Pilot Feasibility Study of a Dyadic Culinary Nutrition Intervention (CHEF)
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Marjorie Nelson
- Telefonnummer: 520-626-3762
- E-mail: marjorienelson@arizona.edu
Studiesteder
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Arizona
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Tucson, Arizona, Forenede Stater, 85719
- Arizona Cancer Center at UMC North/University Medical Center
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Kontakt:
- Meghan Skiba, PhD, MS, MPH, RDN
- Telefonnummer: 520-621-9036
- E-mail: mbskiba@arizona.edu
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Intervention
Dyadic culinary nutrition program
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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.
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Aktiv komparator: Education Control
Nutrition education
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Participants will receive written nutrition education developed for cancer survivors aligned with dietary recommendations.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Feasibility measured by enrollment rate
Tidsramme: Up to 12 weeks
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Will be determined as the enrollment rate- the number of dyads enrolled out of those approached and eligible using descriptive statistics.
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Up to 12 weeks
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Appropriateness measured by retention rate
Tidsramme: Up to 24 weeks
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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.
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Up to 24 weeks
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Acceptability measured by adherence rate
Tidsramme: Up to 12 weeks
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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.
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Up to 12 weeks
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Composite measure of implementation success
Tidsramme: 12 weeks
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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.
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12 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Fruit and Vegetable Servings
Tidsramme: Baseline, 12 weeks, 24 weeks
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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.
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Baseline, 12 weeks, 24 weeks
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Concentration of Carotenoid Biomarkers
Tidsramme: Baseline, 12 weeks, 24 weeks
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Carotenoids (beta-carotene, lutein, zeaxanthin, and lycopene) will be analyzed using blood samples obtained using a self-administered dried blood spot (DBS) collection.
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Baseline, 12 weeks, 24 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Meghan Skiba, PhD, MS, MPH, RDN, University of Arizona Mel and Enid Zuckerman College of Public Health
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Genitale sygdomme
- Genitale neoplasmer, mandlige
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Neoplasmer
- Kønssygdomme, mandlige
- Prostatasygdomme
- Mandlige urogenitale sygdomme
- Adfærdsmæssige symptomer
- Neoplasmer efter histologisk type
- Neoplasmer, kirtel og epitel
- Karcinom
- Stress, psykologisk
- Opførsel
- Plejerbyrde
- Prostatiske neoplasmer
- Adenocarcinom
Andre undersøgelses-id-numre
- STUDY00008372
- 1R34CA304678-01A1 (Andet bevillings-/finansieringsnummer: NCI)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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