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

Sponsor
The University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT05050370
Collaborator
(none)
16
1
1
9.9
1.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Brief messaging and personalized support
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
The experimental group will receive a face-to-face group session and a package of information on lifestyle-integrated exercise and physical activity.The experimental group will receive a face-to-face group session and a package of information on lifestyle-integrated exercise and physical activity.
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Brief SMART Exercise With Chat-based Instant Messaging Personalised Support Intervention
Actual Study Start Date :
Feb 4, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in fatigue level at 6 week [Baseline and 6 weeks]

    measured by Functional Assessment of Cancer Therapy - Fatigue subscale, the higher scores, the more fatigue.

Secondary Outcome Measures

  1. Change in Anxiety and depressive symptoms at 6 weeks [Baseline and 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.

  2. Change in sleep quality at 6 weeks [Baseline and 6 weeks]

    measured by the Pittsburgh sleep quality index . The higher the score, the worse the quality.

  3. Change in Health-related quality of life at 6 weeks [Baseline and 6 weeks]

    measured by the European Organization for Research and Treatment of Cancer and Lung Module. The higher scores the worse the quality.

  4. Change in Subjective Happiness at 6 weeks [Baseline and 6 weeks]

    measured by Subjective Happiness Scale. The higher scores the more happy.

  5. Change in Pain at 6 weeks [Baseline and 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.

  6. Change in dyspnea at 6 weeks [Baseline and 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.

  7. Change in activity level at 6 weeks [Baseline and 6 weeks]

    measured by pedometer

  8. Change in hand grip strength at 6 weeks [Baseline and 6 weeks]

    measured by a dynamometer

  9. Change in balance at 6 weeks [Baseline and 6 weeks]

    measured by single leg stand test

  10. Change in flexibility at 6 weeks [Baseline and 6 weeks]

    measured by chair sit and reach test

  11. Change in sleep quality with objective measurement at 6 weeks [Baseline and 6 weeks]

    measured by activity monitor on duration of sleep and awake intervals

  12. Change in physical activity level with objective measurement at 6 weeks [Baseline and 6 weeks]

    measured by accelerometer on the daily walking steps

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Queen Mary Hospital Hong Kong Hong Kong

Sponsors and Collaborators

  • The University of Hong Kong

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Dr. Agnes Yuen-Kwan Lai, Assistant professor, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT05050370
Other Study ID Numbers:
  • UW20-019
First Posted:
Sep 20, 2021
Last Update Posted:
Sep 20, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Agnes Yuen-Kwan Lai, Assistant professor, The University of Hong Kong

Study Results

No Results Posted as of Sep 20, 2021