Lifestyle Modification Program for Lung Cancer Patients - A Pilot Study

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

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.

Study Overview

• Status: Unknown
• Conditions: Cancer, Lung
• Intervention / Treatment: Behavioral: Lifestyle-integrated exercise; Behavioral: Healthy living information

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.

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Queen Mary Hospital
    • Principal Investigator: Agnes YK Lai, PhD
    • Contact: Agnes YK Lai, PhD; Phone Number: 852-3917-6328; Email: agneslai@hku.hk
    • Contact: Mary MS Ip, MD; Phone Number: 852-2255-4455; Email: msmip@hku.hk
  • Hong Kong, Hong Kong, 852
    • Recruiting
    • Agnes
    • Principal Investigator: Agnes YK Lai, PhD
    • Contact: Agnes YK Lai; Email: agneslai@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Patients in the experimental group will receive a face-to-face group session and a package of healthy lifestyle instant messages, including lifestyle-integrated exercise and physical activity.	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; Other Names: Experimental group
Placebo Comparator: Control group; The control group will receive a face-to-face group session and a package of healthy lifestyle instant messages, but not related to lifestyle-integrated exercise and physical activity.	Behavioral: 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.; Other Names: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fatigue level at 6 weeks	measured by Brief Fatigue Inventory	Baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in physical activity at 6 weeks	measured by International Physical Assessment Questionnaire - Short version	Baseline and 6 weeks
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
Change in functional level at 6 weeks	measured by Functional Assessment Cancer Therapy - Lung (FACT-L) questionnaire	Baseline and 6 weeks
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
Change in insomnia level at 6 weeks	measured by Insomnia Severity Index	Baseline and 6 weeks
Change in sleep quality at 6 weeks	measured by Pittsburgh Sleep Quality Index	Baseline and 6 weeks
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
Change in activity level at 6 weeks	measured by fitbits	Baseline and 6 weeks
Change in hand grips strength at 6 weeks	measured by a dynamometer	Baseline and 6 weeks
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
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
Change in flexibility at 6 weeks	assessed by chair sit and reach test	Baseline and 6 weeks
Change in endurance at 6 weeks	assessed by 6-minute walk	Baseline and 6 weeks

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• American Lung Association - Lung Cancer

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): April 30, 2021
• Study Completion (Anticipated): May 30, 2021

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: September 25, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 25, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: physical activity; Lifestyle modification; messages
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: UW19-597-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The patient consent did not include sharing personal information to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No