Clinical trial NCT02954289: Cooking Class Intervention Project for Men With Prostate Cancer and Their Partners
Official title: Increasing Healthy Outcomes for Prostate Cancer Survivors: An Innovative Cooking Class Intervention Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: modifiable risk factors
lifestyle
nutrition
weight control
dietary intervention
health promotion
patient-partner outcomes
survivorship
prostate cancer outcomes
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Society (CCS)
First posted: 2016-11-03
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of the intervention as measured through study accrual
timeFrame: up to six weeks per session
measure: Feasibility of the intervention as measured through participant adherence
timeFrame: up to six weeks per session
measure: Feasibility of the intervention as measured through participant retention
timeFrame: up to 6 weeks per session
measure: Feasibility of the intervention as measured through participant satisfaction interviews
timeFrame: 3-months post intervention
Secondary outcomes:
measure: Change in anthropometric measures (height, weight, hip and waist)
timeFrame: Baseline and 6 weeks
measure: Change in relationship quality measured by the 15-item Mutuality Scale
timeFrame: Baseline and six weeks
measure: Change in dietary outcome using a modified version of the National Institutes of Health Quick Food Scan
timeFrame: Baseline and 6 weeks
measure: Change in quality of life using the 12-Item Short Form Health Survey
timeFrame: Baseline and six weeks
measure: Change in quality of life using the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q)
timeFrame: Baseline and 6 weeks
measure: Change in relationship using the Relationship Assessment Scale
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Carolyn Gotay, PhD
role: PRINCIPAL_INVESTIGATOR
References: