A Mobile SMART Exercise Support Program to Improve Fatigue in Lung Cancer Patients - A RCT

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Lung Cancer

Intervention / Treatment
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* Behavioral: Brief mobile SMART Exercise Support Program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The Experimental group will receive a brief SMART Exercise individual face-to-face session, and a package of information on lifestyle-integrated exercise and physical activity delivered through instant messaging and telephone calls. The Control group will receive a face-to-face individual session on general hygiene (GH) information, and a package of information on GH delivered through instant messaging and telephone calls.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief mobile SMART Exercise Support Program<br>Patients will receive a brief SMART Exercise individual session with instant messages and telephone coaching for exercise habit formation and maintenance. | Behavioral: Brief mobile SMART Exercise Support Program<br>* 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.<br>|
| Placebo Comparator: General Hygiene Information (GHI)<br>Patients will receive an individual session, instant messages and telephone coaching regarding general hygiene information. | Behavioral: Brief mobile SMART Exercise Support Program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fatigue level | 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 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fatigue level | 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 | 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. | Baseline, 6 weeks, 6 months | 
| Change in depression symptoms | 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. | Baseline, 6 weeks, 6 months | 
| Change in physical activity level | 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. | Baseline, 6 weeks, 6 months | 
| Change in sleep quality | 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. | Baseline, 6 weeks, 6 months | 
| Change in health-related quality of life | 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. | Baseline, 6 weeks, 6 months | 
| Change in happiness level | 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 | 
| Change in cancer-related symptoms | 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. | Baseline, 6 weeks and 6 months | 
| Change in acceptance of illness | Measured by a 5-item subscale of Peace, Equanimity, and Acceptance in the Cancer Experience questionnaire | Baseline, 6 weeks and 6 months | 
| Change in exercise self-efficacy | 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. | Baseline, 6 weeks and 6 months | 
| Change in social and family support | 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. | Baseline, 6 weeks and 6 months | 
| Change in grip strength | Measured by a dynamometer | Baseline, 6 weeks and 6 months | 
| Change in lower limb strength | Measured by 30-second chair stand test. | Baseline, 6 weeks, and 6 months | 
| Change in balance | Measured by single-leg-stance test | Baseline, 6 weeks and 6 months | 
| Change in flexibility | Measured by chair sit and reach test | Baseline, 6 weeks, and 6 months | 
| Change in objective physical activity levels, including duration, frequency and intensity | Measured by a waist-worn accelerometer | Baseline, 6 weeks, and 6 months | 
| Change in sleep and wake intervals | Measured by watch-like activity monitor | Baseline, 6 weeks , and 6 months | 
| Change in exercise capacity | Measured by a 6-min walk test | Baseline, 6 weeks and 6 months |