Clinical trial NCT05331391: A Mobile SMART Exercise Support Program to Improve Fatigue in Lung Cancer Patients - A RCT
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in fatigue level
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Change in fatigue level
timeFrame: Baseline and 6 months
measure: Change in anxiety symptoms
timeFrame: Baseline, 6 weeks, 6 months
measure: Change in depression symptoms
timeFrame: Baseline, 6 weeks, 6 months
measure: Change in physical activity level
timeFrame: Baseline, 6 weeks, 6 months
measure: Change in sleep quality
timeFrame: Baseline, 6 weeks, 6 months
measure: Change in health-related quality of life
timeFrame: Baseline, 6 weeks, 6 months
measure: Change in happiness level
timeFrame: Baseline, 6 weeks, 6 months
measure: Change in cancer-related symptoms
timeFrame: Baseline, 6 weeks and 6 months
measure: Change in acceptance of illness
timeFrame: Baseline, 6 weeks and 6 months
measure: Change in exercise self-efficacy
timeFrame: Baseline, 6 weeks and 6 months
measure: Change in social and family support
timeFrame: Baseline, 6 weeks and 6 months
measure: Change in grip strength
timeFrame: Baseline, 6 weeks and 6 months
measure: Change in lower limb strength
timeFrame: Baseline, 6 weeks, and 6 months
measure: Change in balance
timeFrame: Baseline, 6 weeks and 6 months
measure: Change in flexibility
timeFrame: Baseline, 6 weeks, and 6 months
measure: Change in objective physical activity levels, including duration, frequency and intensity
timeFrame: Baseline, 6 weeks, and 6 months
measure: Change in sleep and wake intervals
timeFrame: Baseline, 6 weeks , and 6 months
measure: Change in exercise capacity
timeFrame: Baseline, 6 weeks and 6 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: School of Nursing, The University of Hong Kong
name: Agnes YK Lai, PhD
role: PRINCIPAL_INVESTIGATOR
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