[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07702864":3,"trial-entities:NCT07702864":126,"trial-summary:NCT07702864":130},{"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":23,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":34,"interventions":37,"primary_outcomes":49,"secondary_outcomes":65,"sex":73,"minimum_age":74,"maximum_age":75,"healthy_volunteers":76,"eligibility_criteria":77,"std_ages":96,"locations":99,"central_contacts":115,"overall_officials":120,"references":124,"see_also_links":125},"NCT07702864","STUDY00008372","Pilot Feasibility Study of a Dyadic Culinary Nutrition Intervention","NOT_YET_RECRUITING","2028-04-30","2026-07","2026-07-14","2027-01-01","University of Arizona","OTHER",false,"This study will determine the feasibility and acceptability of a 12-week dyadic culinary nutrition program among Hispanic prostate cancer survivor\u002Fcaregiver dyads using a randomized controlled trial design.","Prostate cancer is the most common cancer among Hispanic\u002FLatino men. Following treatment, both survivors and their family caregivers often experience long-term side effects that can be managed through diet. However, few survivors or caregivers meet current nutritional guidelines, and most interventions focus solely on the patient. Because co-residing couples share meals and routines, targeting the survivor-caregiver dyad together may be more effective for dietary modification. This pilot study evaluates \"Cooking Healthy - Engaging Families\" (CHEF), a remote, dyadic culinary nutrition program designed to improve dietary intake for Hispanic prostate cancer survivors and caregivers.\n\nThis pilot study utilizes a randomized controlled trial (RCT) design to determine the feasibility and acceptability of the CHEF intervention.The study aims to recruit 20 dyads (n=40 total participants) meeting the following criteria:\n\nSurvivors: Hispanic men post-treatment for prostate cancer (≥ 6 weeks from completion of primary curative treatment).\n\nCaregivers: Informal, co-residing caregivers of the enrolled survivors.\n\nParticipants will be randomized to evaluate the program's delivery, engagement, and acceptability in a remote format. Additionally, the study will explore secondary outcomes, including changes in dietary intake and serum carotenoid levels.",[18,19,20,21,22],"Neoplams","Prostate Cancer (Adenocarcinoma)","Cancer Survivors","Caregiver Burden","Nutrition Therapy",[24,25,26,27,28,29],"Cancer survivorship","Caregivers","Hispanic","Men's Health","Nutrition","Pilot study","INTERVENTIONAL","SUPPORTIVE_CARE",[33],"NA",{"count":35,"type":36},40,"ESTIMATED",[38,44],{"type":39,"name":40,"description":41,"armGroupLabels":42},"BEHAVIORAL","Cooking Healthy - Engaging Families (CHEF)","The intervention is a remote dyadic culinary nutrition program that occurs over 12-weeks with 24 total hours of intervention. The intervention includes nutrition education, cooking classes, and health coaching. All sessions are available in English and Spanish and will be held virtually through video-conferencing software and a restricted access website.",[43],"Intervention",{"type":39,"name":45,"description":46,"armGroupLabels":47},"Control","Participants will receive written nutrition education developed for cancer survivors aligned with dietary recommendations.",[48],"Education Control",[50,54,58,61],{"measure":51,"description":52,"timeFrame":53},"Feasibility measured by enrollment rate","Will be determined as the enrollment rate- the number of dyads enrolled out of those approached and eligible using descriptive statistics.","Up to 12 weeks",{"measure":55,"description":56,"timeFrame":57},"Appropriateness measured by retention rate","Will be determined as the retention rate- calculated as the number of dyads (survivor-caregiver pairs) completing the study versus dyads consented using descriptive statistics.","Up to 24 weeks",{"measure":59,"description":60,"timeFrame":53},"Acceptability measured by adherence rate","Acceptability will be measured by adherence rate to the intervention calculated as the total number of classes attended divided by the total possible schedule the patient could attend using descriptive statistics.",{"measure":62,"description":63,"timeFrame":64},"Composite measure of implementation success","Implementation success will be measured by a single composite questionnaire that will determine the extent to which the intervention is considered feasible, appropriate, and acceptable. Responses are summary scored with a possible range of 4-20; higher scores indicate greater feasibility, appropriateness, and acceptability.","12 weeks",[66,70],{"measure":67,"description":68,"timeFrame":69},"Fruit and Vegetable Servings","24-hour dietary recalls by blinded trained assessors on one weekday and one weekend day via telephone. Output is used to calculate fruit and vegetable servings.","Baseline, 12 weeks, 24 weeks",{"measure":71,"description":72,"timeFrame":69},"Concentration of Carotenoid Biomarkers","Carotenoids (beta-carotene, lutein, zeaxanthin, and lycopene) will be analyzed using blood samples obtained using a self-administered dried blood spot (DBS) collection.","ALL","18 Years","90 Years",true,{"inclusion":78,"exclusion":89,"raw_text":95},[79,80,81,82,83,84,85,86,87,88],"History of prostate cancer diagnosis at any stage (I-IV)","Identifies as Hispanic","Completed primary curative treatment (e.g., chemotherapy, radiation, surgery) 6 weeks prior to enrollment.","Provides unpaid support for the cancer survivor","No prior history of cancer (except non-melanoma skin cancer) Note: Caregivers do not need to identify as Hispanic to be eligible","Aged 18-90 years","Reports low fruit and vegetable intake","Able to write, read, and speak in English or Spanish","Access to a mobile device with Internet and a camera","Co-residing and able to participate at the same time and location",[90,91,92,93,94],"Cognitive difficulties that preclude answering the survey questions, that answering survey questions or participating in study activities, or providing informed consent.","A medical condition, movement or neurological disorder, or medication use that contraindicates participation in meal preparation.","Not co-residing (live in the separate households).","No survivor or caregiver available or willing to participate simultaneously.","Less than 18 years or greater than 90 years of age.","Inclusion Criteria: Survivors\n\n* History of prostate cancer diagnosis at any stage (I-IV)\n* Identifies as Hispanic\n* Completed primary curative treatment (e.g., chemotherapy, radiation, surgery) 6 weeks prior to enrollment.\n\nNote: Men on continuing hormone therapy (ADT) or immunotherapy as maintenance or consolidation treatment are eligible. Men on active surveillance only (no treatment) are not eligible.\n\nInclusion Criterion: Caregivers\n\n* Provides unpaid support for the cancer survivor\n* No prior history of cancer (except non-melanoma skin cancer) Note: Caregivers do not need to identify as Hispanic to be eligible\n\nInclusion Criteria: Survivors and Caregivers\n\n* Aged 18-90 years\n* Reports low fruit and vegetable intake\n* Able to write, read, and speak in English or Spanish\n* Access to a mobile device with Internet and a camera\n* Co-residing and able to participate at the same time and location\n\nExclusion Criteria: Survivors and Caregivers\n\n* Cognitive difficulties that preclude answering the survey questions, that answering survey questions or participating in study activities, or providing informed consent.\n* A medical condition, movement or neurological disorder, or medication use that contraindicates participation in meal preparation.\n* Not co-residing (live in the separate households).\n* No survivor or caregiver available or willing to participate simultaneously.\n* Less than 18 years or greater than 90 years of age.",[97,98],"ADULT","OLDER_ADULT",[100],{"facility":101,"city":102,"state":103,"zip":104,"country":105,"contacts":106,"geoPoint":112},"Arizona Cancer Center at UMC North\u002FUniversity Medical Center","Tucson","Arizona","85719","United States",[107],{"name":108,"role":109,"phone":110,"email":111},"Meghan Skiba, PhD, MS, MPH, RDN","CONTACT","520-621-9036","mbskiba@arizona.edu",{"lat":113,"lon":114},32.22174,-110.92648,[116],{"name":117,"role":109,"phone":118,"email":119},"Marjorie Nelson","520-626-3762","marjorienelson@arizona.edu",[121],{"name":108,"affiliation":122,"role":123},"University of Arizona Mel and Enid Zuckerman College of Public Health","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":127,"biomarkers":129},[128],"Prostate Carcinoma",[],{"nct_id":4,"found":76,"summary":131,"prompt_version":139},{"design":132,"status":133,"heading":6,"summary":134,"follow_up":132,"word_count":135,"commitments":136,"compensation":137,"drugs_mentioned":138},"Not specified.","completed","{\n   \"Pilot Study: Cooking Healthy - Engaging Families (CHEF) for Prostate Cancer Survivors and Caregivers\",\n   \"This study is testing a 12-week remote program called \\\"Cooking Healthy - Engaging Families (CHEF)\\\" for Hispanic prostate cancer survivors and their caregivers. The program includes nutrition education, cooking classes, and health coaching, and is available in English and Spanish. Some participants will receive written nutrition education instead. The study wants to see if the CHEF program is practical and well-received. We are looking for 40 participants (20 pairs of survivors and their caregivers). To join, you must be a Hispanic man, aged 18-90, who has completed primary treatment for prostate cancer at least 6 weeks ago. Your caregiver must live with you. This study is a pilot, meaning it's an early step to see if the program works well before a larger study.\",\n  \"design\": \"This is a randomized controlled pilot study involving 40 participants (20 survivor-caregiver pairs). Participants will be randomly assigned to either the CHEF program or a group receiving written nutrition education.\",\n  \"commitments\": \"Participants will take part in a 12-week remote program that includes 24 hours of intervention. The study will measure feasibility and acceptability for up to 12 weeks, and retention for up to 24 weeks.\",\n  \"compensation\": \"Not stated in the trial record.\",\n  \"follow_up\": \"Participants will be followed for retention for up to 24 weeks after enrollment.\",\n}",227,"Not specified in the trial record.","Not stated in the trial record.",[40,45],"v2"]