Home Based Exercise for Patients With Breast or Prostate Cancer (The BENEFIT-CA Study) (BENEFIT-CA)
2022년 8월 5일 업데이트: Hospital de Clinicas de Porto Alegre
Home Based Exercise for Patients With Breast or Prostate Cancer During Treatment: a Feasibility Trial (The BENEFIT-CA Study)
The purpose of this trial is to evaluate the feasibility of a home based exercise program for individuals with breast or prostate cancer patients undergoing active treatment.
연구 개요
상세 설명
This feasibility trial aims to assess a home-based exercise program, including a 3-month intervention of structured physical activity and health education for individuals with breast or prostate cancer. The main objective of this trial is to assess the adherence of cancer patients to a program of structured exercise, mixed with a health education approach, implemented and accompanied in a remote approach.
The data collection will include variables related to: (a) recruitment and retentions rates; (b) attendance to exercise sessions; (c) fatigue and quality of life levels; (d) functional capacity levels; (e) adverse events related or not to the study; (f) patient selected outcomes.
연구 유형
중재적
등록 (예상)
80
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Daniel Umpierre de Moraes, PhD
- 전화번호: 555133596332
- 이메일: danielumpierre@hcpa.edu.br
연구 연락처 백업
- 이름: Larissa Xavier Neves da Silva, Master
- 전화번호: 555133596332
- 이메일: larissaxns@gmail.com
연구 장소
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, 브라질, 90035-007
- 모병
- Hospital de Clinicas de Porto Alegre
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연락하다:
- Daniel Umpierre de Moraes, PhD
- 전화번호: 555133596332
- 이메일: danielumpierre@hcpa.edu.br
-
연락하다:
- Larissa Xavier Neves da Silva, MSc
- 전화번호: 555133596332
- 이메일: larissaxns@gmail.com
-
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- eighteen years old minimum;
- be living in Porto Alegre or metropolitan region;
- breast cancer stage 0 - III OR
- localized prostate cancer;
- undergoing hormonal treatment / manipulation in isolation or combined with other therapies three months prior to the entrance in the study;
- hormonal therapy / manipulation planned to be active throughout the study duration;
- not engaged in any exercise training for more than once a week for the past 6 months;
- in case of previous surgical procedure, the patient must have medical clearance at the moment of the contact to begin the study or be cleared to do so in the near future (up to two weeks).
Exclusion Criteria:
- metastatic phase / progression of the disease or active regional location prior to beginning of the study;
- inability to understand the terms and conditions of study due to language, hearing, cognitive or severe psychiatric issues;
- another family member, who lives at the same residence, participating in the study;
- planning to move or major absence (more than two weeks) during the study;
- history of cardiovascular disease (except controlled hypertension) or severe cardiopulmonary disease, as well as history of heart attack, revascularization procedures, profound venous thrombosis, encephalic vascular accident (brain stroke) or pulmonary embolism in the past twelve months;
- chronic pulmonary disease that requires oxygen or corticosteroid therapy;
- kidney disease with or that is going to begin the use of dialysis or waiting for a kidney transplant;
- severe nausea, anorexia or any other condition which does not allow to perform physical exercise;
- medical contraindication to exercise training.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Home-based exercise program
This is a single study arm consisting of a home-based exercise program for individuals with breast or prostate cancer during active treatment.
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The intervention will be based on a remote approach, lasting 12 weeks.
The training routine will consist of aerobic (walking), muscle strengthening and stretching exercises, with a frequency of three days per week.
The contents related to the exercise prescription will be made available by phone call, text messages and short videos for exercise demonstration.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Trial adherence
기간: Up to12 weeks.
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Proportion of self-reported exercise episodes (out of 36 episodes, total) during the study.
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Up to12 weeks.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Recruitment yields
기간: Up to 8 weeks before allocation to the study intervention.
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Proportion of included participants (who signed the informed consent) in relation to the total number of screened individuals for eligibility.
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Up to 8 weeks before allocation to the study intervention.
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Adverse events throughout the study
기간: Up to 12 weeks.
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Self-reported adverse events, related or not to the study.
These measures will be mostly received by phone calls or text messaging.
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Up to 12 weeks.
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Fatigue levels at baseline and at the end of the study
기간: Baseline; Week 12.
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Fatigue scores using specific questionnaires of Functional Assessment of Cancer Therapy (FACT questionnaire) for breast or prostate cancer patients.
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Baseline; Week 12.
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Quality of life, based on the Functional Assessment of Cancer Therapy (FACT questionnaire)
기간: Baseline; Week 12.
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Quality of life scores using specific questionnaires of FACT (Functional Assessment of Cancer Therapy) for breast or prostate cancer patients.
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Baseline; Week 12.
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Walking capacity
기간: Baseline; Week 12.
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Total distance (in meters) performed during the six minute walk test.
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Baseline; Week 12.
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Handgrip strength
기간: Baseline; Week 12.
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Maximum strength (in kgf) achieved by both hands in a handgrip test using a hand dynamometer.
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Baseline; Week 12.
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Abdominal circumference
기간: Baseline; Week 12.
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Anthropometric measure of the highest abdominal circumference, using a metallic measuring tape.
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Baseline; Week 12.
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Physical activity levels
기간: Single assessment at baseline.
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Physical activity calculated in minutes and intensity per week, of physical activity using the International Physical Activity Questionnaire (IPAQ).
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Single assessment at baseline.
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Patient selected outcomes
기간: Week 12.
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Through the development of the study, participants will be asked to engage in a focal group to discuss outcomes relevant to be assessed in trials with exercise interventions targeted for patients with breast or prostate cancer.
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Week 12.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Daniel Umpierre de Moraes, PhD, Hospital de Clinicas de Porto Alegre
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2022년 4월 7일
기본 완료 (예상)
2023년 12월 30일
연구 완료 (예상)
2023년 12월 30일
연구 등록 날짜
최초 제출
2022년 2월 7일
QC 기준을 충족하는 최초 제출
2022년 2월 25일
처음 게시됨 (실제)
2022년 2월 28일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 8월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 8월 5일
마지막으로 확인됨
2022년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2021-0262
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Files will be as de-identified as possible before public data sharing. After data protection and data handling routines, de-identified data will be readily available to all project contributors. We consider research data gathered from data collection from research participants pertains primarily to these individuals. Therefore, all individual data will be available to their owners throughout the project. Structured data that will result from this research project will pertain to the PI (Daniel Umpierre), who will be responsible for data integrity, and to the institution (Hospital de Clinicas de Porto Alegre).
The specific structure for data sharing as well as plataforms are still to be defined. As soon, we define the remaining details of our data sharing strategy the IPD plan will be updated.
IPD 공유 기간
Due to space and management constraints, we are planning:
- To retain and store project documentation (informed consents, IRB communication, subjects' communication) for at least 10 years after the study completion (anticipated time: up to 2033).
- To retain and share project resources (instruments, intervention materials) as long as public repositories (e.g., Zenodo, OSF, figshare) provide sharing services at no cost.
- To retain and share datasets as long as public repositories (e.g., Zenodo, OSF, figshare) provide sharing services at no cost.
IPD 공유 액세스 기준
All the files will be password-protected and only investigators or data managers designated to use the files will be given access.
Different passwords will be used for different users, which allows auditing to be made more easily.
Although we do not plan to request justification to release the datasets, we do plan to share the data in a controlled approach.
Therefore, once the datasets are made available at the Zenodo.org
platform, only registered users will be able to download files.
This procedure allows us to keep a record of data requests.
IPD 공유 지원 정보 유형
- 연구 프로토콜
- 정보에 입각한 동의서(ICF)
- 임상 연구 보고서(CSR)
- 분석 코드
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .