Arizona Cancer Center at UMC North/University Medical Center
Tucson, Arizona, 85719, United States
NCT Number: NCT07702864
This study will determine the feasibility and acceptability of a 12-week dyadic culinary nutrition program among Hispanic prostate cancer survivor/caregiver dyads using a randomized controlled trial design.
Trial opening soon.
Get Notified18 year–90 year
All sexes
Interventional
Not applicable
Tucson, Arizona, 85719, United States
Prostate cancer is the most common cancer among Hispanic/Latino 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.
This 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:
Survivors: Hispanic men post-treatment for prostate cancer (≥ 6 weeks from completion of primary curative treatment).
Caregivers: Informal, co-residing caregivers of the enrolled survivors.
Participants 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Survivors
Note: 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.
Inclusion Criterion: Caregivers
Inclusion criteria
Survivors and Caregivers
Exclusion criteria
Survivors and Caregivers
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.
Participants will receive written nutrition education developed for cancer survivors aligned with dietary recommendations.
Time frame: Up to 12 weeks
Will be determined as the enrollment rate- the number of dyads enrolled out of those approached and eligible using descriptive statistics.
Time frame: Up to 24 weeks
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.
Time frame: Up to 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: Baseline, 12 weeks, 24 weeks
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.
Time frame: Baseline, 12 weeks, 24 weeks
Carotenoids (beta-carotene, lutein, zeaxanthin, and lycopene) will be analyzed using blood samples obtained using a self-administered dried blood spot (DBS) collection.
Contact information is provided by the study sponsor or research team.
University of Arizona
Other
Acronym: CHEF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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