Clinical trial NCT05990946: 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
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Zhongshan People's Hospital, Guangdong, China
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 736
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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:

* conversions to open thoracotomy during surgery
* 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

Primary outcomes:
measure: Rehabilitation exercise adherence rate over 1 month after discharge
timeFrame: From the day of discharge to 30 days after discharge
Secondary outcomes:
measure: Post-discharge pulmonary complication rate
timeFrame: From the day of discharge to 30 days after discharge
measure: 30-day hospital readmission rate
timeFrame: From the day of discharge to 30 days after discharge
measure: Changes in symptom severity scores from discharge to 30 days
timeFrame: From the day of discharge to 30 days after discharge
measure: Patient satisfaction scores
timeFrame: From the day of discharge to 30 days after discharge
Other outcomes:
Locations:
city: Zhongshan
country: China
facility: No.2 Sunwen East Rd.
state: Guangdong
Study officials:
References: