Clinical trial NCT05050370: A Brief SMART Exercise Instant Messaging Support Intervention - a Pilot Study
Official title: A Brief SMART Exercise With Chat-based Instant Messaging Personalised Support Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Lung
Keywords: Lifestyle modification
physical activity
e-messages
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in fatigue level at 6 week
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Change in Anxiety and depressive symptoms at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in sleep quality at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in Health-related quality of life at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in Subjective Happiness at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in Pain at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in dyspnea at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in activity level at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in hand grip strength at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in balance at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in flexibility at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in sleep quality with objective measurement at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in physical activity level with objective measurement at 6 weeks
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Agnes Lai, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gopalakrishnan S, Takemoto L. Binding of actin to lens alpha crystallins. Curr Eye Res. 1992 Sep;11(9):929-33. doi: 10.3109/02713689209033490.
citation: 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.