Lifestyle Modification Program for Lung Cancer Patients -... | NCT04104516

Studies
Lifestyle Modification Program for Lung Cancer Patients - Physical Activity Preference

NCT04104516

Sponsor

The University of Hong Kong

Status

Unknown status

Last Update Posted

Apr 28, 2020Actual

Enrollment

70Estimated

Phase

Not provided

Conditions

Lung Cancer

Interventions

Not provided

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 26, 2019Actual

Primary Completion Date

Apr 30, 2021Estimated

Completion Date

Apr 30, 2021Estimated

First Submitted Date

Sep 24, 2019

First Submission Date that Met QC Criteria

Sep 24, 2019

First Posted Date

Sep 26, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2020

Last Update Posted Date

Apr 28, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Agnes Yuen-Kwan Lai, Assistant Professor, The University of Hong KongPrincipal Investigator

Lead Sponsor

The University of Hong KongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Lung cancer is the leading cause of deaths in the world. Engagement in physical activity can provide important benefits for cancer patients. The current study is a cross-sectional questionnaire survey and in-depth interview to understand the physical activity preferences of patients with lung cancer. This process could help to develop a lifestyle modification program based on our patients' needs and preferences.

Detailed Description

Lung cancer is one of the most common cancer globally and locally. Patients with lung cancer are in a uniquely difficult 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. However, most of the findings were predominantly in breast and colorectal cancers. The PA dosage required to attain health benefits across these cancer groups is not uniform, nor is it clear whether the results can be applied to other groups of people with cancer.

The current study includes a cross-sectional questionnaire survey and an in-depth interview. It aims to understand the current physical activity practice and preference of patients with lung cancer, which could help to develop a lifestyle modification program based on our patients' needs and preferences.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Preference on physical activity program	Outcome-based questions with categorical choices	immediately after obtaining written consent

Secondary Outcomes

Measure	Description	Time Frame
Current physical activity practise	Outcome-based questions with categorical choices	immediately after obtaining written consent
Preference on information to be received	Outcome-based questions with categorical choices

Other Outcomes

Not provided

Eligibility Module

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
Mental, cognitive and physically fit for joining the trial as determined by the clinician or responsible investigator

Exclusion Criteria:

Mentally unfit for answering questionnaire
Unable to give informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with lung cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
LAI YK Agnes, PhD	Contact	852-9317-6328		agneslai@hku.hk
Mary Ip, MD	Contact	852-2255-4455		msmip@hku.hk

Overall Officials

Name	Affiliation	Role
LAI YK Agnes, PhD	School of Nursing, The University of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Queen Mary Hospital	Recruiting	Hong Kong			Hong Kong

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
3920711	Background	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.
30741408	Background	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.

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms