Pilot Feasibility Study of a Dyadic Culinary Nutrition Intervention (CHEF)

July 8, 2026 updated by: University of Arizona
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Arizona Cancer Center at UMC North/University Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Dyadic culinary nutrition program
Behavioral: 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.
Active Comparator: Education Control
Nutrition education
Behavioral: Control
Participants will receive written nutrition education developed for cancer survivors aligned with dietary recommendations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility measured by enrollment rate
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.
Up to 12 weeks
Appropriateness measured by retention rate
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.
Up to 24 weeks
Acceptability measured by adherence rate
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.
Up to 12 weeks
Composite measure of implementation success
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fruit and Vegetable Servings
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.
Baseline, 12 weeks, 24 weeks
Concentration of Carotenoid Biomarkers
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.
Baseline, 12 weeks, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Investigators

  • Principal Investigator: Meghan Skiba, PhD, MS, MPH, RDN, University of Arizona Mel and Enid Zuckerman College of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

April 30, 2028

Study Registration Dates

First Submitted

July 2, 2026

First Submitted That Met QC Criteria

July 8, 2026

First Posted (Actual)

July 14, 2026

Study Record Updates

Last Update Posted (Actual)

July 14, 2026

Last Update Submitted That Met QC Criteria

July 8, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00008372
  • 1R34CA304678-01A1 (Other Grant/Funding Number: NCI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Caregiver Burden

Clinical Trials on Cooking Healthy - Engaging Families (CHEF)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe