ClinicalTrials.gg
RecruitingNCT05990946Updated Sep 4, 2026

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

An interventional study of ePRO based Remote Symptom Management provide by a mobile phone app in Lung Neoplasms, Non-Small Cell Lung Cancer, Postoperative Complications and Patient Reported Outcome Measures, sponsored by Zhongshan People's Hospital, Guangdong, China. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-04.

Primary conditionCarcinoma, Non-Small-Cell LungRegistry: Lung NeoplasmsReclassifiedWhy we changed it
Registry
Lung Neoplasms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Carcinoma, Non-Small-Cell Lung
Why
  1. The study's listed conditions name Carcinoma, Non-Small-Cell Lung, a narrower term within Lung Neoplasms.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Zhongshan People's Hospital, Guangdong, China · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Dec 2023; still recruiting 2 years 11 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
736
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 1,878 studies in Carcinoma, Non-Small-Cell Lung with a site in China — 763 open to participants now, 986 under way, 203 of them phase 3. Carcinoma, Non-Small-Cell Lung · China.

Planned enrollment
100th of 1,592
736 · median 100
Started
2023
with 159 others
No phase
138 of 1,878
76 open now
Primary completion
2027-03
later than 526 of 985 live
Registered
1,176th of 1,878
by date

Among the 1,878 studies in Carcinoma, Non-Small-Cell Lung with a site in China, this one is the 100th largest by planned enrollment of the 1,592 interventional ones that give a count, is one of 160 that started in 2023, is one of 138 with no phase, reaches primary completion later than 526 of the 985 other live ones, and was the 1,176th registered.

Carcinoma, Non-Small-Cell Lung

7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.

Browse Carcinoma, Non-Small-Cell Lung studies →

Open to participants now

763 of the 1,878 studies in Carcinoma, Non-Small-Cell Lung with a site in China are open now. Recruiting first, the newest first:

758 more — sign in →

All 763 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 1,878 studies in Carcinoma, Non-Small-Cell Lung with a site in China, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

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

Browse trials for

Keywords

  • Exercise Adherence
  • ePRO
  • Remote Monitoring
  • Postoperative Rehabilitation
  • Symptom Management
04

In context

Carcinoma, Non-Small-Cell Lung Reclassified

7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.

This study's planned enrollment of 736 is above the median of 62 across 6,023 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Zhongshan People's Hospital, Guangdong, China is the lead sponsor of 11 studies on the registry; 8 are open to participants now.

Compared within Carcinoma, Non-Small-Cell Lung, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lung Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18-75 years old
  • preoperative clinical diagnosis or suspicion of resectable primary lung cancer
  • Able to use smartphones and complete electronic questionnaires
  • Signed

Exclusion criteria

Exclusion Criteria:

  • conversions to open thoracotomy during surgery
  • score > 1
  • Received therapy
  • Previous lung resection surgery
  • Unable to exercise due to physical limitations
  • Continuous systemic use within 1 month before enrollment
  • Unresolved toxicity above Grade 1 from previous treatments
  • Significant comorbidities or medical history
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

06

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
736 participants (estimated)

Study arms

  • Experimental
    Intervention Group

    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

  • No intervention
    Control Group

    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

  • DeviceePRO based Remote Symptom Management provide by a mobile phone app

    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

07

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From the day of discharge to 30 days after discharge

  2. 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.

    Time frame: From discharge to 30 days after discharge.

Secondary outcomes

  1. Post-discharge pulmonary complication rate

    Time frame: From the day of discharge to 30 days after discharge

  2. 30-day hospital readmission rate

    Time frame: From the day of discharge to 30 days after discharge

  3. Changes in symptom severity scores from discharge to 30 days

    Time frame: From the day of discharge to 30 days after discharge

  4. Patient satisfaction scores

    Time frame: From the day of discharge to 30 days after discharge

08

Study locations

1 of 1 sites recruiting
  • No.2 Sunwen East Rd.
    Zhongshan, Guangdong 528403, China
    Recruiting
09

References and documents

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 40811025 ↗
  • 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. PubMed 39610048 ↗

Individual participant data

Plan to share: No — Not available. The individual participant data collected in this study will not be shared with external researchers.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2023 (actual). Primary completion is estimated for Mar 2027, 39 months after the start.

Of 344 non-industry interventional studies with no phase under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 98. This study's planned 39 months is below that.

Counting every sponsor, half of 360 studies reached it within 51 months; a quarter within 26 and three quarters within 97.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 6, 2023
First posted
Aug 14, 2023
StartActual
Dec 1, 2023
Primary completionEst.
Mar 30, 2027
CompletionEst.
Jun 30, 2027
Last update
Sep 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05990946
Lead sponsor
Zhongshan People's Hospital, Guangdong, China
Responsible party
Xiaojuan Yang (Nurse Practitioner, Zhongshan People's Hospital, Guangdong, China) — Principal investigator
First posted
Aug 14, 2023
Start date
Dec 1, 2023
Primary completion
Mar 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Sep 4, 2026

Study contacts

Xiaojuan Yang
Contact
1002381745@qq.com
+86 0760-88823566

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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