Prostate Cancer Clinical Trial
Official title:
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.
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.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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