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

Primary Purpose

Lung Neoplasms, Non-Small Cell Lung Cancer, Postoperative Complications, Patient Reported Outcome Measures

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

ePRO based Remote Symptom Management

About this trial

This is an interventional supportive care trial for Lung Neoplasms, Non-Small Cell Lung Cancer focused on measuring Exercise Adherence, ePRO, Remote Monitoring, Postoperative Rehabilitation, Symptom Management

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

No.2 Sunwen East Rd.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Rehabilitation exercise adherence rate over 1 month 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

30-day hospital readmission rate

Changes in symptom severity scores from discharge to 30 days

Patient satisfaction scores

Full Information

NCT ID

NCT05990946

First Posted

August 6, 2023

Last Updated

August 6, 2023

Sponsor

Zhongshan People's Hospital, Guangdong, China

1. Study Identification

Unique Protocol Identification Number

NCT05990946

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2023 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhongshan People's Hospital, Guangdong, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Neoplasms, Non-Small Cell Lung Cancer, Postoperative Complications, Patient Reported Outcome Measures, Telerehabilitation, Exercise Therapy

Keywords

Exercise Adherence, ePRO, Remote Monitoring, Postoperative Rehabilitation, Symptom Management

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

224 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Experimental

Arm Description

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

Intervention Type

Procedure

Intervention Name(s)

ePRO based Remote Symptom Management

Other Intervention Name(s)

Symptom Management

Intervention Description

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

Primary Outcome Measure Information:

Title

Rehabilitation exercise adherence rate over 1 month after discharge

Description

Rehabilitation exercise adherence rate over 1 month after discharge, defined as the proportion of patients completing the prescribed outpatient exercise regimen.

Time Frame