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临床试验/NCT03177759
NCT03177759已完成不适用

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

Vancouver Prostate Centre1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2016年9月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
1
主要终点
Changes in depressive and anxiety symptoms

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Changes in depressive and anxiety symptoms

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

Measured by the Beck Depression Inventory

次要结局

  • 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)
  • Group cohesion and dynamics(3-Weeks (Post-workshop), 3-, 6- and 12 Months)
  • Patient-incurred costs for attending the session(3-Weeks (Post-Workshop))

研究者

发起方
Vancouver Prostate Centre
申办方类型
Other
责任方
Sponsor

研究点 (1)

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