A Prehabilitation Program to Boost Postoperative Functional Capacity in Surgical Lung Cancer Patients

January 3, 2024 updated by: Professor Chia-Chin Lin, The University of Hong Kong

A Prehabilitation Program to Boost Postoperative Functional Capacity in Surgical Lung Cancer Patients: a Randomized Controlled Trial

This research study is evaluating a prehabiliation intervention designed to improve postoperative functional capacity (measured by 6-minure walking distance) in individuals undergoing lung resection for cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
198

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Chia-chin Lin, PhD
  • Phone Number: 39176614
  • Email: cclin@hku.hk

Study Contact Backup

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients who are diagnosed of stage I, II, or IIIA Non-small-cell lung carcinoma (NSCLC) diagnosis, with or without pre-operative histologic confirmation
  2. Patients scheduled to undergo lung resection surgery at least two weeks from recruitment
  3. Patients with a Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 at recruitment
  4. Patients with no evidence of recurrent or progressive disease
  5. Patients aged 45-80 years
  6. Patients able to communicate in Cantonese, Mandarin, or English
  7. Patients is absence of any cognitive impairment
  8. Patients with a score of 6 minutes walking test (6MWT) ≤ 500 meters at baseline. [rationale: a threshold value of 500 meters preoperative 6MWT predicts a higher risk of postoperative complications and prolonged LOS after lung resection]
  9. Engagement in less than 150 minutes of moderate aerobic activity per week in the past 3 months

Exclusion Criteria:

  1. Patients who had engaged in at least 150 minutes of moderate aerobic activity or 75 minutes of vigorous aerobic activity per week in the past three months
  2. Presence of another concurrent, actively treated malignancy
  3. Presence of chronic obstructive pulmonary disease
  4. Presence of significant comorbidities that impede ability to engage in exercise, such as congestive heart failure, orthopedic disorders of the lower limbs, respiratory failure, or the need for portable oxygen therapy for activities of daily living
  5. Not having a smart device to receive WhatsApp messages

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Prehabilitation intervention
Participants in the intervention group will follow a 2-week prehabilitation program before lung resection.
Behavioral: Prehabilitation intervention

Participants will:

  • Receive four supervised exercise classes (twice per week for two weeks) one-to-one by an exercise specialist;
  • Practice six sessions of home-based exercise (three times per week for two weeks);
  • Practice unsupervised respiratory muscle training at home (twice daily for two weeks);
  • Receive usual care.
Active Comparator: Health education control
Participants in the control group will receive health education classes during 2 weeks before lung resection.
Behavioral: Health education control

Participants will:

  • Receive four recorded health education talks (twice per week for two weeks)
  • Receive a brief health education booklet on dietary education for chronic lung conditions, preoperative preparation, and postoperative recovery
  • Receive usual care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline 6-minute walking distance from baseline to 3-month post-surgery
Time Frame: Baseline; 3-month post-surgery
Baseline; 3-month post-surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline 6-minute walking distance at post-intervention
Time Frame: Baseline; 2 weeks (post-intervention)
Baseline; 2 weeks (post-intervention)
Length of postoperative hospital stay
Time Frame: 1-month post-surgery
1-month post-surgery
Postoperative complication
Time Frame: 1-month post-surgery
1-month post-surgery
Change from baseline functional assessment of cancer treatment - Lung (FACT-L) at post-intervention
Time Frame: Baseline; 2 weeks (post-intervention)
Baseline; 2 weeks (post-intervention)
Change from baseline international physical activity questionnaire (IPAQ) at post-intervention
Time Frame: Baseline; 2 weeks (post-intervention)
Baseline; 2 weeks (post-intervention)
Change from baseline daily step count measured by pedometer at post-intervention
Time Frame: Baseline; 2 weeks (post-intervention)
Baseline; 2 weeks (post-intervention)
Change from baseline 6-minute walking distance at 1-month post-surgery
Time Frame: Baseline; 1-months post-surgery
Baseline; 1-months post-surgery
Change from baseline functional assessment of cancer treatment - Lung (FACT-L) at 1-month post-surgery
Time Frame: Baseline; 2 weeks (post-intervention); 1-month post-surgery
Baseline; 2 weeks (post-intervention); 1-month post-surgery
Change from baseline functional assessment of cancer treatment - Lung (FACT-L) at 3-months post-surgery
Time Frame: Baseline; 3-month post-surgery
Baseline; 3-month post-surgery
Change from baseline international physical activity questionnaire (IPAQ) at 1-month post-surgery
Time Frame: Baseline; 1-month post-surgery
Baseline; 1-month post-surgery
Change from baseline international physical activity questionnaire (IPAQ) at 3-month post-surgery
Time Frame: Baseline; 3-month post-surgery
Baseline; 3-month post-surgery
Change from baseline daily step count measured by pedometer at 1-month post-surgery
Time Frame: Baseline; 1-month post-surgery
Baseline; 1-month post-surgery
Change from baseline daily step count measured by pedometer at 3-month post-surgery
Time Frame: Baseline; 3-month post-surgery
Baseline; 3-month post-surgery
Health-related quality of life for the cost-effectiveness analysis (EuroQol- 5 Dimension, EQ-5D-5L)
Time Frame: Baseline; 2 weeks (post-intervention); 1-month post-surgery; 3-month post-surgery
Baseline; 2 weeks (post-intervention); 1-month post-surgery; 3-month post-surgery
Health-related quality of life for the cost-effectiveness analysis (EuroQol-Visual Analog Score, EQ-VAS)
Time Frame: Baseline; 2 weeks (post-intervention); 1-month post-surgery; 3-month post-surgery
Baseline; 2 weeks (post-intervention); 1-month post-surgery; 3-month post-surgery
Physical activity self-efficacy (9-item Self-Efficacy for Exercise, SEE)
Time Frame: Baseline; 2 weeks (post-intervention); 1-month post-surgery; 3-month post-surgery
Baseline; 2 weeks (post-intervention); 1-month post-surgery; 3-month post-surgery
Financial toxicity (COmprehensive Score for financial Toxicity, COST questionnaire)
Time Frame: Baseline; 3-month post-surgery
Baseline; 3-month post-surgery
Return to work (investigator-designed questionnaire)
Time Frame: 3-month post-surgery
3-month post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 14, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UW 19-214

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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