Lung Neoplasms, Non-Small Cell Lung CancerNCT05990946
Smartphone-based Remote Symptom Monitoring to Improve Postoperative Rehabilitation Exercise Adherence After Video-assisted Thoracic Surgery (VATS) for Lung Cancer
A study testing ePRO based Remote Symptom Management provide by a mobile phone app in people with Lung Neoplasms, Non-Small Cell Lung Cancer and Postoperative Complications, run by Zhongshan People's Hospital, Guangdong, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Neoplasms, Non-Small Cell Lung Cancer, Postoperative Complications, Patient Reported Outcome Measures
- What is being tested?
- ePRO based Remote Symptom Management provide by a mobile phone app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 736 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 30 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
No.2 Sunwen East Rd.
Zhongshan, Guangdong, 528403
Xiaojuan Yang, +86 0760-88823566, 1002381745@qq.com
About this study
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
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.
Read the 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 736 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.
Due to slower-than-expected recruitment, the DSMB recommended a review of trial progress. Before any unblinded between-group efficacy analysis, a pooled, blinded review of recruitment progress, data completeness, and outcome-data structure was conducted without treatment-group efficacy estimates. Following this blinded review, and before database lock or release of treatment codes, the protocol was amended to introduce one formal interim efficacy analysis and to add mean weekly exercise duration as a co-primary endpoint alongside 1-month exercise adherence. The amendment was approved by the Ethics Committee and the amended statistical analysis plan was finalized before the first formal unblinded between-group analysis. The formal interim analysis subsequently used a Lan-DeMets O'Brien-Fleming alpha-spending approach.
- Conditions
- Lung Neoplasms, Non-Small Cell Lung Cancer, Postoperative Complications, Patient Reported Outcome Measures, Telerehabilitation, Exercise Therapy
- Being tested
- ePRO based Remote Symptom Management provide by a mobile phone app
- Keywords
- Exercise Adherence, ePRO, Remote Monitoring, Postoperative Rehabilitation, Symptom Management
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ePRO based Remote Symptom Management provide by a mobile phone appDevice
Also called mobile phone app for Remote Symptom Management
Alerts are triggered if any of 5 core symptoms scored ≥4, prompting remote clinician feedback and guidance on symptom management. This is facilitated through the "Shuyu" mobile application, which serves as the platform for monitoring symptoms and communication.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Device: ePRO based Remote Symptom Management provide by a mobile phone app |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the day of discharge to 30 days after discharge
Mean weekly exercise duration over 1 month after discharge
Mean weekly exercise duration measured over the first 30 days post-discharge. This endpoint was added through a protocol amendment before the formal unblinded interim efficacy analysis. Interim testing used a Lan-DeMets O'Brien-Fleming alpha-spending approach.
Measured: From discharge to 30 days after discharge.
Secondary outcomes (4)
Post-discharge pulmonary complication rate
Measured: From the day of discharge to 30 days after discharge
30-day hospital readmission rate
Measured: From the day of discharge to 30 days after discharge
Changes in symptom severity scores from discharge to 30 days
Measured: From the day of discharge to 30 days after discharge
Patient satisfaction scores
Measured: From the day of discharge to 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Dec 2023
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung Neoplasms, Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 736 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan People's Hospital, Guangdong, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaojuan Yang, Zhongshan People's Hospital, Guangdong, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990946
- Sponsor's protocol ID
- K2022-285
- Status last verified
- Sep 2026
- First submitted
- 6 Aug 2023
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not available. The individual participant data collected in this study will not be shared with external researchers.
Publications
Yang X, Zhang Q, Ye C, Cheng Y, Wu J, Liang Y, Su J. Factors Influencing Symptom Severity at Discharge after Lobectomy and Sublobar Resection Through Video-assisted Thoracoscopic Surgery. Interdiscip Cardiovasc Thorac Surg. 2025 Aug 5;40(8):ivaf170. doi: 10.1093/icvts/ivaf170.
PubMed 40811025Su J, Ye C, Zhang Q, Liang Y, Wu J, Liang G, Cheng Y, Yang X. Impact of Remote Symptom Management on Exercise Adherence After Video-Assisted Thoracic Surgery for Lung Cancer in a Tertiary Hospital in China: Protocol for a Prospective Randomized Controlled Trial. JMIR Res Protoc. 2025 Jan 1;14:e60420. doi: 10.2196/60420.
PubMed 39610048