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Lifestyle Modification Program for Lung Cancer Patients - A Pilot Study

Primary Purpose

Cancer, Lung

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Lifestyle-integrated exercise
Healthy living information
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer, Lung focused on measuring Lifestyle modification, physical activity, messages

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AgnesRecruiting
  • Queen Mary HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in fatigue level at 6 weeks
measured by Brief Fatigue Inventory

Secondary Outcome Measures

Change in physical activity at 6 weeks
measured by International Physical Assessment Questionnaire - Short version
Change in health-related quality of life at 6 weeks
measured by European Organisation for Research and Treatment of Cancer and lung module questionnaire
Change in functional level at 6 weeks
measured by Functional Assessment Cancer Therapy - Lung (FACT-L) questionnaire
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.
Change in insomnia level at 6 weeks
measured by Insomnia Severity Index
Change in sleep quality at 6 weeks
measured by Pittsburgh Sleep Quality Index
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.
Change in activity level at 6 weeks
measured by fitbits
Change in hand grips strength at 6 weeks
measured by a dynamometer
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
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
Change in flexibility at 6 weeks
assessed by chair sit and reach test
Change in endurance at 6 weeks
assessed by 6-minute walk

Full Information

First Posted
September 24, 2019
Last Updated
April 25, 2020
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04105647
Brief Title
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
May 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Lung
Keywords
Lifestyle modification, physical activity, messages

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle-integrated exercise
Other Intervention Name(s)
Experimental group
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Healthy living information
Other Intervention Name(s)
Control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in fatigue level at 6 weeks
Description
measured by Brief Fatigue Inventory
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Change in physical activity at 6 weeks
Description
measured by International Physical Assessment Questionnaire - Short version
Time Frame
Baseline and 6 weeks
Title
Change in health-related quality of life at 6 weeks
Description
measured by European Organisation for Research and Treatment of Cancer and lung module questionnaire
Time Frame
Baseline and 6 weeks
Title
Change in functional level at 6 weeks
Description
measured by Functional Assessment Cancer Therapy - Lung (FACT-L) questionnaire
Time Frame
Baseline and 6 weeks
Title
Change in anxiety and depression symptoms at 6 weeks
Description
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
Title
Change in insomnia level at 6 weeks
Description
measured by Insomnia Severity Index
Time Frame
Baseline and 6 weeks
Title
Change in sleep quality at 6 weeks
Description
measured by Pittsburgh Sleep Quality Index
Time Frame
Baseline and 6 weeks
Title
Change in excessive daytime sleepiness at 6 weeks
Description
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
Title
Change in activity level at 6 weeks
Description
measured by fitbits
Time Frame
Baseline and 6 weeks
Title
Change in hand grips strength at 6 weeks
Description
measured by a dynamometer
Time Frame
Baseline and 6 weeks
Title
Change in lower limb strength at 6 weeks
Description
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
Title
Change in balance at 6 weeks
Description
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
Title
Change in flexibility at 6 weeks
Description
assessed by chair sit and reach test
Time Frame
Baseline and 6 weeks
Title
Change in endurance at 6 weeks
Description
assessed by 6-minute walk
Time Frame
Baseline and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LAI Agnes, PhD
Phone
852-3917-6328
Email
agneslai@hku.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Ip, MD
Phone
852-2255-4455
Email
msmip@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnes Lai
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Agnes
City
Hong Kong
ZIP/Postal Code
852
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnes YK Lai
Email
agneslai@hku.hk
First Name & Middle Initial & Last Name & Degree
Agnes YK Lai, PhD
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnes YK Lai, PhD
Phone
852-3917-6328
Email
agneslai@hku.hk
First Name & Middle Initial & Last Name & Degree
Mary MS Ip, MD
Phone
852-2255-4455
Email
msmip@hku.hk
First Name & Middle Initial & Last Name & Degree
Agnes YK Lai, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The patient consent did not include sharing personal information to other researchers
Citations:
PubMed Identifier
3920711
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.
Results Reference
background
PubMed Identifier
30741408
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.
Results Reference
background
Links:
URL
https://www.lung.org/lung-health-and-diseases/lung-disease-lookup/lung-cancer/resource-library/lung-cancer-fact-sheet.html
Description
American Lung Association - Lung Cancer

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Lifestyle Modification Program for Lung Cancer Patients - A Pilot Study

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