Pilot Feasibility Study of a Dyadic Culinary Nutrition Intervention

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое Control
  Participants will receive written nutrition education developed for cancer survivors aligned with dietary recommendations.

Первичные конечные точки

• Feasibility measured by enrollment rate [Срок оценки: Up to 12 weeks]
• Appropriateness measured by retention rate [Срок оценки: Up to 24 weeks]
• Acceptability measured by adherence rate [Срок оценки: Up to 12 weeks]
• Composite measure of implementation success [Срок оценки: 12 weeks]

Вторичные конечные точки (2)

• Fruit and Vegetable Servings [Срок оценки: Baseline, 12 weeks, 24 weeks]
• Concentration of Carotenoid Biomarkers [Срок оценки: Baseline, 12 weeks, 24 weeks]

Критерии участия

Inclusion Criteria: Survivors

• 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.

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

• 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

Inclusion Criteria: Survivors and Caregivers

• 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

Exclusion Criteria: Survivors and Caregivers

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Arizona Cancer Center at UMC North/University Medical Center — Tucson

Идентификаторы

NCT: NCT07702864 · STUDY00008372 · 1R34CA304678-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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