A Brief SMART Exercise Instant Messaging Support Intervention - a Pilot Study

A Brief SMART Exercise With Chat-based Instant Messaging Personalised Support Intervention

Lung cancer is one of the most common cancer diseases, globally and locally. Several health benefits of increased physical activity (PA) have been reported for people with cancer. PA plays a critical role across the cancer trajectory, from prevention through to post-diagnosis and has been proposed as an alternative for improving physical and psychosocial health outcomes, reducing cancer recurrence, and cancer-specific and all-cause mortality. Although there are a variety of exercise intervention programs for cancer patients, those programs were quite intensive, requiring individuals to commit extra time and effort. Feeling of overwhelmed appointments, lack of time, other barriers, including high cost and limited access to facilities are the most frequently reported barriers that prevent people from starting and maintaining exercise. Hence, the investigators propose to use a brief messaging lifestyle modification intervention program to incorporating simple and easy-to-do patient-centred home-based lifestyle-integrated exercise into daily activities of patients with lung cancer. The aims are to explore the feasibility of using instant messaging to enhance physical activity and improve their fatigue, emotion and quality of life, and obtain feedback from patients for intervention and study design improvement.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Lung
• Intervention / Treatment: Behavioral: Brief messaging and personalized support

Detailed Description

Lung cancer is one of the most common cancer, globally and locally. Patients with lung cancer are in a uniquely challenging situation in their disease, comorbidities, and treatment that may lead to worsened symptoms and many negative health consequences, including fatigue, irritability, and impaired daytime functioning. Physical activity (PA) is defined as 'any bodily movement produced by skeletal muscle that results in energy expenditure'. Several health benefits of increased PA have been reported for people with cancer. PA plays a critical role across the cancer trajectory, from prevention through to postdiagnosis and has been proposed as an alternative for improving physical and psychosocial health outcomes, reducing cancer recurrence, and cancer-specific and all-cause mortality. Although there are a variety of exercise intervention programs for cancer patients, those programs were quite intensive, requiring individuals to commit extra time and effort. Most clinicians underutilise exercise therapy, regardless of its low-cost way to improve symptoms and potential health outcomes. Feeling of overwhelmed appointments, lack of time, other barriers, including high cost and limited access to facilities are the most frequently reported barriers that prevent people from starting and maintaining exercise. Low motivation, fear to exercise, lack of knowledge about benefits are the most common barriers of engaging in physical activity for cancer patients.

Hence, the current proposal is to use a brief messaging lifestyle modification intervention program to incorporating simple and easy-to-do patient-centred home-based lifestyle-integrated exercise (light to moderate physical activity) into daily activities of patients with lung cancer.

The aims are to explore the feasibility of using instant messaging to enhance physical activity and improve their fatigue, emotion and quality of life, and obtain feedback from patients for intervention and study design improvement.

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Agnes Lai, PhD; Phone Number: 852-3917-6328; Email: agneslai@hku.hk
• Study Contact Backup: Name: Asa Choi, MA; Phone Number: 852-3917-6563; Email: asachoi@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Queen Mary Hospital
    • Principal Investigator: Agnes YK Lai, PhD
    • Contact: Agnes Lai, PhD; Phone Number: 3917-6283; Email: agneslai@hku.hk
    • Contact: David Lam, PhD; Phone Number: 2255-4455; Email: slnga@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria

• Aged 18 years and above;
• Diagnosis of non-small cell lung cancer or small cell lung cancer
• 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
• Either undergoing or finished oncology therapy and/or support care
• Mentally, cognitively and physically fit to join the trial
• Able to speak and read Chinese;
• Willing to complete the patient-reported outcome questionnaire
• Completion of the Physical Activity Readiness Questionnaire
• 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
• Severe respiratory insufficiency
• Uncontrolled pain
• Diagnosed psychiatric illness such as major depressive disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lifestyle-integrated exercise and care support; The experimental group will receive a face-to-face group session and a package of instant messages related to lifestyle-integrated exercise and cancer-related information with personalized support.	Behavioral: Brief messaging and personalized support; Patients will receive (i) a face-to-face group session and a package of instant messages related to lifestyle-integrated exercise (including breathing, balance, aerobic, strength, stretching exercises), cancer-related care information and support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fatigue level at 6 week	measured by Functional Assessment of Cancer Therapy - Fatigue subscale, the higher scores, the more fatigue.	Baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Anxiety and depressive symptoms at 6 weeks	measured by Hospital Anxiety and Depression Scale, Each item is answered on a 4-point scale (0-3). The scores for the seven questions on depression are added together to obtain a score ranged from 0 to 21. The higher score the more depressed. The scores for the seven questions on anxiety are added together to obtain a score ranged from 0 to 21. The higher score the more anxiety and depression symptoms.	Baseline and 6 weeks
Change in sleep quality at 6 weeks	measured by the Pittsburgh sleep quality index . The higher the score, the worse the quality.	Baseline and 6 weeks
Change in Health-related quality of life at 6 weeks	measured by the European Organization for Research and Treatment of Cancer and Lung Module. The higher scores the worse the quality.	Baseline and 6 weeks
Change in Subjective Happiness at 6 weeks	measured by Subjective Happiness Scale. The higher scores the more happy.	Baseline and 6 weeks
Change in Pain at 6 weeks	measured by a question with a scale from 0 to 10; a score of "0" indicates no pain at all, a score of "10" indicates severe pain. The higher score, the more pain.	Baseline and 6 weeks
Change in dyspnea at 6 weeks	measured by a question with a scale from 0 to 10; a score of "0" indicates no dyspnea at all, a score of "10" indicates severe dyspnea. The higher score, the more dyspnea.	Baseline and 6 weeks
Change in activity level at 6 weeks	measured by pedometer	Baseline and 6 weeks
Change in hand grip strength at 6 weeks	measured by a dynamometer	Baseline and 6 weeks
Change in balance at 6 weeks	measured by single leg stand test	Baseline and 6 weeks
Change in flexibility at 6 weeks	measured by chair sit and reach test	Baseline and 6 weeks
Change in sleep quality with objective measurement at 6 weeks	measured by activity monitor on duration of sleep and awake intervals	Baseline and 6 weeks
Change in physical activity level with objective measurement at 6 weeks	measured by accelerometer on the daily walking steps	Baseline and 6 weeks

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Agnes Lai, PhD, The University of Hong Kong

Publications and helpful links

General Publications

• Gopalakrishnan S, Takemoto L. Binding of actin to lens alpha crystallins. Curr Eye Res. 1992 Sep;11(9):929-33. doi: 10.3109/02713689209033490.
• Peddle-McIntyre CJ, Singh F, Thomas R, Newton RU, Galvao DA, Cavalheri V. Exercise training for advanced lung cancer. Cochrane Database Syst Rev. 2019 Feb 11;2(2):CD012685. doi: 10.1002/14651858.CD012685.pub2.

Helpful Links

• American Lung Association - Lung Cancer

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: January 23, 2021
• First Submitted That Met QC Criteria: September 14, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): September 20, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: physical activity; Lifestyle modification; e-messages
• Other Study ID Numbers: UW20-019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: For those who want the patients 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