NCT05990946Recruiting
Smartphone-based Remote Symptom Monitoring to Improve Postoperative Rehabilitation Exercise Adherence After Video-assisted Thoracic Surgery (VATS) for Lung Cancer
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
Source: ClinicalTrials.gov · Last updated 4 Sept 2026
Brief summary (registry, in English)
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. Due to slower-than-expected recruitment, an interim analysis was introduced through a protocol amendment. Before any unblinded between-group efficacy analysis, a blinded review of recruitment progress, data completeness, and outcome-data structure was conducted. Mean weekly exercise duration was subsequently added as a co-primary endpoint to complement the threshold-based exercise adherence outcome. The amendment and revised interim statistical framework were approved by the Ethics Committee before the formal interim analysis and incorporated into the updated study record.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 736 (estimated)
- First submitted
- 6 Aug 2023
- Start date
- 1 Dec 2023
- Primary completion date
- 30 Mar 2027
- Lead sponsor
- Zhongshan People's Hospital, Guangdong, China
- Diseases
- Lung cancer
- NCT number
- NCT05990946
What you commit to
- Study type: Interventional
- Planned participants: 736
- From 1 Dec 2023 to the primary completion date, 30 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- conversions to open thoracotomy during surgery
- Received neoadjuvant therapy
- Previous lung resection surgery
- Continuous systemic corticosteroid use within 1 month before enrollment
- Unresolved toxicity above Grade 1 from previous treatments
Other
- ECOG score \> 1
- Unable to exercise due to physical limitations
- Significant comorbidities or medical history
Who the study is looking for
- Age 18-75 years old
- preoperative clinical diagnosis or suspicion of resectable primary lung cancer
- Able to use smartphones and complete electronic questionnaires
- Signed informed consent
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| No.2 Sunwen East Rd. Coordinator of this site? Confirm its status | Zhongshan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.