Clinical trial NCT03177759: Living With Prostate Cancer (LPC)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Vancouver Prostate Centre
Sponsor class: OTHER
First posted: 2017-06-06
Enrollment: 42
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The LPC Workshops will only include men with a diagnosis of Prostate Cancer Stages 1 to 3.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Changes in depressive and anxiety symptoms
timeFrame: Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months
Secondary outcomes:
measure: Changes in overall well-being
timeFrame: Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months
measure: Changes in perceptions of masculinity
timeFrame: Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months
measure: Changes in perceptions of masculinity
timeFrame: Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months
measure: Group cohesion and dynamics
timeFrame: 3-Weeks (Post-workshop), 3-, 6- and 12 Months
measure: Patient-incurred costs for attending the session
timeFrame: 3-Weeks (Post-Workshop)
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver Prostate Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: David Kuhl, MD
role: PRINCIPAL_INVESTIGATOR
References: