Cancer Survivors, Caregiver Burden, Neoplams, Nutrition Therapy, Prostate Cancer (Adenocarcinoma)
Conditions
Keywords
Cancer survivorship, Caregivers, Hispanic, Men's Health, Nutrition, Pilot study
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALCooking 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.
BEHAVIORALControl
Participants will receive written nutrition education developed for cancer survivors aligned with dietary recommendations.
Sponsors
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Using a randomized control trial design, we will randomize 20 Hispanic prostate cancer survivors and 20 co-residing caregivers together as dyads (total n=40) to either culinary nutrition intervention or education control. We will assess feasibility via recruitment, retention, adherence, and acceptability.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility measured by enrollment rate | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fruit and Vegetable Servings | 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. |
| Concentration of Carotenoid Biomarkers | 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. |
Countries
United States
Contacts
CONTACTMarjorie Nelson
PRINCIPAL_INVESTIGATORMeghan Skiba, PhD, MS, MPH, RDN
University of Arizona Mel and Enid Zuckerman College of Public Health
Outcome results
None listed