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Living With Prostate Cancer (LPC) (LPC)

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ClinicalTrials.gov Identifier: NCT03177759
Recruitment Status : Recruiting
First Posted : June 6, 2017
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Vancouver Prostate Centre

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.

Condition or disease
Prostate Cancer

Detailed Description:

The Vancouver Prostate Centre's (VPCs) PCSC Program is designed to address the gap in supportive care for men with prostate cancer (PC), their partners and their families. The evaluation protocol described here is specific to the program called "Living with Prostate Cancer" (LPC) from the Psychooncology module of the PCSC Program. The specific rationale for this module is that many cancer patients will experience significant anxiety or depression at some point along their cancer journey. The module includes private, confidential clinic appointments for PC patients and their spouses/partners, either separately or together, with our registered clinical counsellor, to explore how to cope with difficult emotions such as fear, anxiety, sadness, helplessness, and other signs of emotional distress. The module is now being expanded to include small group discussions. LPC is a group therapy program in which men participate in a guided autobiographical life review through a process that focuses on developing a cohesive working group, learning strategic communication skills, and understanding and learning how to manage difficult emotions and transitional life stressors associated with PC. It also focuses on the processing and integrating of critical events that contribute to the men's present day identity and psychological function and involves the consolidation of the personal learning that occurs. It shifts the focus on transitioning into the future by developing specific individual, family and/or career goals that are reinforced by ongoing support from peers in the group. Finally, post-group referral plans are developed on an individual basis as needed.

The group therapy program includes men with a diagnosis of PC Stages 1 to 3. We will administer validated quantitative tools to assess depression and anxiety, general psychological functioning, and male role norms (masculinity) before, after, and at 3, 6, and 12-months following the program. The meeting 3 months after the program will include a focus group process.


Study Type : Observational
Estimated Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluating a Group Therapy Intervention to Alleviate Psychological Distress in Men With Prostate Cancer: An Assessment of a Group Therapy Program From Vancouver's Prostate Cancer Supportive Care (PCSC) Program
Actual Study Start Date : September 9, 2016
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer




Primary Outcome Measures :
  1. Changes in depressive and anxiety symptoms [ Time Frame: Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months ]
    Measured by the Beck Depression Inventory


Secondary Outcome Measures :
  1. Changes in overall well-being [ Time Frame: Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months ]
    Measured by the Warwick-Edinburgh Mental Wellbeing Scale

  2. Changes in perceptions of masculinity [ Time Frame: Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months ]
    Measured by the Personal Attributes Questionnaire

  3. Changes in perceptions of masculinity [ Time Frame: Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months ]
    Measured by the Masculine Behaviour Scale

  4. Group cohesion and dynamics [ Time Frame: 3-Weeks (Post-workshop), 3-, 6- and 12 Months ]
    Measured by the Group Questionnaire

  5. Patient-incurred costs for attending the session [ Time Frame: 3-Weeks (Post-Workshop) ]
    Measured by an annotated cost questionnaire for completion by patients



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The LPC Workshops will only include men with a diagnosis of Prostate Cancer Stages 1 to 3.
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

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): NCT03177759


Contacts
Contact: Phil Pollock, MRes 604-875-4111 ext 22946 ppollock@prostatecentre.com

Locations
Canada, British Columbia
Vancouver Prostate Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Phil Pollock, MRes    604-875-4111 ext 22946    ppollock@prostatecentre.com   
Principal Investigator: David Kuhl, MD         
Sponsors and Collaborators
Vancouver Prostate Centre
Investigators
Principal Investigator: David Kuhl, MD University of British Columbia

Responsible Party: Vancouver Prostate Centre
ClinicalTrials.gov Identifier: NCT03177759     History of Changes
Other Study ID Numbers: PCSC-6
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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