NeoplamsCHEFNCT07702864
Pilot Feasibility Study of a Dyadic Culinary Nutrition Intervention
A study testing Cooking Healthy - Engaging Families (CHEF) in people with Neoplams and Prostate Cancer (Adenocarcinoma), run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Neoplams, Prostate Cancer (Adenocarcinoma), Cancer Survivors
- What is being tested?
- Cooking Healthy - Engaging Families (CHEF)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Arizona Cancer Center at UMC North/University Medical Center
Tucson, Arizona, 85719
Meghan Skiba, PhD, MS, MPH, RDN, 520-621-9036, mbskiba@arizona.edu
About this study
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.
Read the 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.
- Conditions
- Neoplams, Prostate Cancer (Adenocarcinoma), Cancer Survivors, Caregiver Burden, Nutrition Therapy
- Being tested
- Cooking Healthy - Engaging Families (CHEF), Control
- Keywords
- Cancer survivorship, Caregivers, Hispanic, Men's Health, Nutrition, Pilot study
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooking Healthy - Engaging Families (CHEF)Behavioural
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.
ControlBehavioural
Participants will receive written nutrition education developed for cancer survivors aligned with dietary recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Dyadic culinary nutrition program Receives: Behavioral: Cooking Healthy - Engaging Families (CHEF) |
| Education Control | Active comparator | Nutrition education Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (2)
Fruit and Vegetable Servings
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.
Measured: Baseline, 12 weeks, 24 weeks
Concentration of Carotenoid Biomarkers
Carotenoids (beta-carotene, lutein, zeaxanthin, and lycopene) will be analyzed using blood samples obtained using a self-administered dried blood spot (DBS) collection.
Measured: Baseline, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplamsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meghan Skiba, PhD, MS, MPH, RDN, Principal investigator, University of Arizona Mel and Enid Zuckerman College of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702864
- Sponsor's protocol ID
- STUDY00008372
- Other IDs
- 1R34CA304678-01A1
- Acronym
- CHEF
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility Study of a Dyadic Culinary Nutrition Intervention
- ClinicalTrials.gov ID
- NCT07702864
- Acronym / sponsor ID
- CHEF / STUDY00008372
- Conditions
- Neoplams, Prostate Cancer (Adenocarcinoma), Cancer Survivors, Caregiver Burden, Nutrition Therapy
- Keywords
- Cancer survivorship, Caregivers, Hispanic, Men's Health, Nutrition, Pilot study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Cooking Healthy - Engaging Families (CHEF)Dyadic culinary nutrition program |
| Education Control | Active comparator | Behavioral: ControlNutrition education |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention |
| ControlParticipants will receive written nutrition education developed for cancer survivors aligned with dietary recommendations. | Behavioural | Education Control |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
Fruit and Vegetable Servings
Time frame: Baseline, 12 weeks, 24 weeks
Concentration of Carotenoid Biomarkers
Time frame: Baseline, 12 weeks, 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meghan Skiba, PhD, MS, MPH, RDN principal investigator
University of Arizona Mel and Enid Zuckerman College of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooking Healthy - Engaging Families (CHEF) in people with Neoplams and Prostate Cancer (Adenocarcinoma), run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marjorie Nelson (520-626-3762, marjorienelson@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility measured by enrollment rate (time frame: Up to 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.