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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04826835
• Other study ID #: UW 19-214
• Status: Recruiting
• Phase: N/A
• Start date: May 14, 2021
• Est. completion date: June 1, 2025

Study information

• Verified date: January 2024
• Source: The University of Hong Kong
• Contact: Chia-chin Lin, PhD
• Phone: 39176614
• Email: cclin[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 198
• Est. completion date: June 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

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