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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05050370
• Other study ID #: UW20-019
• Status: Recruiting
• Phase: N/A
• Start date: February 4, 2021
• Est. completion date: December 2021

Study information

• Verified date: September 2021
• 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Lung

Intervention

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.

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 (2)

Gopalakrishnan S, Takemoto L. Binding of actin to lens alpha crystallins. Curr Eye Res. 1992 Sep;11(9):929-33. — View Citation

Peddle-McIntyre CJ, Singh F, Thomas R, Newton RU, Galvão DA, Cavalheri V. Exercise training for advanced lung cancer. Cochrane Database Syst Rev. 2019 Feb 11;2:CD012685. doi: 10.1002/14651858.CD012685.pub2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change in Subjective Happiness at 6 weeks	measured by Subjective Happiness Scale. The higher scores the more happy.	Baseline and 6 weeks
Secondary	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
Secondary	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
Secondary	Change in activity level at 6 weeks	measured by pedometer	Baseline and 6 weeks
Secondary	Change in hand grip strength at 6 weeks	measured by a dynamometer	Baseline and 6 weeks
Secondary	Change in balance at 6 weeks	measured by single leg stand test	Baseline and 6 weeks
Secondary	Change in flexibility at 6 weeks	measured by chair sit and reach test	Baseline and 6 weeks
Secondary	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
Secondary	Change in physical activity level with objective measurement at 6 weeks	measured by accelerometer on the daily walking steps	Baseline and 6 weeks

External Links

•   American Lung Association - Lung Cancer