiceal cancer)\n* Peritoneal disease diagnosis\n* Received Cytoreductive Surgery and Heated Intra-Peritoneal Chemotherapy (CRS-HIPEC) for curative intent at Moffitt\n* Transitioned to an oral diet post-surgery\n* Able to speak and read English\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g., psychosis, active substance abuse)\n* Undergoing concurrent treatment for a secondary primary cancer\n* Receipt of parenteral or enteral nutrition after surgery'}, 'identificationModule': {'nctId': 'NCT05649969', 'briefTitle': 'STRONG Program for Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'H. Lee Moffitt Cancer Center and Research Institute'}, 'officialTitle': 'STRONG-PD: Support Through Remote Observation And Nutrition Guidance (STRONG) Program For Cancer Patients With Peritoneal Disease', 'orgStudyIdInfo': {'id': 'MCC-22117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'STRONG Program', 'description': 'the STRONG program includes consultations with a Moffitt dietician, logging intake of food daily into a food diary with a Fitbit smartphone app, and completing questionnaires.', 'interventionNames': ['Behavioral: Consultations with Moffitt Dietician', 'Behavioral: Daily Food Intake Diary with Fitbit smartphone application', 'Behavioral: Questionnaires']}], 'interventions': [{'name': 'Consultations with Moffitt Dietician', 'type': 'BEHAVIORAL', 'description': 'Participants will have an initial consultation with a dietician and then biweekly follow-up visits (in person or virtually) for 12 weeks.', 'armGroupLabels': ['STRONG Program']}, {'name': 'Daily Food Intake Diary with Fitbit smartphone application', 'type': 'BEHAVIORAL', 'description': 'Participants will keep a daily diary of food intake with a Fitbit smartphone application and wear a Fitbit for 12 weeks', 'armGroupLabels': ['STRONG Program']}, {'name': 'Questionnaires', 'type': 'BEHAVIORAL', 'description': 'Participants will complete a questionnaire electronically at baseline and again at week 4, 8, 12 and 16.', 'armGroupLabels': ['STRONG Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Amir Alishahi Tabriz, MD, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moffitt Cancer Center'}, {'name': 'Ben Powers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moffitt Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lee Moffitt Cancer Center and Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}