NCT02954289

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2016

Completed
Last Updated

November 4, 2016

Status Verified

November 1, 2016

Enrollment Period

2.6 years

First QC Date

November 1, 2016

Last Update Submit

November 3, 2016

Conditions

Prostate Cancer

Keywords

modifiable risk factorslifestylenutritionweight controldietary interventionhealth promotionpatient-partner outcomessurvivorshipprostate cancer outcomes

Outcome Measures

Primary Outcomes (4)

  • Feasibility of the intervention as measured through study accrual

    up to six weeks per session

  • Feasibility of the intervention as measured through participant adherence

    up to six weeks per session

  • Feasibility of the intervention as measured through participant retention

    up to 6 weeks per session

  • Feasibility of the intervention as measured through participant satisfaction interviews

    3-months post intervention

Secondary Outcomes (6)

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

    Baseline and 6 weeks

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

    Baseline and six weeks

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

    Baseline and 6 weeks

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

    Baseline and six weeks

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

    Baseline and 6 weeks

  • +1 more secondary outcomes

Study Arms (1)

Dietary intervention

OTHER

Dietary intervention

Behavioral: Dietary intervention

Interventions

Dietary interventionBEHAVIORAL

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

Also known as: Cooking classes
Dietary intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A man
  • Have a diagnosis of prostate cancer
  • 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

You may not qualify if:

  • Are on a strict diet, such as gluten-free diet
  • 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
  • Are on a strict diet, such as gluten-free diet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T1Z3, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Carolyn Gotay, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 1, 2016

First Posted

November 3, 2016

Study Start

February 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

November 4, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)