- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02085096
Problem Solving Therapy for Prostate Cancer Spousal Caregivers
Problem-Solving Therapy for Prostate Cancer Patient's Spousal Caregivers
연구 개요
상세 설명
Problem-solving therapy programs have been shown to be effective among parents of children diagnosed with cancer. Efforts have been made to apply this same strategy to spouses/significant others of men diagnosed with prostate cancer. The purpose of this study is to test the efficacy of problem-solving therapy on the spouses of prostate cancer patients.
Participants were randomly assigned to an experimental group which received problem-solving therapy, or to a control group which relied on their standard methods of coping (e.g. their normal therapist, family and friends).
Participants completed baseline surveys regarding their distress and coping prior to randomization. They then completed these surveys again at post-intervention (approximately 2-3 months post-baseline) and 6 months post-baseline to determine lasting effects of the intervention.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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La Jolla, California, 미국, 92093
- UC San Diego Moores Cancer Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Diagnosed with prostate cancer within 18 months of study enrollment.
- The patient and significant other cohabited
- Couples resided in San Diego County
- Both patient and significant other were sufficiently proficient in English
Exclusion Criteria:
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공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Problem-Solving Therapy
A problem-solving therapy training program will be provided to the spouses/significant others of men diagnosed with prostate cancer.
The purpose of this study is to test the efficacy of problem-solving therapy on the spouses of prostate cancer patients.
|
Problem-solving therapy programs have been shown to be effective among parents of children diagnosed with cancer.
Efforts have been made to apply this same strategy to spouses/significant others of men diagnosed with prostate cancer.
The purpose of this study is to test the efficacy of problem-solving therapy on the spouses of prostate cancer patients.
|
|
위약 비교기: Standard Supportive Care
Participants who are randomized to this arm will be encouraged to use whatever supporting care is recommended to them by their health provider.
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Problem-solving therapy programs have been shown to be effective among parents of children diagnosed with cancer.
Efforts have been made to apply this same strategy to spouses/significant others of men diagnosed with prostate cancer.
The purpose of this study is to test the efficacy of problem-solving therapy on the spouses of prostate cancer patients.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Change from Baseline of Effects of Stress and Coping to Follow-ups
기간: From baseline to follow-ups at post-intervention (2-3 months post-baseline) and 6-months post-baseline
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From baseline to follow-ups at post-intervention (2-3 months post-baseline) and 6-months post-baseline
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공동 작업자 및 조사자
수사관
- 수석 연구원: Georgia R Sadler, PhD, UC San Diego Moores Cancer Center
- 수석 연구원: Vanessa L Malcarne, PhD, San Diego State University
간행물 및 유용한 링크
일반 간행물
- Banthia R, Malcarne VL, Varni JW, Ko CM, Sadler GR, Greenbergs HL. The effects of dyadic strength and coping styles on psychological distress in couples faced with prostate cancer. J Behav Med. 2003 Feb;26(1):31-52. doi: 10.1023/a:1021743005541.
- Ko CM, Malcarne VL, Varni JW, Roesch SC, Banthia R, Greenbergs HL, Sadler GR. Problem-solving and distress in prostate cancer patients and their spousal caregivers. Support Care Cancer. 2005 Jun;13(6):367-74. doi: 10.1007/s00520-004-0748-5. Epub 2005 Jan 19.
- Hawes S, Malcarne V, Ko C, Sadler G, Banthuia R, Sherman S, Varni J, Schmidt J. Identifying problems faced by spouses and partners of patients with prostate cancer. Oncol Nurs Forum. 2006 Jul 1;33(4):807-14. doi: 10.1188/06.ONF.807-814.
- Yoshimoto SM, Ghorbani S, Baer JM, Cheng KW, Banthia R, Malcarne VL, Sadler GR, Ko CM, Greenbergs HL, Varni JW. Religious coping and problem-solving by couples faced with prostate cancer. Eur J Cancer Care (Engl). 2006 Dec;15(5):481-8. doi: 10.1111/j.1365-2354.2006.00700.x.
- Merz EL, Malcarne VL, Ko CM, Sadler M, Kwack L, Varni JW, Sadler GR. Dyadic concordance among prostate cancer patients and their partners and health-related quality of life: does it matter? Psychol Health. 2011 Jun;26(6):651-66. doi: 10.1080/08870441003721251. Epub 2011 Jul 11.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
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. .