- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02729883
Take the Fight in Supporting and Empowering Patients With Cancer
A Pilot Study of 'Take the Fight' as Community-Based Participatory Research
연구 개요
상세 설명
PRIMARY OBJECTIVES:
I. Delineate the benefits of and limitations to having Take the Fight strategists, performing as lay-navigators, as perceived by both the patients and the students.
SECONDARY OBJECTIVES:
I. Investigate changes in self-reported outcomes for patients and the Take the Fight strategists.
OUTLINE:
Patients receive patient navigation via strategists from the Take the Fight for 8 weeks. Patients also complete interviews regarding perceived physical, logistical, psychosocial, and informational challenges experienced prior to meeting with strategists/navigators and how challenges were addressed by navigator or others, perceived benefits or limitations of navigator assistance. Strategists also complete interviews regarding their perceptions on how patients benefited from participation, challenges patients experienced that were directly or indirectly related to their cancer diagnosis and treatment, how these concerns were addressed, barriers to addressing these concerns, and patient health literacy.
After completion of study, patients and strategists are followed up for 8-10 weeks.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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North Carolina
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Winston-Salem, North Carolina, 미국, 27157
- Comprehensive Cancer Center of Wake Forest University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- PATIENTS ELIGIBILITY CRITERIA
- Have histologically confirmed cancer
- Karnofsky performance scale (KPS) score of >= 60
- The ability to understand and be willing to sign an informed consent document
- Willing to undergo a form of cancer therapy and subsequent follow-up care
- STRATEGISTS INCLUSION CRITERIA
- Age >= 18 years
- Wake Forest University student
- Have volunteered as a student strategist at Comprehensive Cancer Center of Wake Forest University (CCCWFU); all strategists are required to have gone through Take the Fight (TTF) training prior to their volunteer work
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Supportive care (Take the Fight)
Patients receive patient navigation via strategists from the Take the Fight for 8 weeks.
Patients also complete interviews regarding perceived physical, logistical, psychosocial, and informational challenges experienced prior to meeting with strategists/navigators and how challenges were addressed by navigator or others, perceived benefits or limitations of navigator assistance.
Strategists also complete interviews regarding their perceptions on how patients benefited from participation, challenges patients experienced that were directly or indirectly related to their cancer diagnosis and treatment, how these concerns were addressed, barriers to addressing these concerns, and patient health literacy.
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보조 연구
다른 이름들:
Complete interviews
Receive patient navigation via the Take the Fight strategists
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in patients self-reported outcomes using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life-Cancer 30 (QLQ-C30) questionnaire
기간: Baseline to up to 18 weeks
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Descriptive statistics will be measured, including frequencies, percentages, means and standard deviations of patient self-report measures will be calculated.
Ninety-five percent confidence intervals will also be calculated for the outcomes measures at each time point.
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Baseline to up to 18 weeks
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Change in strategists self-reported outcomes using Caregiver Quality of Life Index-Cancer (CQOLC, McMillian, 1996) scale
기간: Baseline to up to 10 weeks
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Baseline to up to 10 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Stefan Grant, Wake Forest University Health Sciences
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 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IRB00037093
- P30CA012197 (미국 NIH 보조금/계약)
- NCI-2016-00384 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
- CCCWFU 99216 (기타 식별자: Comprehensive Cancer Center of Wake Forest University)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
삶의 질 평가에 대한 임상 시험
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Memorial Sloan Kettering Cancer Center종료됨
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Rostyslav Voloshchuk아직 모집하지 않음전신 마취 | 확인 | 수술 후 회복 | 설문지