- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03177759
Living With Prostate Cancer (LPC) (LPC)
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
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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British Columbia
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Vancouver, British Columbia, 캐나다, V5Z 1M9
- Vancouver Prostate Centre
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in depressive and anxiety symptoms
기간: Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months
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Measured by the Beck Depression Inventory
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Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Changes in overall well-being
기간: Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months
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Measured by the Warwick-Edinburgh Mental Wellbeing Scale
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Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months
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Changes in perceptions of masculinity
기간: Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months
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Measured by the Personal Attributes Questionnaire
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Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months
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Changes in perceptions of masculinity
기간: Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months
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Measured by the Masculine Behaviour Scale
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Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months
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Group cohesion and dynamics
기간: 3-Weeks (Post-workshop), 3-, 6- and 12 Months
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Measured by the Group Questionnaire
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3-Weeks (Post-workshop), 3-, 6- and 12 Months
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Patient-incurred costs for attending the session
기간: 3-Weeks (Post-Workshop)
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Measured by an annotated cost questionnaire for completion by patients
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3-Weeks (Post-Workshop)
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공동 작업자 및 조사자
수사관
- 수석 연구원: David Kuhl, MD, University of British Columbia
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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