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

NCT04826835 | Unknown

• 1 other identifier: UW 19-214
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Prehabilitation; Physical activity; Lung resection; Functional capacity

Outcome Measures

Primary Outcomes (1)

• Change from baseline 6-minute walking distance from baseline to 3-month post-surgery

  Baseline; 3-month post-surgery

Secondary Outcomes (18)

• Change from baseline 6-minute walking distance 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

• 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)

Study Arms (2)

Prehabilitation intervention

EXPERIMENTAL

Participants in the intervention group will follow a 2-week prehabilitation program before lung resection.

Behavioral: Prehabilitation intervention

Health education control

ACTIVE COMPARATOR

Participants in the control group will receive health education classes during 2 weeks before lung resection.

Behavioral: Health education control

Interventions

Prehabilitation intervention BEHAVIORAL

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.

Prehabilitation intervention

Health education control BEHAVIORAL

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.

Health education control

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior

Central Study Contacts

Chia-chin Lin, PhD

CONTACT

39176614; cclin@hku.hk

Xinyi Xu, BSN

CONTACT

39176948; xuxinyi@connect.hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: April 1, 2021
• Study Start: May 14, 2021
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)