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

The University of Hong Kong (HKU)

Status: Enrolling

Conditions: Lung Cancer

Treatments: Behavioral: Brief mobile SMART Exercise Support Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05331391

UW21-148

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups, including a placebo group

Brief mobile SMART Exercise Support Program

Experimental group

Description:

Patients will receive a brief SMART Exercise individual session with instant messages and telephone coaching for exercise habit formation and maintenance.

Treatment:

Behavioral: Brief mobile SMART Exercise Support Program

General Hygiene Information (GHI)

Placebo Comparator group

Description:

Patients will receive an individual session, instant messages and telephone coaching regarding general hygiene information.

Treatment:

Behavioral: Brief mobile SMART Exercise Support Program