Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy (PROACTIVE)
Breast cancer and its treatments can take a toll on the physical and psychosocial well-being of cancer survivors. Few interventions can help breast cancer patients improve their physical strength, stamina, and overall well-being. Developing ways to facilitate PA behavior during chemotherapy for breast cancer are necessary. This trial explores ways that breast cancer patients receiving chemotherapy can learn about and engage in PA during chemotherapy. This trial will also give Southern Alberta breast cancer survivors an opportunity to participate in evidence-based programs designed to facilitate their health, breast cancer recovery, and disease-free survival.
The investigators primary hypothesis is that women receiving the PA intervention resource kit will report a more positive change in self-reported PA at the end of chemotherapy treatments when compared to the group receiving standard materials.
연구 개요
상세 설명
Primary Objective:
To compare the effects of an evidence-based intervention consisting of targeted breast-cancer specific PA print materials (i.e., Exercise for health), a step pedometer, a step-walking guidebook (i.e., Step into survivorship), and a physical activity and step journal (INT) to a comparison group receiving a generic, two-page public health PA resource (Standard Material: SM).
연구 유형
등록 (예상)
단계
- 2 단계
연락처 및 위치
연구 장소
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Alberta
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Calgary, Alberta, 캐나다
- 모병
- Tom Baker Cancer Centre
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Grande Prairie, Alberta, 캐나다
- 모병
- Grande Prairie Cancer Centre
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Lethbridge, Alberta, 캐나다
- 모병
- Lethbridge Cancer Centre
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Medicine Hat, Alberta, 캐나다
- 모병
- Medicine Hat Cancer Centre
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Red Deer, Alberta, 캐나다
- 모병
- Central Alberta Cancer Centre
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- are diagnosed with stage I -IIIA breast cancer
- are scheduled to receive neoadjuvant or adjuvant chemotherapy
- did not receive transabdominal rectus abdominus muscle (TRAM) reconstructive surgery
- are >18 years of age
- receive approval from their treating oncologist to participate
- do not have uncontrolled hypertension, cardiac illness, or psychiatric conditions (i.e., indicated in patient medical charts).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: PA Behavior Intervention
Physical Activity Resource Kit
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The Intervention group (INT) will receive a Physical Activity Resource Kit which includes a step pedometer, a breast cancer-specific Physical Activity Guidebook (Exercise for health), a step pedometer resource (Step into survivorship), and a physical activity and step journal to record their daily step totals and daily physical activities. Participants will be instructed to wear their pedometer for the entire duration of the study (i.e., chemotherapy duration). |
|
활성 비교기: Standard Materials
Receive physical activity handout from the Canadian Public Health Agency
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Participants in this usual care group will receive a generic physical activity leaflet from the Canadian Public Health Agency
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Self-reported physical activity
기간: Baseline, post intervention, 6 months follow up
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Baseline, post intervention, 6 months follow up
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Cancer specific health related quality of life
기간: Baseline, post intervention, 6 months follow up
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Baseline, post intervention, 6 months follow up
|
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Psychosocial health outcomes
기간: Baseline, post intervention, 6 months follow up
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Baseline, post intervention, 6 months follow up
|
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Objective step counts (pedometer)
기간: Baseline, post intervention, 6 months follow up
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Baseline, post intervention, 6 months follow up
|
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Chemotherapy completion rate
기간: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
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Determinants of physical activity
기간: Baseline, post intervention, 6 months follow up
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Baseline, post intervention, 6 months follow up
|
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Physical functioning
기간: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Jeff Vallance, PhD, Athabasca University
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 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. .