がん治療中の座りっぱなしの行動を減らす - RedSedCan 研究 (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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Petra von Heideken Wågert, Professor
- 電話番号：+46 (0)21-10 3188
- メール：petra.heideken.wagert@mdu.se
研究連絡先のバックアップ
- 名前：Anna Henriksson
- メール：anna.km.henriksson@uu.se
研究場所
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-
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Uppsala、スウェーデン
- 募集
- Akademiska sjukhuset
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Västerås、スウェーデン
- 募集
- Västmanlands sjukhus
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
|
介入なし：Control
Control condition. Individuals receive the care as usual provided by the healthcare only. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sedentary behavior time
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sedentary behavior bouts
時間枠：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
時間枠：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
時間枠：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.
|
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Health-related quality of life
時間枠：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
時間枠：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
時間枠：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.
|
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Changes in health
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Demographic variables
時間枠：Baseline
|
Study specific questions |
Baseline
|
|
Diagnoses
時間枠：At baseline
|
Data regarding cancer diagnose and if any, co-morbid conditions, are gathered from medical records or Swedish national quality registers. |
At baseline
|
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Cancer treatment
時間枠：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.
|
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Health care costs
時間枠：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.
|
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Costs of intervention
時間枠：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.
|
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Sick leave
時間枠：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.
|
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Adherence
時間枠：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
時間枠：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.
|
協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Petra von Heideken Wågert, Professor、Mälardalen University
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2020/1120
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
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米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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