NCT03177759

Brief Summary

This is a prospective evaluation to determine the effectiveness of the Prostate Cancer Supportive Care (PCSC) Program's group therapy program, Living with Prostate Cancer (LPC). LPC is an intervention which utilizes a small group format (5-7 participants with 2 leaders and a paraprofessional counselling student) to understand and learn how to manage emotional responses, depressive symptoms, and life stressors associated with prostate cancer. Data for this evaluation will be derived from a focus group (at 3 months) and self-report questionnaires that participants will complete immediately prior to the intervention, immediately following the intervention and at 3, 6, and 12-months post-intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

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

September 9, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

October 2, 2019

Status Verified

October 1, 2019

Enrollment Period

2.8 years

First QC Date

March 7, 2017

Last Update Submit

October 1, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in depressive and anxiety symptoms

    Measured by the Beck Depression Inventory

    Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months

Secondary Outcomes (5)

  • Changes in overall well-being

    Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months

  • Changes in perceptions of masculinity

    Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months

  • Changes in perceptions of masculinity

    Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months

  • Group cohesion and dynamics

    3-Weeks (Post-workshop), 3-, 6- and 12 Months

  • Patient-incurred costs for attending the session

    3-Weeks (Post-Workshop)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The LPC Workshops will only include men with a diagnosis of Prostate Cancer Stages 1 to 3.

You may qualify if:

  • Men are eligible to participate in this evaluation if they:
  • are older than 18 years old
  • are willing to attend the "Living with Prostate Cancer" group therapy sessions from the PCSC Program\*
  • are able to speak and read English such that they are able to understand the questionnaires
  • have unimpaired cognitive function with an ability to understand the nature of the study
  • are willing to complete questionnaires at 5 time points
  • provide written informed consent
  • to be able to participate in LPC groups, men must have recently received a diagnosis of PC Stages 1 to 3, or have recently been recommended to undergo a form of treatment following a period of active surveillance.

You may not qualify if:

  • Men will be ineligible to participate in this evaluation if they:
  • have difficulties reading or understanding English
  • have psychotic symptoms, current severe alcohol or other drug dependence, unwillingness to refrain from substance use during the program, and/or significant cognitive impairment that would prevent them participating or providing full informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver Prostate Centre

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • David Kuhl, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2017

First Posted

June 6, 2017

Study Start

September 9, 2016

Primary Completion

June 30, 2019

Study Completion

August 31, 2019

Last Updated

October 2, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations