Lifestyle Modification Program for Lung Cancer Patients - A Pilot Study

Cancer, Lung Clinical Trial

Official title:

A Brief Messaging Lifestyle Modification Program for Patients With Non-small Cell Lung Cancer - A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04105647
• Other study ID #: UW19-597-2
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: May 30, 2021

Study information

• Verified date: April 2020
• Source: The University of Hong Kong
• Contact: LAI Agnes, 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 increase patients' physical activity and improve their fatigue, emotion and quality of life, compared to the control group.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: May 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer, Lung
• Lung Neoplasms

Intervention

Behavioral:
• Lifestyle-integrated exercise
The experimental group will receive a face-to-face group session and a package of instant messages related to lifestyle-integrated exercise and physical activity. The lifestyle-integrated exercise is modified from Zero-time exercise. It focuses on four exercise domains that patients with lung cancer could be done at home, including breathing, balance, aerobic, strength, stretching exercises
• Healthy living information
The control group will receive a face-to-face group session and a package healthy living instant messages, but not related to lifestyle-integrated exercise and physical activity.

Locations

Country	Name	City	State
Hong Kong	Agnes	Hong Kong
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)

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. — 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 weeks	measured by Brief Fatigue Inventory	Baseline and 6 weeks
Secondary	Change in physical activity at 6 weeks	measured by International Physical Assessment Questionnaire - Short version	Baseline and 6 weeks
Secondary	Change in health-related quality of life at 6 weeks	measured by European Organisation for Research and Treatment of Cancer and lung module questionnaire	Baseline and 6 weeks
Secondary	Change in functional level at 6 weeks	measured by Functional Assessment Cancer Therapy - Lung (FACT-L) questionnaire	Baseline and 6 weeks
Secondary	Change in anxiety and depression 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.	Baseline and 6 weeks
Secondary	Change in insomnia level at 6 weeks	measured by Insomnia Severity Index	Baseline and 6 weeks
Secondary	Change in sleep quality at 6 weeks	measured by Pittsburgh Sleep Quality Index	Baseline and 6 weeks
Secondary	Change in excessive daytime sleepiness at 6 weeks	measured by Epworth Sleepiness Scale. It is a scale of increasing probability from 0 to 3 for eight different situations that most people engage in during their daily lives, though not necessarily every day. The scores for the eight questions are added together to obtain a score ranged from 0 to 24. The higher score the more sleepiness.	Baseline and 6 weeks
Secondary	Change in activity level at 6 weeks	measured by fitbits	Baseline and 6 weeks
Secondary	Change in hand grips strength at 6 weeks	measured by a dynamometer	Baseline and 6 weeks
Secondary	Change in lower limb strength at 6 weeks	assessed by using a 30-second chair stand test to record the number of stands from chair in 30 seconds	Baseline and 6 weeks
Secondary	Change in balance at 6 weeks	assessed by a single-leg-stance test by recording the time within which the individual could effectively achieve balance on one leg	Baseline and 6 weeks
Secondary	Change in flexibility at 6 weeks	assessed by chair sit and reach test	Baseline and 6 weeks
Secondary	Change in endurance at 6 weeks	assessed by 6-minute walk	Baseline and 6 weeks

External Links

•   American Lung Association - Lung Cancer