Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT07164456
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-10
First Post:
2025-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Together Stronger: A Family-centered Lifestyle Intervention for Black Prostate Cancer Survivors and Their Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 648}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-14', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2033-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2025-09-04', 'studyFirstSubmitQcDate': '2025-09-04', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2031-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical Activity Readiness Questionnaire', 'timeFrame': 'Through study completion; an average of 1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Family Centered', 'Black Ethnicity', 'Prostate Cancer Survivors']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'To establish the efficacy of the family-centered intervention in improving healthy lifestyle behaviors (MVPA and overall diet quality), as well as physical functioning, QoL, and family health climate, compared to survivor-only and control groups.', 'detailedDescription': 'Primary Objectives\n\n• Determine the extent to which MVPA and overall diet quality have improved in Black PCa survivors and their caregivers in the family-centered intervention group, compared to those in the survivor-only and control groups at post-intervention.\n\nSecondary Objectives\n\n* Determine the extent to which, compared to those in the survivor-only and control groups, both survivors and caregivers in the family-centered group maintain the MVPA and high diet quality at the 6-month follow-up, and experience improved 6MWT, QoL, and family health climate at both post-intervention and 6-month follow-up.\n* Identify mediators and moderators of the family-centered intervention.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'males', 'healthyVolunteers': False, 'eligibilityCriteria': 'Eligibility Criteria\n\nSurvivors are eligible if they\n\n* Are adults (≥18 years old)\n* Self-identify as Black or African American;\n* Were diagnosed with stage 0-III PCa; completed PCa treatment; (5) are able to be physically active, as determined by responses to the Physical Activity Readiness Questionnaire (PAR-Q); and\n* Have a family caregiver willing to participate together. Individuals under active surveillance for PCa will be included.\n\nCaregivers are eligible if they:\n\n* Are adults (≥18 years old)\n* Are able to be physically active, as determined by responses to the\n\nExclusion Criteria\n\nSurvivors are excluded if they:\n\n* Have a prior history of other cancer or have metastatic cancer.\n* Have planned concomitant immunotherapy, hormonal therapy, chemotherapy, or radiation therapy during the study period.\n* Meet physical activity recommendations (i.e., 150 min of moderate intensity physical activity per week); and (4) are currently participating in a lifestyle or weight management program.\n\nCaregivers are excluded if they:\n\n* Have serious medical conditions (e.g., cancer, congestive heart failure, stroke, and dementia)\n* Are currently participating in a lifestyle or weight management program.'}, 'identificationModule': {'nctId': 'NCT07164456', 'briefTitle': 'Together Stronger: A Family-centered Lifestyle Intervention for Black Prostate Cancer Survivors and Their Caregivers', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Together Stronger: A Family-centered Lifestyle Intervention for Black Prostate Cancer Survivors and Their Caregivers', 'orgStudyIdInfo': {'id': '2025-0868'}, 'secondaryIdInfos': [{'id': 'NCI-2025-06570', 'type': 'OTHER', 'domain': 'NCI-CTRP Clinical Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Family-centered intervention', 'description': 'Includes a nutrition education session, a PA education session, and 12 health-coaching calls, all conducted via Zoom or phone.', 'interventionNames': ['Other: Education sessions', 'Other: Questionnaire']}, {'type': 'EXPERIMENTAL', 'label': 'survivor-only intervention', 'description': 'Includes a nutrition education session, a PA education session, and 12 health-coaching calls, all conducted via Zoom or phone.', 'interventionNames': ['Other: Education sessions', 'Other: Questionnaire']}, {'type': 'EXPERIMENTAL', 'label': 'Health education control', 'description': "Will focus on enhancing participants' intrinsic motivation and problem-solving skills related to improving diet quality and engaging in PA. A total of 12 sessions will be provided, with approximately 2 sessions per month", 'interventionNames': ['Other: Education sessions', 'Other: Questionnaire']}], 'interventions': [{'name': 'Education sessions', 'type': 'OTHER', 'description': 'Remote and In person sessions', 'armGroupLabels': ['Family-centered intervention', 'Health education control', 'survivor-only intervention']}, {'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Questionnaires given a 3,6,12 mouth follow ups', 'armGroupLabels': ['Family-centered intervention', 'Health education control', 'survivor-only intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Dalnim Cho, MD', 'role': 'CONTACT', 'email': 'dcho1@mdanderson.org', 'phone': '713-745-8476'}, {'name': 'Dalnim Cho, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Dalnim Cho, MD', 'role': 'CONTACT', 'email': 'dcho1@mdanderson.org', 'phone': '713-745-8476'}], 'overallOfficials': [{'name': 'Dalnim Cho, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MD Andersson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}