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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04105647
Enrollment
32
Registered
2019-09-26
Start date
2019-10-01
Completion date
2021-05-30
Last updated
2020-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Lung

Keywords

Lifestyle modification, physical activity, messages

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.

Interventions

BEHAVIORALLifestyle-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

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.

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in fatigue level at 6 weeksBaseline and 6 weeksmeasured by Brief Fatigue Inventory

Secondary

MeasureTime frameDescription
Change in health-related quality of life at 6 weeksBaseline and 6 weeksmeasured by European Organisation for Research and Treatment of Cancer and lung module questionnaire
Change in functional level at 6 weeksBaseline and 6 weeksmeasured by Functional Assessment Cancer Therapy - Lung (FACT-L) questionnaire
Change in anxiety and depression symptoms at 6 weeksBaseline and 6 weeksmeasured 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.
Change in insomnia level at 6 weeksBaseline and 6 weeksmeasured by Insomnia Severity Index
Change in sleep quality at 6 weeksBaseline and 6 weeksmeasured by Pittsburgh Sleep Quality Index
Change in excessive daytime sleepiness at 6 weeksBaseline and 6 weeksmeasured 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.
Change in physical activity at 6 weeksBaseline and 6 weeksmeasured by International Physical Assessment Questionnaire - Short version
Change in hand grips strength at 6 weeksBaseline and 6 weeksmeasured by a dynamometer
Change in lower limb strength at 6 weeksBaseline and 6 weeksassessed by using a 30-second chair stand test to record the number of stands from chair in 30 seconds
Change in balance at 6 weeksBaseline and 6 weeksassessed by a single-leg-stance test by recording the time within which the individual could effectively achieve balance on one leg
Change in flexibility at 6 weeksBaseline and 6 weeksassessed by chair sit and reach test
Change in endurance at 6 weeksBaseline and 6 weeksassessed by 6-minute walk
Change in activity level at 6 weeksBaseline and 6 weeksmeasured by fitbits

Countries

Hong Kong

Contacts

Primary ContactLAI Agnes, PhD
agneslai@hku.hk852-3917-6328
Backup ContactMary Ip, MD
msmip@hku.hk852-2255-4455

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026