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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05331391
• Other study ID #: UW21-148
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2022
• Source: The University of Hong Kong
• Contact: Agnes Lai, PhD
• Phone: 852-3917-6328
• Email: agneslai[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 30, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (12)

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Nan H, Ni MY, Lee PH, Tam WW, Lam TH, Leung GM, McDowell I. Psychometric evaluation of the Chinese version of the Subjective Happiness Scale: evidence from the Hong Kong FAMILY Cohort. Int J Behav Med. 2014 Aug;21(4):646-52. doi: 10.1007/s12529-014-9389-3. — View Citation

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Santos-Lozano A, Santín-Medeiros F, Cardon G, Torres-Luque G, Bailón R, Bergmeir C, Ruiz JR, Lucia A, Garatachea N. Actigraph GT3X: validation and determination of physical activity intensity cut points. Int J Sports Med. 2013 Nov;34(11):975-82. doi: 10.1055/s-0033-1337945. Epub 2013 May 22. — View Citation

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* Note: There are 12 references in all — Click here to view all references

Outcome

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