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Trial record 38 of 4738 for:    British | Canada

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

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ClinicalTrials.gov Identifier: NCT02954289
Recruitment Status : Completed
First Posted : November 3, 2016
Last Update Posted : November 4, 2016
Sponsor:
Collaborator:
Canadian Cancer Society Research Institute (CCSRI)
Information provided by (Responsible Party):
Carolyn Gotay, University of British Columbia

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: Dietary intervention Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Increasing Healthy Outcomes for Prostate Cancer Survivors: An Innovative Cooking Class Intervention Pilot Study
Study Start Date : February 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Dietary intervention
Dietary intervention
Behavioral: 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

Other Name: Cooking classes




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02954289


Locations
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V6T1Z3
Sponsors and Collaborators
University of British Columbia
Canadian Cancer Society Research Institute (CCSRI)
Investigators
Principal Investigator: Carolyn Gotay, PhD University of British Columbia

Responsible Party: Carolyn Gotay, Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT02954289     History of Changes
Other Study ID Numbers: 702413
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Carolyn Gotay, University of British Columbia:
modifiable risk factors
lifestyle
nutrition
weight control
dietary intervention
health promotion
patient-partner outcomes
survivorship
prostate cancer outcomes

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases