- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01716702
A Feasibility Study of an Online Intervention for Sexual Rehabilitation in Prostate Cancer
Background: Prostate cancer (PCa) is the most common cancer for men. When treated early enough it is typically curable. However, common treatments, such as radical prostatectomy and radiation therapy, often result in significant negative outcomes with regard to sexual, psychological and social function. Both men and partners have identified the need for more information and support to address sexual health concerns after treatment. However, very few sexual rehabilitation interventions have been developed and rigorously assessed.
Purpose: The investigators propose to develop and pilot test a new program to meet the sexual health needs of men with PCa and their partners using an online, professionally facilitated education/support program. The goals of the program are to improve sexual function, intimacy and mood for men and their partners after treatment for localized PCa. The program will be offered through Cancer Chat Canada, an existing and well-tested Canadian platform for professionally facilitated support group programs.
What Participants Can Expect: A total of 24 men and their female partners (48 individuals) will be recruited and assigned to one of two groups. The first group will participate in the program immediately; the second group will be offered the program after a 5-month delay. The decision about which group will start immediately and which later will be made randomly (by chance). Both groups of men and partners will be asked to complete questionnaires three times and, at the end of the program, to provide the researchers feedback about how satisfied they were with the program, the changes they made, things they learned as a result of the program, and suggestions for improving the program. Participants must have access to a computer, an Internet connection and be willing to attend online, chat room meetings each week for 1.5 hours for 6 weeks.
Implications: Sexual rehabilitation is a high need for men affected by PCa, but is difficult to access. The investigators hope to improve access to sexual health care through this study.
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Deborah L McLeod, R.N., Ph.D.
- 전화번호: 902-473-2964
- 이메일: DeborahL.McLeod@cdha.nshealth.ca
연구 장소
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Nova Scotia
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Halifax, Nova Scotia, 캐나다
- 모병
- Capital District
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연락하다:
- Deborah L McLeod
- 전화번호: 902-473-2964
- 이메일: DeborahL.McLeod@cdha.nshealth.ca
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수석 연구원:
- Deborah L McLeod, R.N., Ph.D.
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Men who have been treated for localized prostate cancer
- AND men must be 6-36 months post-prostatectomy or radiation (as primary treatment) of prostate cancer
- Must have a heterosexual, co-cohabiting partner who is willing to participate
- Must speak and read English
- Must be able to use a computer and have internet access
Exclusion Criteria:
- Homosexual couples will not be included in this study
- Major self-reported psychiatric illness
- Couples who screen below 30 on the DAS (Dyadic Adjustment Scale)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Couples Prostate Cancer Support Group
The participants in the support group will receive 6 weekly online intervention sessions with a professional facilitator. In addition participants will be asked to complete relationship-enhancement exercises and readings in between sessions. Participants will be asked to complete questionnaires at three time points: 1)pre-intervention (baseline) 2) post-intervention (7 weeks), and 3) post intervention (13 weeks). |
The participants in the experimental group will receive 6 weekly online intervention sessions with a professional facilitator. In addition participants will be asked to complete relationship-enhancement exercises and readings in between sessions. In the experimental group, participants will be asked to complete questionnaires at three time points: 1)pre-intervention (baseline) 2) post-intervention (7 weeks), and 3) post intervention (13 weeks). In the waitlist group, participants will not participate in the support group. Participants will be asked to complete questionnaires at three time points: 1)pre-intervention (baseline) 2) post-intervention (7 weeks), and 3) post intervention (13 weeks). |
간섭 없음: Wait-List Control
Participants will be asked to complete questionnaires at three time points: 1)week 1 2) week 7, and 3) week 13.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Change in Sexual Function from Baseline to 13 weeks
기간: Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)
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Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Change in Personal Assessment of Intimacy and Relationships from baseline to 13 weeks
기간: Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)
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Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in Profile of Mood States Short Form from baseline to 13 weeks
기간: Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)
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This tool assesses psychological distress across 6 domains: fatigue-inertia, vigor-activity, tension-anxiety, depression-dejection, anger-hostility, and confusion-bewilderment.
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Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Deborah L McLeod, R.N., Ph.D., Capital District Health Authority & Dalhousie University
- 수석 연구원: Richard J Wassersug, Ph.D., University of British Columbia
- 수석 연구원: Karen Fergus, Ph.D., C. Psych., Sunnybrook Odette Cancer Centre & York University
- 수석 연구원: John Robinson, Ph.D., C. Psych., Tom Baker Cancer Centre & University of Calgary
- 수석 연구원: John Oliffe, R.N, Ph.D., University of British Columbia
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CDHA-RS/2013-076
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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