Pilot Feasibility Study of a Dyadic Culinary Nutrition Intervention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Feasibility measured by enrollment rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Intervention
Dyadic culinary nutrition program
干预措施: Cooking Healthy - Engaging Families (CHEF) (Behavioral)
Education Control
Nutrition education
干预措施: Control (Behavioral)
结局指标
主要结局
Feasibility measured by enrollment rate
时间窗: 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.
Appropriateness measured by retention rate
时间窗: 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.
Acceptability measured by adherence rate
时间窗: 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.
Composite measure of implementation success
时间窗: 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.
次要结局
- Fruit and Vegetable Servings(Baseline, 12 weeks, 24 weeks)
- Concentration of Carotenoid Biomarkers(Baseline, 12 weeks, 24 weeks)