암 치료 중 좌식 행동 감소 - RedSedCan 연구 (RedSedCan)
Summary
Reducing sedentary behavior during treatment is important to reduce the risk of future health problems in individuals undergoing cancer treatment. Therefore, the goal of this project is with a multicenter randomised controlled design investigate whether a digital support intervention during ongoing neo- or adjuvant cancer treatment for breast, prostate or colon cancer is effective in reducing sedentary lifestyle and improving well-being in the short and long term.
연구 개요
상세 설명
Description of the project
This project is about investigating the effect of a digital support intervention to reduce sedentary behavior in people with breast, prostate, or colorectal cancer during neo- or adjuvant cancer treatment. The digital support intervention has been developed with patients and researchers and consists of existing high-quality technology that provides support for setting and following goals. The people who use the digital support intervention also receive support from a physiotherapist to set goals for reduced sedentary time and get to choose which activities will replace the time spent sedentary.
The goal of the project
The goal of the project is to investigate the effects of a digital support intervention on reduced sedentary and well-being during ongoing cancer treatment, both in the short and long term. In addition, the project will study the health-economic effects, and climate benefits of using the digital support intervention. By focusing on reducing a sedentary lifestyle and replacing it with daily activities and/or physical activity, the health of individuals is expected to be positively affected in the short term through, for example, increased well-being and reduced side effects from cancer treatment, and the long term through a reduced risk of developing complications and new illness related to the cancer treatment, such as cardiovascular disease.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Petra von Heideken Wågert, Professor
- 전화번호: +46 (0)21-10 3188
- 이메일: petra.heideken.wagert@mdu.se
연구 연락처 백업
- 이름: Anna Henriksson
- 이메일: anna.km.henriksson@uu.se
연구 장소
-
-
-
Uppsala, 스웨덴
- 모병
- Akademiska sjukhuset
-
Västerås, 스웨덴
- 모병
- Västmanlands sjukhus
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Individuals diagnosed with breast, prostate, or colorectal cancer planned for or resently started neo- or adjuvant treatment (e.g. chemotherapy, radiotherapy, endocrine treatment) at the hospitals in Uppsala and Västerås, Sweden.
Exclusion Criteria:
- Individuals diagnosed with dementia.
- Individuals diagnosed with severe psychiatric disease.
- Individuals with severe loss of vision, or communicative ability.
- Individuals who cannot walk independently indoors with or without a walking aid.
- Individuals completed treatment for other cancer diseases less than 12 months ago or not recovered from previous cancer treatment.
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: Intervention
Participants receive a digital support intervention |
The program consists of commercially available technologies, e.g. applications including behavour change techniques for reducing sedentary behavior (SB) (i.e. self-monitorization of physical activity, reminders for breaking SB/doing physical activity, and providing feedback on physical activity/breaks from SB) and a webpage containing information and tips (provided in short videos and text) regarding how to reduce SB. The participants will be receive help with setting goals for reducing time spent in sedentary/being active and help with planning for what activities to do to replace time in sedentary. Participants will then have access to the webpage and download the application to their smartphones. Follow-up meetings with the physiotherapist (digital or physical) will be conducted after 2, 8 and 12 weeks after start of intervention. |
|
간섭 없음: Control
Control condition. Individuals receive the care as usual provided by the healthcare only. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Sedentary behavior time
기간: At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point.
|
The Axivity accelerometer is used for measuring the primary outcome of sedentary time, i.e. mean time spent in sedentary behavior/day. |
At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Sedentary behavior bouts
기간: At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point.
|
The Axivity accelerometer is used for measuring sedentary bouts, i.e. mean number of bouts/day and mean bouts time/day. |
At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point.
|
|
Physical activity
기간: At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point.
|
The Axivity accelerometer is used for measuring physical activity mean time/day and mean time spent in low-, moderate and high intensity physical activity. |
At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point.
|
|
Health-related quality of life
기간: At baseline, 3-months, 6 months, 12 months and 24 months.
|
Patient reported health related quality of life will be assessed with European Organization for Research and Treatment of Cancer QLQ C 30 and diagnose specific modules BR23, PR26 and CR29. |
At baseline, 3-months, 6 months, 12 months and 24 months.
|
|
Health-related quality of life
기간: At baseline, 3-months, 6 months, 12 months and 24 months.
|
Patient reported health related quality of life will be assessed with EQ5D, and used for calculation of Quality Adjusted Life Years. |
At baseline, 3-months, 6 months, 12 months and 24 months.
|
|
Cancer related fatigue
기간: At baseline, 3-months, 6 months, 12 months and 24 months.
|
Patient reported outcome cancer related fatigue is measured with Brief Fatigue Inventory. |
At baseline, 3-months, 6 months, 12 months and 24 months.
|
|
Fear of movement
기간: At baseline, 3-months, 6 months, 12 months and 24 months.
|
Patient reported outcome Fear of movement is assessed with Cancer specific Tampa Scale for Kinesiophobia. |
At baseline, 3-months, 6 months, 12 months and 24 months.
|
|
Changes in health
기간: At 3-months, 6 months, 12 months and 24 months.
|
Patient reported outcome Changes in health is assessed with Patient Global Impression of Change Scale. |
At 3-months, 6 months, 12 months and 24 months.
|
|
Work ability
기간: At baseline, 3-months, 6 months, 12 months and 24 months.
|
Selected and adapted questions from Work Ability Index are used for assessing patient reported outcome work ability. |
At baseline, 3-months, 6 months, 12 months and 24 months.
|
|
Self-efficacy for reducing sedentary behavior
기간: At baseline, 3-months, 6 months, 12 months and 24 months.
|
Study specific question is used for assessing patient reported outcome of Self-efficacy for reducing sedentary behavior. |
At baseline, 3-months, 6 months, 12 months and 24 months.
|
|
Perceived support from peers
기간: At baseline, 3-months, 6 months, 12 months and 24 months.
|
Study specific question is used for assessing patient reported outcome of Perceived support from peers. |
At baseline, 3-months, 6 months, 12 months and 24 months.
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Demographic variables
기간: Baseline
|
Study specific questions |
Baseline
|
|
Diagnoses
기간: At baseline
|
Data regarding cancer diagnose and if any, co-morbid conditions, are gathered from medical records or Swedish national quality registers. |
At baseline
|
|
Cancer treatment
기간: At baseline, 3-months, 6 months, 12 months and 24 months.
|
Data regarding planned and received oncological and surgical cancer treatment (type, dose, treatment start and end date of treatment) and any treatment related side-effects are gathered from medical records and Swedish quality registers. |
At baseline, 3-months, 6 months, 12 months and 24 months.
|
|
Health care costs
기간: At baseline, 3-months, 6 months, 12 months and 24 months.
|
Data regarding outpatient visits, hospitalization and prescribed medication is gathered from Swedish national quality registers. |
At baseline, 3-months, 6 months, 12 months and 24 months.
|
|
Costs of intervention
기간: At baseline, 3-months, 6 months, 12 months and 24 months.
|
Data regarding cost of application use and any cost for physical activity is gathered from study records and patient reported by study specific questions. |
At baseline, 3-months, 6 months, 12 months and 24 months.
|
|
Sick leave
기간: At baseline, 3-months, 6 months, 12 months and 24 months.
|
Data regarding sick leave, i.e. total number of days being on sick leave gathered from the Swedish insurance fund (data on sick leave more than 14 days) and patient reported study specific questions (data on sick leave less than 14 days). Data will be gathered from 6 months prior baseline (study specific questions are administered at baseline and register data will be gathered at baseline but will include any data 6 months prior baseline). |
At baseline, 3-months, 6 months, 12 months and 24 months.
|
|
Adherence
기간: At baseline, 3-months, 6 months, 12 months and 24 months.
|
Adherence to the intervention is assessed by Axivity accelometer and patient reported study specific questions. |
At baseline, 3-months, 6 months, 12 months and 24 months.
|
|
Green house gas emissions
기간: At baseline, 3-months, 6 months, 12 months and 24 months.
|
Green house emissions will be compared between the intervention and control group and estimated using a life cycle analysis of the technology used in the intervention, self-reported changes in climate behavior, and emissions from healthcare. |
At baseline, 3-months, 6 months, 12 months and 24 months.
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Petra von Heideken Wågert, Professor, Mälardalen University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2020/1120
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Individual medical information may not be shared with other researchers if the research questions are not within the scope of the current approved Swedish Ethical Review Board application (and any amendments) for this research. Only pseudonymous information may be shared after approval has been provided from the Swedish Ethical Review Board.
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. .