NCT05990946

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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
736

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Dec 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Dec 2023Jun 2027

First Submitted

Initial submission to the registry

August 6, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

September 4, 2026

Status Verified

September 1, 2026

Enrollment Period

3.3 years

First QC Date

August 6, 2023

Last Update Submit

September 1, 2026

Conditions

Lung Neoplasms, Non-Small Cell Lung CancerPostoperative ComplicationsPatient Reported Outcome MeasuresTelerehabilitationExercise Therapy

Keywords

Exercise AdherenceePRORemote MonitoringPostoperative RehabilitationSymptom Management

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    From discharge to 30 days after discharge.

Secondary Outcomes (4)

  • 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

Study Arms (2)

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.

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.

Interventions

ePRO based Remote Symptom Management provide by a mobile phone appDEVICE

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.

Also known as: mobile phone app for Remote Symptom Management
Intervention Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

No.2 Sunwen East Rd.

Zhongshan, Guangdong, 528403, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 40811025DERIVED

  • Su 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.

    PMID: 39610048DERIVED

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungPostoperative Complications

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Xiaojuan Yang

CONTACT

+86 0760-888235661002381745@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse Practitioner

Study Record Dates

First Submitted

August 6, 2023

First Posted

August 14, 2023

Study Start

December 1, 2023

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

September 4, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Not available. The individual participant data collected in this study will not be shared with external researchers.

Locations

CN(1)