Pilot Feasibility Study of a Dyadic Culinary Nutrition Intervention

NCT07702864 | Not Yet Recruiting

• 2 other identifiers: STUDY000083721R34CA304678-01A1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplams; Prostate Cancer (Adenocarcinoma); Cancer Survivors; Caregiver Burden; Nutrition Therapy

Keywords

Cancer survivorship; Caregivers; Hispanic; Men's Health; Nutrition; Pilot study

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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.

  Up to 12 weeks

• 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

Secondary Outcomes (2)

• Fruit and Vegetable Servings

  Baseline, 12 weeks, 24 weeks

• Concentration of Carotenoid Biomarkers

  Baseline, 12 weeks, 24 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Dyadic culinary nutrition program

Behavioral: Cooking Healthy - Engaging Families (CHEF)

Education Control

ACTIVE COMPARATOR

Nutrition education

Behavioral: Control

Interventions

Cooking Healthy - Engaging Families (CHEF) BEHAVIORAL

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.

Intervention

Control BEHAVIORAL

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

Education Control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Arizona Cancer Center at UMC North/University Medical Center

Tucson, Arizona, 85719, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma; Caregiver Burden

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Meghan Skiba, PhD, MS, MPH, RDN

  University of Arizona Mel and Enid Zuckerman College of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marjorie Nelson

CONTACT

520-626-3762; marjorienelson@arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 14, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)