A Mobile SMART Exercise Support Program to Improve Fatigue in Lung Cancer Patients - A RCT
2022年5月29日 更新者：Dr. Agnes Yuen-Kwan Lai、The University of Hong Kong
A Brief Mobile SMART Exercise Support Program to Improve Fatigue in Patients With Advanced Lung Cancer - A Pragmatic Randomized Controlled Trial With Outcome and Process Evaluation
Lung cancer (LC) is a common cancer in the world.
Among all symptoms, Fatigue is considered as the most distressing medical condition of LC.
Prior studies revealed that physical activity effectively relieve fatigue and related problems.
The current study attempt to explore the effectiveness of SMART Exercise Support Program (SES) with the use of mobile instant messaging application, on reducing symptoms such as fatigue, and improving physical activity level, physical fitness performance, sleep quality and habits, and quality of life in advanced lung cancer (ALC) patients.
調査の概要
詳細な説明
Lung cancer (LC) is the most and second most common cancer globally and locally, respectively. Nearly half of LC patients are diagnosed in the advanced stage. Fatigue is perceived to be the most distressing symptom. Physical activity has been proposed as an alternative treatment to relieve fatigue and related problems.
Mobile instant messaging applications (e.g. WhatsApp/WeChat) are popular and inexpensive for interactive messaging. A systematic review showed a majority of messaging interventions were effective in diabetes self-management, weight loss, physical activity (PA), smoking cessation, and medication adherence.
The proposed randomized controlled trial (RCT) aims to examine the effectiveness of SES on relieving fatigue, pain, dyspnea, happiness, anxiety and depression symptoms, physical activity level, physical fitness performance, sleep quality and habits, and quality of life in ALC patients (SES group), compared to the General Hygiene Information (GHI, control) group.
Questionnaires and simple fitness tests will be used at baseline, 6-week, and 24-week assessments. Qualitative feedback will be obtained at the completion of the trial.
研究の種類
介入
入学 (予想される)
120
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Agnes Lai, PhD
- 電話番号：852-3917-6328
- メール：agneslai@hku.hk
研究連絡先のバックアップ
- 名前：George Cheung, MPhil
- 電話番号：852-3917-6563
- メール：ocgeorge@hku.hk
研究場所
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Hong Kong、香港
- 募集
- Queen Mary Hospital
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コンタクト：
- Agnes Lai, PhD
- 電話番号：852-3917-6283
- メール：agneslai@hku.hk
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コンタクト：
- David Lam, PhD
- 電話番号：852-2255-4455
- メール：slnga@hku.hk
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主任研究者：
- Agnes YK Lai, PhD
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～100年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Aged 18 years and above;
- Diagnosis of Stage III or IV non-small cell lung cancer;
- Edmonton Symptom Assessment System Scale fatigue symptom score ≥4 out of 10
- Self-reported engagement of <150 minutes of moderate intensity PA each week,
- Ambulatory and capable of all self-care activities (European Co-operative Oncology Group (ECOG) Performance Status of ≤2)
- Either undergoing or finished oncology therapy, biological agents and/or support care;
- Mentally, cognitively and physically fit to join the trial as determined by the doctor in-charge and responsible clinical investigators;
- Able to speak and read Chinese;
- Willing to complete the patient-reported outcome questionnaire;
- Completion of the Physical Activity Readiness Questionnaire; and
- Possession of a smartphone with instant messaging functions such as WhatsApp or WeChat.
Exclusion Criteria:
- Those preparing for lung operation;
- Skeletal fragility;
- Serious active infection;
- Inability to walk;
- Previously untreated symptomatic brain metastases;
- Severe respiratory insufficiency;
- Uncontrolled pain; or
- Diagnosed psychiatric illness with or without medication such as major depressive disorder.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Brief mobile SMART Exercise Support Program
Patients will receive a brief SMART Exercise individual session with instant messages and telephone coaching for exercise habit formation and maintenance.
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Patients will receive 1) a brief SMART Exercise individual face-to-face session; 2) a theory-based instant messaging (WhatsApp/WeChat) and telephone-delivered health coaching on a 2-stage tapering schedule.
Stage 1 (week 1 to 6): daily messages and two biweekly phone calls for exercise habit formation.
Stage 2 (week 7 to 12): messages twice a week and monthly phone calls for exercise habit maintenance.
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プラセボコンパレーター：General Hygiene Information (GHI)
Patients will receive an individual session, instant messages and telephone coaching regarding general hygiene information.
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Patients will receive 1) a brief SMART Exercise individual face-to-face session; 2) a theory-based instant messaging (WhatsApp/WeChat) and telephone-delivered health coaching on a 2-stage tapering schedule.
Stage 1 (week 1 to 6): daily messages and two biweekly phone calls for exercise habit formation.
Stage 2 (week 7 to 12): messages twice a week and monthly phone calls for exercise habit maintenance.
|
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 |
|---|---|---|
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Change in fatigue level
時間枠：Baseline and 6 weeks
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Measured by a 13-item Functional Assessment of Cancer Therapy - Fatigue subscale.
The level of fatigue is measured on a five-point Likert scale.
The scale range is 0 to 52, with 0 being the worst possible score and 52 being the best possible score indicating no fatigue.
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Baseline and 6 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in fatigue level
時間枠：Baseline and 6 months
|
Measured by a 13-item Functional Assessment of Cancer Therapy - Fatigue subscale.
The level of fatigue is measured on a five-point Likert scale.
The scale range is 0 to 52, with 0 being the worst possible score and 52 being the best possible score indicating no fatigue.
|
Baseline and 6 months
|
|
Change in anxiety symptoms
時間枠：Baseline, 6 weeks, 6 months
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Measured by a 7-item Generalised Anxiety Disorder Assessment.
Each item asks the individual to rate the severity of his or her symptoms with a 4-point Likert scale.
The total score ranges from 0 to 21.
The higher scores the greater severity of anxiety symptoms.
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Baseline, 6 weeks, 6 months
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Change in depression symptoms
時間枠：Baseline, 6 weeks, 6 months
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Measured by a 9-item Patient Health Questionaire.
Each item asks the individual to rate the severity of his or her symptoms with a 4-point Likert scale.
The total score ranges from 0 to 27.
The higher scores the greater severity of depression symptoms.
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Baseline, 6 weeks, 6 months
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Change in physical activity level
時間枠：Baseline, 6 weeks, 6 months
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Measured the days and duration of physical activity level and sitting time in the past 7 days by the International Physical Activity Questionnaire (short version) with 4 questions.
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Baseline, 6 weeks, 6 months
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Change in sleep quality
時間枠：Baseline, 6 weeks, 6 months
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Measured by 7-item Severe Insomnia Index.
Each item asks the individual to rate the severity of his or her symptoms with a 4-point Likert scale.
The total score ranges from 0 to 28.
The higher scores the greater severity of insomnia.
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Baseline, 6 weeks, 6 months
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Change in health-related quality of life
時間枠：Baseline, 6 weeks, 6 months
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Measured by a 30-item European Organization for Research and Treatment of Cancer and Lung Module.
It contains five functioning scales (physical, social, role, cognitive, and emotional functioning), and eight symptom scales (fatigue, nausea/vomiting, pain, dyspnea, sleep disturbances, appetite loss, constipation, and diarrhoea), and financial impact, and overall quality of life.
All scale scores are linearly converted to a range from 0 to 100.
Higher scores indicate better functioning for the functioning scales and global QOL; for the symptom scales, higher scores indicate higher symptom burden.
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Baseline, 6 weeks, 6 months
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Change in happiness level
時間枠：Baseline, 6 weeks, 6 months
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Measured by 4-item Subjective Happiness Scale with a 7-point Likert scale.
Total scores range from 4 to 28.
The highest scores reflect greater happiness.
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Baseline, 6 weeks, 6 months
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Change in cancer-related symptoms
時間枠：Baseline, 6 weeks and 6 months
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Measured by 3 items of the Edmonton Symptom Assessment System Scale.
The severity at the time of assessment of each symptom is rated from 0 to 10 on a numerical scale, 0 meaning that the symptom is absent and 10 that it is of the worst possible severity.
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Baseline, 6 weeks and 6 months
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Change in acceptance of illness
時間枠：Baseline, 6 weeks and 6 months
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Measured by a 5-item subscale of Peace, Equanimity, and Acceptance in the Cancer Experience questionnaire
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Baseline, 6 weeks and 6 months
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Change in exercise self-efficacy
時間枠：Baseline, 6 weeks and 6 months
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Measured by a question with a scale from 0 to 10; "0" indicates no exercise self-efficacy, while "10" indicates highest level of exercise self-efficacy.
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Baseline, 6 weeks and 6 months
|
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Change in social and family support
時間枠：Baseline, 6 weeks and 6 months
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Measured by 8-item family and friend subscales of multidimensional Scale of Perceived Social Support with a 7-point Likert scale.
Each scale ranges from 4 to 28.
A higher score equates with higher social support.
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Baseline, 6 weeks and 6 months
|
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Change in grip strength
時間枠：Baseline, 6 weeks and 6 months
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Measured by a dynamometer
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Baseline, 6 weeks and 6 months
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Change in lower limb strength
時間枠：Baseline, 6 weeks, and 6 months
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Measured by 30-second chair stand test.
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Baseline, 6 weeks, and 6 months
|
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Change in balance
時間枠：Baseline, 6 weeks and 6 months
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Measured by single-leg-stance test
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Baseline, 6 weeks and 6 months
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Change in flexibility
時間枠：Baseline, 6 weeks, and 6 months
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Measured by chair sit and reach test
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Baseline, 6 weeks, and 6 months
|
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Change in objective physical activity levels, including duration, frequency and intensity
時間枠：Baseline, 6 weeks, and 6 months
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Measured by a waist-worn accelerometer
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Baseline, 6 weeks, and 6 months
|
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Change in sleep and wake intervals
時間枠：Baseline, 6 weeks , and 6 months
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Measured by watch-like activity monitor
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Baseline, 6 weeks , and 6 months
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Change in exercise capacity
時間枠：Baseline, 6 weeks and 6 months
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Measured by a 6-min walk test
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Baseline, 6 weeks and 6 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Agnes YK Lai, PhD、School of Nursing, The University of Hong Kong
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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- Ho RT, Fong TC. Factor structure of the Chinese version of the Pittsburgh sleep quality index in breast cancer patients. Sleep Med. 2014 May;15(5):565-9. doi: 10.1016/j.sleep.2013.10.019. Epub 2014 Feb 18.
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2022年5月1日
一次修了 (予想される)
2023年6月30日
研究の完了 (予想される)
2024年9月30日
試験登録日
最初に提出
2022年4月11日
QC基準を満たした最初の提出物
2022年4月11日
最初の投稿 (実際)
2022年4月15日
学習記録の更新
投稿された最後の更新 (実際)
2022年6月1日
QC基準を満たした最後の更新が送信されました
2022年5月29日
最終確認日
2022年5月1日
詳しくは
本研究に関する用語
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?
いいえ
IPD プランの説明
For those who want the patient data, please contact PI directly by written email.
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