- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02191982
The Effect of Walking on Fatigue After Chemotherapy in Patients 65 and Older (S-PACT)
A Randomized, Wait-list Controlled Clinical Trial: the Effect of a Physical Activity Program on Fatigue After Potentially Curative Chemotherapy Among Cancer Survivors Age 65 or Older -- PACT (Physical Activity After Chemotherapy)
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599
- University of North Carolina
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Men and women age 65 years and older
- Histologically or cytologically confirmed cancer (hematologic or solid) at stage considered amenable to cure as assessed by the treating MD
Within 6 weeks of end of chemotherapy (all participants must have had chemotherapy treatment)
- Any radiation received must also be completed prior to randomization (if radiation treatment follows adjuvant chemotherapy, then the patient must be recruited within 6 weeks of end of radiation)
- Maintenance hormonal therapy in women with breast cancer is allowed; see exclusion criteria regarding hormonal therapy in males with prostate cancer
- Moderate to severe fatigue (>4 on BFI)
- Less than 120 minutes/week of physical activity
- English speaking
- Signed IRB approved written informed consent
- Approval from their treating physician to engage in moderate-intensity physical activity
- Patient-assessed ability to walk and engage in moderate physical activity
- Willing and able to meet all study requirements.
Exclusion Criteria:
- Receiving hormonal therapy for prostate cancer
- Unable to walk or engage in moderate-intensity physical activity
- Have BFI≤3.
- Report more than 120 minutes/week of physical activity
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Intervention
This arm will begin the Walk With Ease program after the completion of chemotherapy.
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Walk With Ease는 관절염 재단의 피로와 통증 완화에 도움이 되는 증거 기반 보행 개입입니다.
중재는 일주일에 5일, 하루 30분 동안 걷는 것을 궁극적인 목표로 참가자들을 안전하고 편안한 보행 프로그램으로 안내하는 자기주도 프로그램입니다.
다른 이름들:
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활성 비교기: Wait List Control
The arm will begin the Walk With Ease program three months after completion of chemotherapy.
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Walk With Ease는 관절염 재단의 피로와 통증 완화에 도움이 되는 증거 기반 보행 개입입니다.
중재는 일주일에 5일, 하루 30분 동안 걷는 것을 궁극적인 목표로 참가자들을 안전하고 편안한 보행 프로그램으로 안내하는 자기주도 프로그램입니다.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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To measure change in fatigue scores between intervention and wait list control arms from baseline to three months.
기간: Three months
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Change in fatigue will be measured using the FACIT-F.
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Three months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
To measure change in fatigue scores between intervention and WLC arms from baseline to 3 months
기간: Three months
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This outcome will be measured by the Brief Fatigue Inventory
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Three months
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To report recruitment and retention in the study at 3 months
기간: Three months
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Three months
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To report recruitment and retention in the study at 6 months
기간: Six months
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Six months
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To measure implementation of and adherence to WWE
기간: Six months
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Six months
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To count the number of adverse events
기간: Six months
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To characterize the safety of the walking program through a review of the number and type of adverse events, including falls, reported by study participants to the Study Team.
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Six months
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To measure change in engagement of walking over time from baseline to three months.
기간: Three Months
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To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms. Engagement in walking (total minutes per week) as measured by engagement in physical activity questions |
Three Months
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To measure change in physical function over time from baseline to three months.
기간: Three Months
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To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms. Physical function as measured by SPPB |
Three Months
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To measure change in quality of life over time from baseline to three months.
기간: Three Months
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To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms. Quality of life as measured by FACT-G (global and subscales) and symptom scales, including PROMIS pain intensity, sleep disturbance and depression. |
Three Months
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To measure change in self-efficacy over time from baseline to three months.
기간: Three Months
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To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms. Engagement in walking (total minutes per week) as measured by engagement in physical activity questions |
Three Months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Hyman B Muss, MD, UNC Lineberger Comprehensive Cancer Center
간행물 및 유용한 링크
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. .
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