NCT04826835RecruitingNot Applicable
A Prehabilitation Program to Boost Postoperative Functional Capacity in Surgical Lung Cancer Patients: a Randomized Controlled Trial
The University of Hong Kong1 site in 1 country198 target enrollmentStarted: May 14, 2021Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- The University of Hong Kong
- Enrollment
- 198
- Locations
- 1
- Primary Endpoint
- Change from baseline 6-minute walking distance from baseline to 3-month post-surgery
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 45 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who are diagnosed of stage I, II, or IIIA Non-small-cell lung carcinoma (NSCLC) diagnosis, with or without pre-operative histologic confirmation
- •Patients scheduled to undergo lung resection surgery at least two weeks from recruitment
- •Patients with a Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 at recruitment
- •Patients with no evidence of recurrent or progressive disease
- •Patients aged 45-80 years
- •Patients able to communicate in Cantonese, Mandarin, or English
- •Patients is absence of any cognitive impairment
- •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]
- •Engagement in less than 150 minutes of moderate aerobic activity per week in the past 3 months
Exclusion Criteria
- •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
- •Presence of another concurrent, actively treated malignancy
- •Presence of chronic obstructive pulmonary disease
- •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
- •Not having a smart device to receive WhatsApp messages
Arms & Interventions
Prehabilitation intervention
Experimental
Participants in the intervention group will follow a 2-week prehabilitation program before lung resection.
Intervention: Prehabilitation intervention (Behavioral)
Health education control
Active Comparator
Participants in the control group will receive health education classes during 2 weeks before lung resection.
Intervention: Health education control (Behavioral)
Outcomes
Primary Outcomes
Change from baseline 6-minute walking distance from baseline to 3-month post-surgery
Time Frame: Baseline; 3-month post-surgery
Secondary Outcomes
- 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 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)
- Length of postoperative hospital stay(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)
- 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)
Investigators
Professor Chia-Chin Lin
Professor and Head
The University of Hong Kong
Study Sites (1)
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