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Status unknownNCT04105647Updated Apr 28, 2020

Lifestyle Modification Program for Lung Cancer Patients - A Pilot Study

An interventional study of Lifestyle-integrated exercise and Healthy living information in Cancer, Lung, sponsored by The University of Hong Kong. Status unknown at 2 sites in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-28.

Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cancer, Lung

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Keywords

  • Lifestyle modification
  • physical activity
  • messages
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 32 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (estimated)

Study arms

  • 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

  • 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

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

    Also known as: Experimental group

  • BehavioralHealthy 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.

    Also known as: Control group

06

What researchers measure

Primary outcomes

  1. Change in fatigue level at 6 weeks

    measured by Brief Fatigue Inventory

    Time frame: Baseline and 6 weeks

Secondary outcomes

  1. Change in physical activity at 6 weeks

    measured by International Physical Assessment Questionnaire - Short version

    Time frame: Baseline and 6 weeks

  2. Change in health-related quality of life at 6 weeks

    measured by European Organisation for Research and Treatment of Cancer and lung module questionnaire

    Time frame: Baseline and 6 weeks

  3. Change in functional level at 6 weeks

    measured by Functional Assessment Cancer Therapy - Lung (FACT-L) questionnaire

    Time frame: Baseline and 6 weeks

  4. 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.

    Time frame: Baseline and 6 weeks

  5. Change in insomnia level at 6 weeks

    measured by Insomnia Severity Index

    Time frame: Baseline and 6 weeks

  6. Change in sleep quality at 6 weeks

    measured by Pittsburgh Sleep Quality Index

    Time frame: Baseline and 6 weeks

  7. 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.

    Time frame: Baseline and 6 weeks

  8. Change in activity level at 6 weeks

    measured by fitbits

    Time frame: Baseline and 6 weeks

  9. Change in hand grips strength at 6 weeks

    measured by a dynamometer

    Time frame: Baseline and 6 weeks

  10. 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

    Time frame: Baseline and 6 weeks

  11. 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

    Time frame: Baseline and 6 weeks

  12. Change in flexibility at 6 weeks

    assessed by chair sit and reach test

    Time frame: Baseline and 6 weeks

  13. Change in endurance at 6 weeks

    assessed by 6-minute walk

    Time frame: Baseline and 6 weeks

07

Study locations

2 of 2 sites recruiting
  • Agnes
    Hong Kong, 852, Hong Kong
    • Agnes YK Lai · Contact · agneslai@hku.hk
    • Agnes YK Lai, PhD · Principal investigator
    Recruiting
  • Queen Mary Hospital
    Hong Kong, Hong Kong
    • Agnes YK Lai, PhD · Contact · agneslai@hku.hk · 852-3917-6328
    • Mary MS Ip, MD · Contact · msmip@hku.hk · 852-2255-4455
    • Agnes YK Lai, PhD · Principal investigator
    Recruiting
08

References and documents

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. PubMed 3920711 ↗
  • 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. PubMed 30741408 ↗

Individual participant data

Plan to share: No — The patient consent did not include sharing personal information to other researchers

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04105647
Lead sponsor
The University of Hong Kong
Responsible party
Dr. Agnes Yuen-Kwan Lai (Assistant Professor, The University of Hong Kong) — Principal investigator
First posted
Sep 26, 2019
Start date
Oct 1, 2019
Primary completion
Apr 30, 2021 (estimated)
Completion
May 30, 2021 (estimated)
Last update
Apr 28, 2020

Study contacts

LAI Agnes, PhD
Contact
agneslai@hku.hk
852-3917-6328
Mary Ip, MD
Contact
msmip@hku.hk
852-2255-4455
Agnes Lai
principal investigator · The University of Hong Kong

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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