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

Primary Purpose

Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Brief mobile SMART Exercise Support Program
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Queen Mary HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Brief mobile SMART Exercise Support Program

General Hygiene Information (GHI)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Change in sleep quality
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.
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.
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.
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.
Change in acceptance of illness
Measured by a 5-item subscale of Peace, Equanimity, and Acceptance in the Cancer Experience questionnaire
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.
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.
Change in grip strength
Measured by a dynamometer
Change in lower limb strength
Measured by 30-second chair stand test.
Change in balance
Measured by single-leg-stance test
Change in flexibility
Measured by chair sit and reach test
Change in objective physical activity levels, including duration, frequency and intensity
Measured by a waist-worn accelerometer
Change in sleep and wake intervals
Measured by watch-like activity monitor
Change in exercise capacity
Measured by a 6-min walk test

Full Information

First Posted
April 11, 2022
Last Updated
May 29, 2022
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05331391
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
The outcome assessor did not aware of which groups the patients belongs to.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brief mobile SMART Exercise Support Program
Arm Type
Experimental
Arm Description
Patients will receive a brief SMART Exercise individual session with instant messages and telephone coaching for exercise habit formation and maintenance.
Arm Title
General Hygiene Information (GHI)
Arm Type
Placebo Comparator
Arm Description
Patients will receive an individual session, instant messages and telephone coaching regarding general hygiene information.
Intervention Type
Behavioral
Intervention Name(s)
Brief mobile SMART Exercise Support Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in fatigue level
Description
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
Secondary Outcome Measure Information:
Title
Change in fatigue level
Description
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
Title
Change in anxiety symptoms
Description
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
Title
Change in depression symptoms
Description
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
Title
Change in physical activity level
Description
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
Title
Change in sleep quality
Description
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
Title
Change in health-related quality of life
Description
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
Title
Change in happiness level
Description
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
Title
Change in cancer-related symptoms
Description
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
Title
Change in acceptance of illness
Description
Measured by a 5-item subscale of Peace, Equanimity, and Acceptance in the Cancer Experience questionnaire
Time Frame
Baseline, 6 weeks and 6 months
Title
Change in exercise self-efficacy
Description
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
Title
Change in social and family support
Description
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
Title
Change in grip strength
Description
Measured by a dynamometer
Time Frame
Baseline, 6 weeks and 6 months
Title
Change in lower limb strength
Description
Measured by 30-second chair stand test.
Time Frame
Baseline, 6 weeks, and 6 months
Title
Change in balance
Description
Measured by single-leg-stance test
Time Frame
Baseline, 6 weeks and 6 months
Title
Change in flexibility
Description
Measured by chair sit and reach test
Time Frame
Baseline, 6 weeks, and 6 months
Title
Change in objective physical activity levels, including duration, frequency and intensity
Description
Measured by a waist-worn accelerometer
Time Frame
Baseline, 6 weeks, and 6 months
Title
Change in sleep and wake intervals
Description
Measured by watch-like activity monitor
Time Frame
Baseline, 6 weeks , and 6 months
Title
Change in exercise capacity
Description
Measured by a 6-min walk test
Time Frame
Baseline, 6 weeks and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Agnes Lai, PhD
Phone
852-3917-6328
Email
agneslai@hku.hk
First Name & Middle Initial & Last Name or Official Title & Degree
George Cheung, MPhil
Phone
852-3917-6563
Email
ocgeorge@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnes YK Lai, PhD
Organizational Affiliation
School of Nursing, The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnes Lai, PhD
Phone
852-3917-6283
Email
agneslai@hku.hk
First Name & Middle Initial & Last Name & Degree
David Lam, PhD
Phone
852-2255-4455
Email
slnga@hku.hk
First Name & Middle Initial & Last Name & Degree
Agnes YK Lai, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
For those who want the patient data, please contact PI directly by written email.
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A Mobile SMART Exercise Support Program to Improve Fatigue in Lung Cancer Patients - A RCT

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