[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07164456":3,"trial-entities:NCT07164456":89,"trial-summary:NCT07164456":93},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":41,"secondary_outcomes":45,"sex":46,"minimum_age":47,"maximum_age":48,"healthy_volunteers":49,"eligibility_criteria":50,"std_ages":59,"locations":62,"central_contacts":80,"overall_officials":82,"references":85,"see_also_links":86},"NCT07164456","2025-0868","Together Stronger: A Family-centered Lifestyle Intervention for Black Prostate Cancer Survivors and Their Caregivers","RECRUITING","2033-06-30","2026-03","2026-03-09","2026-01-13","M.D. Anderson Cancer Center","OTHER",true,"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.","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.",[18,19,20],"Family Centered","Black Ethnicity","Prostate Cancer Survivors",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[25],"NA",{"count":27,"type":28},648,"ESTIMATED",[30,37],{"type":13,"name":31,"description":32,"armGroupLabels":33},"Education sessions","Remote and In person sessions",[34,35,36],"Family-centered intervention","Health education control","survivor-only intervention",{"type":13,"name":38,"description":39,"armGroupLabels":40},"Questionnaire","Questionnaires given a 3,6,12 mouth follow ups",[34,35,36],[42],{"measure":43,"timeFrame":44},"Physical Activity Readiness Questionnaire","Through study completion; an average of 1 year",[],"MALE","18 Years",null,false,{"inclusion":51,"exclusion":52,"raw_text":58},[],[53,54,55,56,57],"Have a prior history of other cancer or have metastatic cancer.","Have planned concomitant immunotherapy, hormonal therapy, chemotherapy, or radiation therapy during the study period.","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.","Have serious medical conditions (e.g., cancer, congestive heart failure, stroke, and dementia)","Are currently participating in a lifestyle or weight management program.","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.",[60,61],"ADULT","OLDER_ADULT",[63],{"facility":64,"status":7,"city":65,"state":66,"zip":67,"country":68,"contacts":69,"geoPoint":77},"MD Anderson Cancer Center","Houston","Texas","77030","United States",[70,75],{"name":71,"role":72,"phone":73,"email":74},"Dalnim Cho, MD","CONTACT","713-745-8476","dcho1@mdanderson.org",{"name":71,"role":76},"PRINCIPAL_INVESTIGATOR",{"lat":78,"lon":79},29.76328,-95.36327,[81],{"name":71,"role":72,"phone":73,"email":74},[83],{"name":71,"affiliation":84,"role":76},"MD Andersson Cancer Center",[],[87],{"label":64,"url":88},"http:\u002F\u002Fwww.mdanderson.org",{"nct_id":4,"conditions":90,"biomarkers":92},[91],"Prostate Carcinoma",[],{"nct_id":4,"found":14,"summary":94,"prompt_version":104},{"design":95,"status":96,"heading":97,"summary":98,"follow_up":99,"word_count":100,"commitments":101,"compensation":102,"drugs_mentioned":103},"This interventional study plans to enroll 648 participants. The study is designed to compare a family-centered intervention to survivor-only and control groups.","completed","Together Stronger: A Family-centered Lifestyle Intervention for Black Prostate Cancer Survivors","This study, called \"Together Stronger,\" is testing a family-centered program to help Black prostate cancer survivors and their caregivers live healthier lifestyles. The program involves education sessions, which can be done remotely or in person. Researchers want to see if this family-focused approach improves healthy behaviors like physical activity and diet quality, as well as overall well-being and family health, compared to programs for survivors only or a control group. You may be able to join if you are an adult Black man who has completed treatment for stage 0-III prostate cancer, are able to be physically active, and have a family caregiver willing to participate with you. The study aims to understand how well these lifestyle changes are maintained over time. The current recruitment status is unclear.","Participants will be followed through study completion, which is an average of 1 year, with questionnaires at 3, 6, and 12 months.",128,"Participants will attend remote or in-person education sessions and complete questionnaires at 3, 6, and 12 months after the intervention.","Not stated in the trial record.",[31],"v2"]