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

May 29, 2022 updated by: Dr. Agnes Yuen-Kwan Lai, The University of Hong Kong

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: George Cheung, MPhil
  • Phone Number: 852-3917-6563
  • Email: ocgeorge@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital
        • Contact:
        • Contact:
          • David Lam, PhD
          • Phone Number: 852-2255-4455
          • Email: slnga@hku.hk
        • Principal Investigator:
          • Agnes YK Lai, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brief mobile SMART Exercise Support Program
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
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.
Placebo Comparator: General Hygiene Information (GHI)
Patients will receive an individual session, instant messages and telephone coaching regarding general hygiene information.
Behavioral: Brief mobile SMART Exercise Support Program
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fatigue level
Time Frame: Baseline and 6 weeks
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
Time Frame: Baseline and 6 months
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
Time Frame: Baseline, 6 weeks, 6 months
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
Time Frame: Baseline, 6 weeks, 6 months
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
Time Frame: Baseline, 6 weeks, 6 months
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
Time Frame: Baseline, 6 weeks, 6 months
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
Time Frame: Baseline, 6 weeks, 6 months
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
Time Frame: Baseline, 6 weeks, 6 months
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
Time Frame: Baseline, 6 weeks and 6 months
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
Time Frame: Baseline, 6 weeks and 6 months
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
Time Frame: Baseline, 6 weeks and 6 months
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
Time Frame: Baseline, 6 weeks and 6 months
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
Time Frame: Baseline, 6 weeks and 6 months
Measured by a dynamometer
Baseline, 6 weeks and 6 months
Change in lower limb strength
Time Frame: Baseline, 6 weeks, and 6 months
Measured by 30-second chair stand test.
Baseline, 6 weeks, and 6 months
Change in balance
Time Frame: Baseline, 6 weeks and 6 months
Measured by single-leg-stance test
Baseline, 6 weeks and 6 months
Change in flexibility
Time Frame: Baseline, 6 weeks, and 6 months
Measured by chair sit and reach test
Baseline, 6 weeks, and 6 months
Change in objective physical activity levels, including duration, frequency and intensity
Time Frame: Baseline, 6 weeks, and 6 months
Measured by a waist-worn accelerometer
Baseline, 6 weeks, and 6 months
Change in sleep and wake intervals
Time Frame: Baseline, 6 weeks , and 6 months
Measured by watch-like activity monitor
Baseline, 6 weeks , and 6 months
Change in exercise capacity
Time Frame: Baseline, 6 weeks and 6 months
Measured by a 6-min walk test
Baseline, 6 weeks and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Agnes YK Lai, PhD, School of Nursing, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

September 30, 2024

Study Registration Dates

First Submitted

April 11, 2022

First Submitted That Met QC Criteria

April 11, 2022

First Posted (Actual)

April 15, 2022

Study Record Updates

Last Update Posted (Actual)

June 1, 2022

Last Update Submitted That Met QC Criteria

May 29, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW21-148

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

For those who want the patient data, please contact PI directly by written email.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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