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NCT Number: NCT07702864

Pilot Feasibility Study of a Dyadic Culinary Nutrition Intervention

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona Cancer Center at UMC North/University Medical Center

Tucson, Arizona, 85719, United States

Location contact

Meghan Skiba, PhD, MS, MPH, RDN

CONTACT

[email protected]

520-621-9036

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Control

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marjorie Nelson

CONTACT

[email protected]

520-626-3762

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Acronym: CHEF

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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