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

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: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Behavioral: Prehabilitation intervention; Behavioral: Health education control

• Study Type: Interventional
• Enrollment (Estimated): 198
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chia-chin Lin, PhD; Phone Number: 39176614; Email: cclin@hku.hk
• Study Contact Backup: Name: Xinyi Xu, BSN; Phone Number: 39176948; Email: xuxinyi@connect.hku.hk

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Change from baseline 6-minute walking distance from baseline to 3-month post-surgery	Baseline; 3-month post-surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline 6-minute walking distance at post-intervention	Baseline; 2 weeks (post-intervention)
Length of postoperative hospital stay	1-month post-surgery
Postoperative complication	1-month post-surgery
Change from baseline functional assessment of cancer treatment - Lung (FACT-L) at post-intervention	Baseline; 2 weeks (post-intervention)
Change from baseline international physical activity questionnaire (IPAQ) at post-intervention	Baseline; 2 weeks (post-intervention)
Change from baseline daily step count measured by pedometer at post-intervention	Baseline; 2 weeks (post-intervention)
Change from baseline 6-minute walking distance at 1-month post-surgery	Baseline; 1-months post-surgery
Change from baseline functional assessment of cancer treatment - Lung (FACT-L) at 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	Baseline; 3-month post-surgery
Change from baseline international physical activity questionnaire (IPAQ) at 1-month post-surgery	Baseline; 1-month post-surgery
Change from baseline international physical activity questionnaire (IPAQ) at 3-month post-surgery	Baseline; 3-month post-surgery
Change from baseline daily step count measured by pedometer at 1-month post-surgery	Baseline; 1-month post-surgery
Change from baseline daily step count measured by pedometer at 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)	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)	Baseline; 2 weeks (post-intervention); 1-month post-surgery; 3-month post-surgery
Physical activity self-efficacy (9-item Self-Efficacy for Exercise, SEE)	Baseline; 2 weeks (post-intervention); 1-month post-surgery; 3-month post-surgery
Financial toxicity (COmprehensive Score for financial Toxicity, COST questionnaire)	Baseline; 3-month post-surgery
Return to work (investigator-designed questionnaire)	3-month post-surgery

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2021
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Physical activity; Prehabilitation; Functional capacity; Lung resection
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID 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