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

Not Applicable

Recruiting

• Conditions: Lung Cancer
• Interventions: Behavioral: Prehabilitation intervention; Behavioral: Health education control

• Registration Number: NCT04826835
• Lead Sponsor: The University of Hong Kong

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-03-23
• Study First Submitted QC: 2021-03-29
• Study First Posted: 2021-04-01
• Study Start: 2021-05-14
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-08
• Primary Completion: 2025-05-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 198

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prehabilitation intervention	Prehabilitation intervention	Participants in the intervention group will follow a 2-week prehabilitation program before lung resection.
Health education control	Health education control	Participants in the control group will receive health education classes during 2 weeks before lung resection.

Primary Outcome Measures

Name	Time	Method
Change from baseline 6-minute walking distance from baseline to 3-month post-surgery	Baseline; 3-month post-surgery

Secondary Outcome Measures

Name	Time	Method
Length of postoperative hospital stay	1-month post-surgery
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 post-intervention	Baseline; 2 weeks (post-intervention)
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 daily step count measured by pedometer at 1-month post-surgery	Baseline; 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 3-month post-surgery	Baseline; 3-month post-surgery
Change from baseline daily step count measured by pedometer at post-intervention	Baseline; 2 weeks (post-intervention)
Postoperative complication	1-month post-surgery
Change from baseline international physical activity questionnaire (IPAQ) at post-intervention	Baseline; 2 weeks (post-intervention)
Change from baseline international physical activity questionnaire (IPAQ) at 1-month post-surgery	Baseline; 1-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
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
Physical activity self-efficacy (9-item Self-Efficacy for Exercise, SEE)	Baseline; 2 weeks (post-intervention); 1-month post-surgery; 3-month post-surgery
Change from baseline 6-minute walking distance at post-intervention	Baseline; 2 weeks (post-intervention)
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-Visual Analog Score, EQ-VAS)	Baseline; 2 weeks (post-intervention); 1-month post-surgery; 3-month post-surgery

Trial Locations

Locations (1)

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong