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Completed

NCT Number: NCT02954289

Cooking Class Intervention Project for Men With Prostate Cancer and Their Partners

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia

Vancouver, British Columbia, V6T1Z3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary intervention

Behavioral

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

Other names: Cooking classes

Primary outcomes

  1. Feasibility of the intervention as measured through study accrual

    Time frame: up to six weeks per session

  2. Feasibility of the intervention as measured through participant adherence

    Time frame: up to six weeks per session

  3. Feasibility of the intervention as measured through participant retention

    Time frame: up to 6 weeks per session

  4. Feasibility of the intervention as measured through participant satisfaction interviews

    Time frame: 3-months post intervention

Secondary outcomes

  1. Change in anthropometric measures (height, weight, hip and waist)

    Time frame: Baseline and 6 weeks

  2. Change in relationship quality measured by the 15-item Mutuality Scale

    Time frame: Baseline and six weeks

  3. Change in dietary outcome using a modified version of the National Institutes of Health Quick Food Scan

    Time frame: Baseline and 6 weeks

  4. Change in quality of life using the 12-Item Short Form Health Survey

    Time frame: Baseline and six weeks

  5. Change in quality of life using the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q)

    Time frame: Baseline and 6 weeks

  6. Change in relationship using the Relationship Assessment Scale

    Time frame: Baseline and 6 weeks

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Canadian Cancer Society (CCS)

Registry information

Official study title

Increasing Healthy Outcomes for Prostate Cancer Survivors: An Innovative Cooking Class Intervention Pilot Study

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 3, 2016
Registry last updated
Nov 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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