Clinical trial NCT04826835: A Prehabilitation Program to Boost Postoperative Functional Capacity in Surgical Lung Cancer Patients
Official title: A Prehabilitation Program to Boost Postoperative Functional Capacity in Surgical Lung Cancer Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: Prehabilitation
Physical activity
Lung resection
Functional capacity
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 198
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline 6-minute walking distance from baseline to 3-month post-surgery
timeFrame: Baseline; 3-month post-surgery
Secondary outcomes:
measure: Change from baseline 6-minute walking distance at post-intervention
timeFrame: Baseline; 2 weeks (post-intervention)
measure: Change from baseline 6-minute walking distance at 1-month post-surgery
timeFrame: Baseline; 1-months post-surgery
measure: Length of postoperative hospital stay
timeFrame: 1-month post-surgery
measure: Postoperative complication
timeFrame: 1-month post-surgery
measure: Change from baseline functional assessment of cancer treatment - Lung (FACT-L) at post-intervention
timeFrame: Baseline; 2 weeks (post-intervention)
measure: Change from baseline functional assessment of cancer treatment - Lung (FACT-L) at 1-month post-surgery
timeFrame: Baseline; 2 weeks (post-intervention); 1-month post-surgery
measure: Change from baseline functional assessment of cancer treatment - Lung (FACT-L) at 3-months post-surgery
timeFrame: Baseline; 3-month post-surgery
measure: Change from baseline international physical activity questionnaire (IPAQ) at post-intervention
timeFrame: Baseline; 2 weeks (post-intervention)
measure: Change from baseline international physical activity questionnaire (IPAQ) at 1-month post-surgery
timeFrame: Baseline; 1-month post-surgery
measure: Change from baseline international physical activity questionnaire (IPAQ) at 3-month post-surgery
timeFrame: Baseline; 3-month post-surgery
measure: Change from baseline daily step count measured by pedometer at post-intervention
timeFrame: Baseline; 2 weeks (post-intervention)
measure: Change from baseline daily step count measured by pedometer at 1-month post-surgery
timeFrame: Baseline; 1-month post-surgery
measure: Change from baseline daily step count measured by pedometer at 3-month post-surgery
timeFrame: Baseline; 3-month post-surgery
measure: Health-related quality of life for the cost-effectiveness analysis (EuroQol- 5 Dimension, EQ-5D-5L)
timeFrame: Baseline; 2 weeks (post-intervention); 1-month post-surgery; 3-month post-surgery
measure: Health-related quality of life for the cost-effectiveness analysis (EuroQol-Visual Analog Score, EQ-VAS)
timeFrame: Baseline; 2 weeks (post-intervention); 1-month post-surgery; 3-month post-surgery
measure: Physical activity self-efficacy (9-item Self-Efficacy for Exercise, SEE)
timeFrame: Baseline; 2 weeks (post-intervention); 1-month post-surgery; 3-month post-surgery
measure: Financial toxicity (COmprehensive Score for financial Toxicity, COST questionnaire)
timeFrame: Baseline; 3-month post-surgery
measure: Return to work (investigator-designed questionnaire)
timeFrame: 3-month post-surgery
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
References: