Clinical trial NCT04105647: Lifestyle Modification Program for Lung Cancer Patients - A Pilot Study
Official title: A Brief Messaging Lifestyle Modification Program for Patients With Non-small Cell Lung Cancer - A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer, Lung
Keywords: Lifestyle modification
physical activity
messages
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The control group will receive a face-to-face group session and a package of instant messages related to healthy living information, but no 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.
Primary purpose: TREATMENT

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 increase patients' physical activity and improve their fatigue, emotion and quality of life, compared to the control group.

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 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. 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 investigators hypothesised that patients in the experimental group would display significantly higher increases in physical activity and improvements in fatigue, emotion and quality of life, compared to the control group.

The objectives are to examine the short-term clinical effects on impacts on fatigue, emotion and quality of life in patients with lung cancer, and to evaluate the feasibility of a brief lifestyle-integrated exercise program to increase physical activity by a pilot study with objective fitness and subjective questionnaire assessment, and focus group interviews.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years and above;
* Diagnosis with non-small cell lung cancer
* General condition stable, either is undergoing or finished treatment
* Able to speak and read Chinese
* Able to complete the self-administered questionnaire
* Able to use instant messages such as WhatsApp or WeChat
* Mental, cognitive and physically fit determined by the clinicians/investigators
* Signed informed consent

Exclusion Criteria:

* Pre-operative lung cancer
* Skeletal fragility
* Serious active infection
* Inability to walk
* Previously untreated symptomatic brain metastases
* Severe respiratory insufficiency
* Uncontrolled pain

Primary outcomes:
measure: Change in fatigue level at 6 weeks
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Change in physical activity 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 functional level at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in anxiety and depression symptoms at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in insomnia level at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in sleep quality at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in excessive daytime sleepiness 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 grips strength at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in lower limb 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 endurance at 6 weeks
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Agnes
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Agnes Lai
role: PRINCIPAL_INVESTIGATOR
References:
citation: Caspersen CJ, Powell KE, Christenson GM. Physical activity, exercise, and physical fitness: definitions and distinctions for health-related research. Public Health Rep. 1985 Mar-Apr;100(2):126-31.
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.