Lifestyle Modification Program for Lung Cancer Patients - A Pilot Study

Study Overview
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Brief Summary
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Lung cancer is one of the most common cancer diseases, globally and locally. Several health benefits of increased physical activity (PA) have been reported for people with cancer. PA plays a critical role across the cancer trajectory, from prevention through to post-diagnosis and has been proposed as an alternative for improving physical and psychosocial health outcomes, reducing cancer recurrence, and cancer-specific and all-cause mortality. Although there are a variety of exercise intervention programs for cancer patients, those programs were quite intensive, requiring individuals to commit extra time and effort. Feeling of overwhelmed appointments, lack of time, other barriers, including high cost and limited access to facilities are the most frequently reported barriers that prevent people from starting and maintaining exercise. Hence, the investigators propose to use a brief messaging lifestyle modification intervention program to incorporating simple and easy-to-do patient-centred home-based lifestyle-integrated exercise into daily activities of patients with lung cancer. The aims are to increase patients' physical activity and improve their fatigue, emotion and quality of life, compared to the control group.

Detailed Description
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Lung cancer is one of the most common cancer, globally and locally. Patients with lung cancer are in a uniquely challenging situation in their disease, comorbidities, and treatment that may lead to worsened symptoms and many negative health consequences, including fatigue, irritability, and impaired daytime functioning. Physical activity (PA) is defined as 'any bodily movement produced by skeletal muscle that results in energy expenditure'. Several health benefits of increased PA have been reported for people with cancer. PA plays a critical role across the cancer trajectory, from prevention through to post-diagnosis and has been proposed as an alternative for improving physical and psychosocial health outcomes, reducing cancer recurrence, and cancer-specific and all-cause mortality. Although there are a variety of exercise intervention programs for cancer patients, those programs were quite intensive, requiring individuals to commit extra time and effort. Most clinicians underutilise exercise therapy, regardless of its low-cost way to improve symptoms and potential health outcomes. Feeling of overwhelmed appointments, lack of time, other barriers, including high cost and limited access to facilities are the most frequently reported barriers that prevent people from starting and maintaining exercise. Low motivation, fear to exercise, lack of knowledge about benefits are the most common barriers of engaging in physical activity for cancer patients. Hence, the current proposal is to use a brief messaging lifestyle modification intervention program to incorporating simple and easy-to-do patient-centred home-based lifestyle-integrated exercise (light to moderate physical activity) into daily activities of patients with lung cancer. The investigators hypothesised that patients in the experimental group would display significantly higher increases in physical activity and improvements in fatigue, emotion and quality of life, compared to the control group. The objectives are to examine the short-term clinical effects on impacts on fatigue, emotion and quality of life in patients with lung cancer, and to evaluate the feasibility of a brief lifestyle-integrated exercise program to increase physical activity by a pilot study with objective fitness and subjective questionnaire assessment, and focus group interviews.

Official Title
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A Brief Messaging Lifestyle Modification Program for Patients With Non-small Cell Lung Cancer - A Pilot Study

Conditions
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Cancer, Lung

Intervention / Treatment
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* Behavioral: Lifestyle-integrated exercise
* Behavioral: Healthy living information


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 years and above; Diagnosis with non-small cell lung cancer General condition stable, either is undergoing or finished treatment Able to speak and read Chinese Able to complete the self-administered questionnaire Able to use instant messages such as WhatsApp or WeChat Mental, cognitive and physically fit determined by the clinicians/investigators Signed informed consent Exclusion Criteria: Pre-operative lung cancer Skeletal fragility Serious active infection Inability to walk Previously untreated symptomatic brain metastases Severe respiratory insufficiency Uncontrolled pain

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The control group will receive a face-to-face group session and a package of instant messages related to healthy living information, but no information on lifestyle-integrated exercise and physical activity. The experimental group will receive a face-to-face group session and a package of information on lifestyle-integrated exercise and physical activity.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Patients in the experimental group will receive a face-to-face group session and a package of healthy lifestyle instant messages, including lifestyle-integrated exercise and physical activity. | Behavioral: Lifestyle-integrated exercise<br>* The experimental group will receive a face-to-face group session and a package of instant messages related to lifestyle-integrated exercise and physical activity. The lifestyle-integrated exercise is modified from Zero-time exercise. It focuses on four exercise domains that patients with lung cancer could be done at home, including breathing, balance, aerobic, strength, stretching exercises<br>* Other names: Experimental group;|
| Placebo Comparator: Control group<br>The control group will receive a face-to-face group session and a package of healthy lifestyle instant messages, but not related to lifestyle-integrated exercise and physical activity. | Behavioral: Healthy living information<br>* The control group will receive a face-to-face group session and a package healthy living instant messages, but not related to lifestyle-integrated exercise and physical activity.<br>* Other names: Control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fatigue level at 6 weeks | measured by Brief Fatigue Inventory | Baseline and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical activity at 6 weeks | measured by International Physical Assessment Questionnaire - Short version | Baseline and 6 weeks | 
| Change in health-related quality of life at 6 weeks | measured by European Organisation for Research and Treatment of Cancer and lung module questionnaire | Baseline and 6 weeks | 
| Change in functional level at 6 weeks | measured by Functional Assessment Cancer Therapy - Lung (FACT-L) questionnaire | Baseline and 6 weeks | 
| Change in anxiety and depression symptoms at 6 weeks | measured by Hospital Anxiety and Depression Scale. Each item is answered on a 4-point scale (0-3). The scores for the seven questions on depression are added together to obtain a score ranged from 0 to 21. The higher score the more depressed. The scores for the seven questions on anxiety are added together to obtain a score ranged from 0 to 21. The higher score the more anxiety. | Baseline and 6 weeks | 
| Change in insomnia level at 6 weeks | measured by Insomnia Severity Index | Baseline and 6 weeks | 
| Change in sleep quality at 6 weeks | measured by Pittsburgh Sleep Quality Index | Baseline and 6 weeks | 
| Change in excessive daytime sleepiness at 6 weeks | measured by Epworth Sleepiness Scale. It is a scale of increasing probability from 0 to 3 for eight different situations that most people engage in during their daily lives, though not necessarily every day. The scores for the eight questions are added together to obtain a score ranged from 0 to 24. The higher score the more sleepiness. | Baseline and 6 weeks | 
| Change in activity level at 6 weeks | measured by fitbits | Baseline and 6 weeks | 
| Change in hand grips strength at 6 weeks | measured by a dynamometer | Baseline and 6 weeks | 
| Change in lower limb strength at 6 weeks | assessed by using a 30-second chair stand test to record the number of stands from chair in 30 seconds | Baseline and 6 weeks | 
| Change in balance at 6 weeks | assessed by a single-leg-stance test by recording the time within which the individual could effectively achieve balance on one leg | Baseline and 6 weeks | 
| Change in flexibility at 6 weeks | assessed by chair sit and reach test | Baseline and 6 weeks | 
| Change in endurance at 6 weeks | assessed by 6-minute walk | Baseline and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lifestyle modification, physical activity, messages