- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03120819
Exercise Information for Women With Cancer
A Randomized Controlled Trial to Determine the Effect of Supplementing an Oncologist's Recommendation to Exercise With Multimedia on Fatigue Levels in Breast Cancer Patients
연구 개요
상세 설명
Purpose: Controlled, intervention trials suggest that exercise may be a useful strategy to manage symptoms and side effects associated with cancer treatment. However, practical programs that facilitate exercise engagement among cancer patients are few and have been insufficiently studied. Medical providers may be best suited to deliver exercise information because of their frequent patient contact and the trust that patients place in their advice; however, unless sufficient resources are supplied in conjunction with verbal advice, patients may be less likely to successfully follow their physician's advice. The addition of an easy-to-follow, cancer specific exercise instructional video (DVD) to a provider's recommendation to exercise may provide patients with the motivation and ability to increase physical activity. We propose a feasibility study that will 1) determine acceptance and use of a provider-disseminated instructional home-exercise DVD among female cancer patients treated at OHSU and 2) determine if this cancer specific home-based DVD exercise program leads to greater decreases in fatigue, increases in exercise motivation and in physical activity compared to a standard exercise recommendation only among breast cancer patients treated at OHSU (N=100).
Methods: Medical providers who see female cancer patients during routine clinical visits will be approached to participate in the study. Willing providers will be enlisted to consent patients to receive a brief conversation (2-3 minutes) about the importance of exercise in their cancer care and then ask whether or not patients are willing to receive more information about the study from study staff. Providers will inform study staff about consenting participants who will then be randomized to one of two groups in the order that they enrolled. Study staff will then contact participants by phone to further explain the study and confirm eligibility then ask questions about their treatment, symptoms, and physical activity history. Based on their randomly assigned group, participants will receive either a control packet of standard exercise information based on guidelines from the American Cancer Society or standard exercise information plus a cancer specific home-based exercise DVD program. Fatigue, motivation for exercise, physical activity and use / acceptability of exercise information (+/- DVD) will be reassessed at 4 and 8 weeks following enrollment.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Oregon
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Portland, Oregon, 미국, 97239
- OHSU School of Nursing
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Diagnosis of breast cancer
- Scheduled for a clinical appointment with a surgical, radiation or medical oncologist at Oregon Health & Science University (OHSU)
- Capable of answering survey questions by phone
Exclusion Criteria:
- Not medically cleared to participate in low-intensity exercise
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Oncologist Recommendation only
Medical providers in this study provide a standardized brief recommendation for exercise to a consenting patient during a clinical visit.
Patients randomized to this arm receive a packet that contained a study information sheet and standard published exercise information materials.
The standard materials consisted of publicly available exercise recommendations for cancer survivors from the American Cancer Society (ACS).
The packet of exercise information intended to represent general information about exercise and cancer that would be readily available to patients through the internet, a medical clinic, or cancer support services.
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Patients in this arm receive a 2-3 minute verbal recommendation about exercise from their treating oncologist
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실험적: Oncologist Recommendation + DVD
Participants in this arm receive the same oncologist's recommendation and written materials as the comparator group and also received an instructional yoga DVD.
Inclusion of the video is intended to provide patients with a tool for following the oncologist's exercise recommendation.
The instructional video contains a brief introduction from a breast cancer survivor, who was also featured in the exercise portion of the DVD, and safety information about lymphedema from a lymphedema therapist.
The exercise program is a 30-minute, low intensity, restorative yoga program to improve whole body flexibility and to be safe for participants who were in active treatment for cancer and/or who had metastatic disease.
Women are encouraged to use the DVD at least 3 times per week.
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Patients in this arm receive a 2-3 minute verbal recommendation about exercise from their treating oncologist and then be sent an instructional exercise DVD to follow at their home three times per week for eight weeks
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Patient-Reported Fatigue
기간: baseline, 4 and 8 weeks
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Fatigue will be measured with the Brief Profile of Mood States Fatigue subscale
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baseline, 4 and 8 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in self-efficacy for exercise
기간: baseline, 4 and 8 weeks
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Self-efficacy for exercise will be measured using the Self-Efficacy Assessment scale modified for exercise
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baseline, 4 and 8 weeks
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Change in exercise readiness assessed by the Stage of Change for exercise
기간: baseline, 4 and 8 weeks
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We will measure a person's readiness to engage in recommended levels of physical activity using the Stage of Change for behavior change modified for exercise
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baseline, 4 and 8 weeks
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Change in self-report physical activity measured with the International Physical Activity Questionnaire
기간: Baseline, 4 and 8 weeks
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We will measure changes in the reported time spent in physical activities per week
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Baseline, 4 and 8 weeks
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공동 작업자 및 조사자
간행물 및 유용한 링크
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 (실제)
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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Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen Breast Cancer...완전한
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Oncologist Recommendation에 대한 임상 시험
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