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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
120
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.
Queen Mary Hospital
Hong Kong, Hong Kong
RECRUITINGChange 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.
Time frame: Baseline and 6 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6 weeks, 6 months
Change in sleep quality
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6 weeks and 6 months
Change in grip strength
Measured by a dynamometer
Time frame: Baseline, 6 weeks and 6 months
Change in lower limb strength
Measured by 30-second chair stand test.
Time frame: Baseline, 6 weeks, and 6 months
Change in balance
Measured by single-leg-stance test
Time frame: Baseline, 6 weeks and 6 months
Change in flexibility
Measured by chair sit and reach test
Time frame: Baseline, 6 weeks, and 6 months
Change in objective physical activity levels, including duration, frequency and intensity
Measured by a waist-worn accelerometer
Time frame: Baseline, 6 weeks, and 6 months
Change in sleep and wake intervals
Measured by watch-like activity monitor
Time frame: Baseline, 6 weeks , and 6 months
Change in exercise capacity
Measured by a 6-min walk test
Time frame: Baseline, 6 weeks and 6 months