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.
研究概览
详细说明
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.
研究类型
介入性
注册 (预期的)
120
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Agnes Lai, PhD
- 电话号码：852-3917-6328
- 邮箱：agneslai@hku.hk
研究联系人备份
- 姓名：George Cheung, MPhil
- 电话号码：852-3917-6563
- 邮箱：ocgeorge@hku.hk
学习地点
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Hong Kong、香港
- 招聘中
- Queen Mary Hospital
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接触：
- Agnes Lai, PhD
- 电话号码：852-3917-6283
- 邮箱：agneslai@hku.hk
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接触：
- David Lam, PhD
- 电话号码：852-2255-4455
- 邮箱：slnga@hku.hk
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首席研究员：
- Agnes YK Lai, PhD
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 100年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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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安慰剂比较：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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in fatigue level
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in fatigue level
大体时间：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.
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Baseline and 6 months
|
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Change in anxiety symptoms
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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.
|
Baseline, 6 weeks, 6 months
|
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Change in cancer-related symptoms
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：Baseline, 6 weeks and 6 months
|
Measured by a dynamometer
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Baseline, 6 weeks and 6 months
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Change in lower limb strength
大体时间：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
大体时间：Baseline, 6 weeks and 6 months
|
Measured by single-leg-stance test
|
Baseline, 6 weeks and 6 months
|
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Change in flexibility
大体时间：Baseline, 6 weeks, and 6 months
|
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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Agnes YK Lai, PhD、School of Nursing, The University of Hong Kong
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage. 1997 Feb;13(2):63-74. doi: 10.1016/s0885-3924(96)00274-6.
- 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.
- Koller M, Hjermstad MJ, Tomaszewski KA, Tomaszewska IM, Hornslien K, Harle A, Arraras JI, Morag O, Pompili C, Ioannidis G, Georgiou M, Navarra C, Chie WC, Johnson CD, Himpel A, Schulz C, Bohrer T, Janssens A, Kulis D, Bottomley A. An international study to revise the EORTC questionnaire for assessing quality of life in lung cancer patients. Ann Oncol. 2017 Nov 1;28(11):2874-2881. doi: 10.1093/annonc/mdx453.
- Chie WC, Yang CH, Hsu C, Yang PC. Quality of life of lung cancer patients: validation of the Taiwan Chinese version of the EORTC QLQ-C30 and QLQ-LC13. Qual Life Res. 2004 Feb;13(1):257-62. doi: 10.1023/B:QURE.0000015295.74812.06.
- Nan H, Ni MY, Lee PH, Tam WW, Lam TH, Leung GM, McDowell I. Psychometric evaluation of the Chinese version of the Subjective Happiness Scale: evidence from the Hong Kong FAMILY Cohort. Int J Behav Med. 2014 Aug;21(4):646-52. doi: 10.1007/s12529-014-9389-3.
- Roberts HC, Denison HJ, Martin HJ, Patel HP, Syddall H, Cooper C, Sayer AA. A review of the measurement of grip strength in clinical and epidemiological studies: towards a standardised approach. Age Ageing. 2011 Jul;40(4):423-9. doi: 10.1093/ageing/afr051. Epub 2011 May 30.
- Jones CJ, Rikli RE, Max J, Noffal G. The reliability and validity of a chair sit-and-reach test as a measure of hamstring flexibility in older adults. Res Q Exerc Sport. 1998 Dec;69(4):338-43. doi: 10.1080/02701367.1998.10607708.
- Newton R. Review of tests of standing balance abilities. Brain Inj. 1989 Oct-Dec;3(4):335-43. Review.
- Santos-Lozano A, Santin-Medeiros F, Cardon G, Torres-Luque G, Bailon R, Bergmeir C, Ruiz JR, Lucia A, Garatachea N. Actigraph GT3X: validation and determination of physical activity intensity cut points. Int J Sports Med. 2013 Nov;34(11):975-82. doi: 10.1055/s-0033-1337945. Epub 2013 May 22.
- Bonomi AG, Westerterp KR. Advances in physical activity monitoring and lifestyle interventions in obesity: a review. Int J Obes (Lond). 2012 Feb;36(2):167-77. doi: 10.1038/ijo.2011.99. Epub 2011 May 17. Review.
- Kushida CA, Chang A, Gadkary C, Guilleminault C, Carrillo O, Dement WC. Comparison of actigraphic, polysomnographic, and subjective assessment of sleep parameters in sleep-disordered patients. Sleep Med. 2001 Sep;2(5):389-96.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年5月1日
初级完成 (预期的)
2023年6月30日
研究完成 (预期的)
2024年9月30日
研究注册日期
首次提交
2022年4月11日
首先提交符合 QC 标准的
2022年4月11日
首次发布 (实际的)
2022年4月15日
研究记录更新
最后更新发布 (实际的)
2022年6月1日
上次提交的符合 QC 标准的更新
2022年5月29日
最后验证
2022年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.