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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dietary intervention
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostate Cancer focused on measuring modifiable risk factors, lifestyle, nutrition, weight control, dietary intervention, health promotion, patient-partner outcomes, survivorship, prostate cancer outcomes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of British Columbia

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Dietary intervention

Arm Description

Dietary intervention

Outcomes

Primary Outcome Measures

Feasibility of the intervention as measured through study accrual
Feasibility of the intervention as measured through participant adherence
Feasibility of the intervention as measured through participant retention
Feasibility of the intervention as measured through participant satisfaction interviews

Secondary Outcome Measures

Change in anthropometric measures (height, weight, hip and waist)
Change in relationship quality measured by the 15-item Mutuality Scale
Change in dietary outcome using a modified version of the National Institutes of Health Quick Food Scan
Change in quality of life using the 12-Item Short Form Health Survey
Change in quality of life using the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q)
Change in relationship using the Relationship Assessment Scale

Full Information

First Posted
November 1, 2016
Last Updated
November 3, 2016
Sponsor
University of British Columbia
Collaborators
Canadian Cancer Society (CCS)
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1. Study Identification

Unique Protocol Identification Number
NCT02954289
Brief Title
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

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Canadian Cancer Society (CCS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
modifiable risk factors, lifestyle, nutrition, weight control, dietary intervention, health promotion, patient-partner outcomes, survivorship, prostate cancer outcomes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dietary intervention
Arm Type
Other
Arm Description
Dietary intervention
Intervention Type
Behavioral
Intervention Name(s)
Dietary intervention
Other Intervention Name(s)
Cooking classes
Intervention Description
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
Primary Outcome Measure Information:
Title
Feasibility of the intervention as measured through study accrual
Time Frame
up to six weeks per session
Title
Feasibility of the intervention as measured through participant adherence
Time Frame
up to six weeks per session
Title
Feasibility of the intervention as measured through participant retention
Time Frame
up to 6 weeks per session
Title
Feasibility of the intervention as measured through participant satisfaction interviews
Time Frame
3-months post intervention
Secondary Outcome Measure Information:
Title
Change in anthropometric measures (height, weight, hip and waist)
Time Frame
Baseline and 6 weeks
Title
Change in relationship quality measured by the 15-item Mutuality Scale
Time Frame
Baseline and six weeks
Title
Change in dietary outcome using a modified version of the National Institutes of Health Quick Food Scan
Time Frame
Baseline and 6 weeks
Title
Change in quality of life using the 12-Item Short Form Health Survey
Time Frame
Baseline and six weeks
Title
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
Title
Change in relationship using the Relationship Assessment Scale
Time Frame
Baseline and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn Gotay, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T1Z3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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