- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02954289
Cooking Class Intervention Project for Men With Prostate Cancer and Their Partners
Increasing Healthy Outcomes for Prostate Cancer Survivors: An Innovative Cooking Class Intervention Pilot Study
Prostate cancer is one of the most commonly diagnosed cancers in Canada, with 24,000 new cases estimated for 2015. Prostate cancer patients often live with uncomfortable side effects of treatment, such as a decrease in bone health, weight gain, and challenges to their interpersonal relationships. Nutrition can improve outcomes for PCa survivors; however, dietary interventions for prostate cancer patients are limited. Therefore, this is a feasibility study that tests the impact of an innovative intervention to promote healthy nutrition and weight control for prostate cancer survivors and their partners.
The objectives are to assess the feasibility of the intervention, specifically:
- Accrual, retention and adherence, and participant satisfaction
- Candidate measures for primary outcomes in future studies
The intent is to evaluate how well the classes work and identify ways to make them more successful. At the end of the study, the investigators will know if this approach shows merit to be tested further through a randomized controlled trial.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Prostate cancer (PCa) is the most commonly-diagnosed invasive cancer in Canada, with 24,000 new cases predicted for 2015. The large majority of men (96%) will survive five or more years post-diagnosis. However, many PCa survivors live with side effects of the disease and treatment and may develop chronic conditions due to aging and/or cancer therapy. The PCa-related side effects can also impact men's interpersonal relationships. Effective interventions to promote health and well-being for PCa survivors are urgently needed.
Evidence shows that nutrition can improve outcomes for PCa survivors; however, dietary interventions for prostate cancer patients are limited. Furthermore, all PCa-related interventions reported thus far are limited in one important way: they focus only on the patient/survivor. Yet, the impact of prostate cancer extends to the spouse as well. When it comes to lifestyle interventions, responsibility for health behaviours and food preparation typically falls on the wife, particularly in today's cohort of PCa patients. As such, engaging the partner is crucial to ensure success for the survivor, and provide benefits for the wife as well.
Therefore, this is a feasibility study that tests the impact of an innovative intervention to promote healthy nutrition and weight control for PCa survivors and their partners.
The objectives are to assess the feasibility of the intervention, specifically:
- Accrual, retention and adherence, and participant satisfaction
- Candidate measures for primary outcomes in future studies
The study draws on Interdependence Theory and features of successful cooking class intervention research in other populations. Specifically, it uses hands-on cooking experience, combined with increased cooking skills and nutrition knowledge to build skills and self-efficacy; to be culturally appropriate and use simple affordable ingredients; and to involve the spouses.
The dietary intervention will be offered to a total of 24 couples (48 individuals). The intervention includes 6 cooking and nutrition-related classes, that are held weekly in a university classroom kitchen with interactive demo and cooking components. Classes focus on learning through preparing theme-based recipes, with themes organized around prostate health.
Feasibility outcomes are assessed throughout. Questionnaire-based outcomes are assessed pre- and post-intervention, anthropometric outcomes at first and last intervention session.
The main intent is to evaluate how well the classes work and identify ways to make them more successful. At the end of the study, the investigators will know if this approach shows merit to be tested further through a randomized controlled trial.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6T1Z3
- University of British Columbia
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria for Men with Prostate Cancer:
- A man
- Have a diagnosis of prostate cancer
- 18 years or older
- Are living with a wife or common-law partner
- Can read and understand English
- Have a desire to participate in a cooking class study with wife/partner
Exclusion Criteria for Men with Prostate Cancer:
• Are on a strict diet, such as gluten-free diet
Inclusion Criteria for Partners:
- Are a female
- Are living with a husband or common-law partner who has been diagnosed with prostate cancer
- Are 18 years or older
- Can read and understand English
- Have a desire to participate in a cooking class study with husband/partner
Exclusion Criteria for Partners:
• Are on a strict diet, such as gluten-free diet
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: Dietary intervention
|
Session 1:The Breakfast Club: ways to increase the healthiness of breakfast and all meals. Session 2: Calcium and Vitamin D -Keys to Bone Health Session 3: Fruits and Veggies -Your New Best Friends Session 4: Let's Talk About Fat Session 5: Shopping Therapy Session 6: Celebrity Chefs Share Their Secrets
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Feasibility of the intervention as measured through study accrual
Tidsramme: up to six weeks per session
|
up to six weeks per session
|
Feasibility of the intervention as measured through participant adherence
Tidsramme: up to six weeks per session
|
up to six weeks per session
|
Feasibility of the intervention as measured through participant retention
Tidsramme: up to 6 weeks per session
|
up to 6 weeks per session
|
Feasibility of the intervention as measured through participant satisfaction interviews
Tidsramme: 3-months post intervention
|
3-months post intervention
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in anthropometric measures (height, weight, hip and waist)
Tidsramme: Baseline and 6 weeks
|
Baseline and 6 weeks
|
Change in relationship quality measured by the 15-item Mutuality Scale
Tidsramme: Baseline and six weeks
|
Baseline and six weeks
|
Change in dietary outcome using a modified version of the National Institutes of Health Quick Food Scan
Tidsramme: Baseline and 6 weeks
|
Baseline and 6 weeks
|
Change in quality of life using the 12-Item Short Form Health Survey
Tidsramme: Baseline and six weeks
|
Baseline and six weeks
|
Change in quality of life using the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q)
Tidsramme: Baseline and 6 weeks
|
Baseline and 6 weeks
|
Change in relationship using the Relationship Assessment Scale
Tidsramme: Baseline and 6 weeks
|
Baseline and 6 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Carolyn Gotay, PhD, University of British Columbia
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 702413
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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