Smartphone-based Remote Symptom Monitoring to Improve Postoperative Rehabilitation Exercise Adherence After Video-assisted Thoracic Surgery (VATS) for Lung Cancer

Sponsor

Zhongshan People's Hospital, Guangdong, China (Other)

Overall Status

Recruiting

CT.gov ID

NCT05990946

Collaborator

(none)

224

Enrollment

Location

Arms

Anticipated Duration (Months)

22.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Brief Summary: This randomized controlled trial aims to evaluate whether active remote symptom monitoring and management via a smartphone app utilizing electronic patient-reported outcomes (ePRO) can improve adherence to prescribed outpatient pulmonary rehabilitation exercises among postsurgical lung cancer patients. Eligible patients will use the app for perioperative care and be randomized to an intervention group receiving ePRO-based symptom monitoring with clinician feedback or a control group receiving ePRO without feedback. The primary outcome is rehabilitation exercise adherence rate over 1 month after discharge. If proven effective, the app-enabled remote rehabilitation model can be scaled up to enhance recovery for more postoperative patients.

Condition or Disease	Intervention/Treatment	Phase
Lung Neoplasms, Non-Small Cell Lung Cancer Postoperative Complications Patient Reported Outcome Measures Telerehabilitation Exercise Therapy	Procedure: ePRO based Remote Symptom Management	N/A

Detailed Description

Adherence to postoperative pulmonary rehabilitation exercises is crucial but challenging to address in lung cancer patients after hospital discharge. Pain, fatigue, cough and other symptoms may hinder adherence. This study will enroll 224 patients undergoing Video-assisted thoracic surgery (VATS) for lung Cancer. All patients will use a smartphone app for perioperative care and periodic PRO measurement. Before discharge, patients will be randomized 1:1 to an intervention group or control group. The intervention group will complete ePRO symptom severity scores on the PSA-Lung Scale questionnaire on discharge and post-discharge days 3, 7, 14, 21, 28. Alerts are triggered if any of 5 core symptoms scored ≥4, prompting remote clinician feedback and guidance. The control group will complete ePRO without clinician alerts. The primary outcome is rehabilitation exercise adherence rate over 1 month after discharge. Secondary outcomes include postoperative complications, hospital readmissions, symptom changes, exercise participation rate, and patient satisfaction. If proven effective, this innovative rehabilitation model can be scaled up to enhance recovery for more postoperative patients.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

224 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

A Prospective, Randomized, Controlled Study to Evaluate the Impact of Remote Symptom Management Via Smartphone App Based on Electronic Patient-Reported Outcomes on Rehabilitation Exercise Adherence After Minimally Invasive Surgery in Lung Cancer Patients

Actual Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Mar 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group Participants randomized to the intervention group will complete ePRO symptom severity scores on the PSA-Lung questionnaire via the smartphone app on discharge and post-discharge days 3, 7, 14, 21, 28. Alerts are triggered if any of 5 core symptoms scored ≥4, prompting remote clinician feedback and guidance on symptom management.	Procedure: ePRO based Remote Symptom Management Alerts are triggered if any of 5 core symptoms scored ≥4, prompting remote clinician feedback and guidance on symptom management. Other Names: Symptom Management
No Intervention: Control Group Participants randomized to the control group will complete ePRO symptom severity scores on the PSA-Lung questionnaire via the smartphone app on discharge and post-discharge days 3, 7, 14, 21, 28, without clinician alerts.

Arm

Intervention/Treatment

Experimental: Intervention Group

Participants randomized to the intervention group will complete ePRO symptom severity scores on the PSA-Lung questionnaire via the smartphone app on discharge and post-discharge days 3, 7, 14, 21, 28. Alerts are triggered if any of 5 core symptoms scored ≥4, prompting remote clinician feedback and guidance on symptom management.

Procedure: ePRO based Remote Symptom Management

Alerts are triggered if any of 5 core symptoms scored ≥4, prompting remote clinician feedback and guidance on symptom management.

Other Names:

Symptom Management

No Intervention: Control Group

Participants randomized to the control group will complete ePRO symptom severity scores on the PSA-Lung questionnaire via the smartphone app on discharge and post-discharge days 3, 7, 14, 21, 28, without clinician alerts.

Outcome Measures

Primary Outcome Measures

Rehabilitation exercise adherence rate over 1 month after discharge [From the day of discharge to 30 days after discharge]
Rehabilitation exercise adherence rate over 1 month after discharge, defined as the proportion of patients completing the prescribed outpatient exercise regimen.

Secondary Outcome Measures

Post-discharge pulmonary complication rate [From the day of discharge to 30 days after discharge]
30-day hospital readmission rate [From the day of discharge to 30 days after discharge]
Changes in symptom severity scores from discharge to 30 days [From the day of discharge to 30 days after discharge]
Patient satisfaction scores [From the day of discharge to 30 days after discharge]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18-75 years old
Undergoing minimally invasive lung cancer resection
Able to use smartphones and complete electronic questionnaires
Signed informed consent

Exclusion Criteria:

ECOG score > 1
Received neoadjuvant therapy
Previous lung resection surgery
Unable to exercise due to physical limitations
Continuous systemic corticosteroid use within 1 month before enrollment
Unresolved toxicity above Grade 1 from previous treatments
Significant comorbidities or medical history

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	No.2 Sunwen East Rd.	Zhongshan	Guangdong	China	528403

Sponsors and Collaborators

Zhongshan People's Hospital, Guangdong, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xiaojuan Yang, Nurse Practitioner, Zhongshan People's Hospital, Guangdong, China

ClinicalTrials.gov Identifier:

NCT05990946

Other Study ID Numbers:

K2022-285

First Posted:

Aug 14, 2023

Last Update Posted:

Aug 14, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Xiaojuan Yang, Nurse Practitioner, Zhongshan People's Hospital, Guangdong, China

Exercise Adherence

ePRO

Remote Monitoring

Postoperative Rehabilitation

Symptom Management

Additional relevant MeSH terms:

Lung Neoplasms

Postoperative Complications

Study Results

No Results Posted as of Aug 14, 2023