Non-Small Cell Lung Cancer (NSCLC), Rehabilitation, Thoracic Surgery
Conditions
Keywords
Non-Small Cell Lung Cancer (NSCLC), Rehabilitation, Thoracic Surgery
Brief summary
This is a prospective, open-label, parallel-group, 1:1 randomized controlled trial evaluating whether a wireless wearable mobile monitoring device combined with a digital rehabilitation program improves pulmonary function at 90 days postoperatively in patients undergoing curative-intent lobectomy or segmentectomy for non-small cell lung cancer (NSCLC). Eligible participants will be randomized to either the intervention group or the control group. Both groups receive standard postoperative rehabilitation education. The intervention group additionally receives a wearable device (chest patch or wristband) for continuous monitoring of SpO₂, heart rate, respiratory rate, and physical activity, along with a smartphone-based digital rehabilitation program including individualized exercise prescriptions (aerobic, resistance, and inspiratory muscle training), daily symptom diaries, and remote feedback with threshold-triggered alerts for up to 90 days after discharge. The control group receives standard rehabilitation education with routine follow-up. The primary endpoint is the between-group difference in FEV1% predicted at postoperative day 90, analyzed using ANCOVA adjusted for baseline FEV1% predicted. Secondary endpoints include FVC% predicted, 6-minute walk distance, daily step count, SpO₂ \<90% time burden, quality of life (EORTC QLQ-C30/LC13, mMRC), 90-day readmission and emergency visit rates, and safety outcomes. A total of 126 participants (63 per group) will be enrolled. The study is being conducted at West China Hospital of Sichuan University from June 2026 to October 2027.
Detailed description
Study Design This is a prospective, single-center, parallel-group, 1:1 randomized controlled superiority trial conducted at West China Hospital of Sichuan University. Enrollment is planned from June 2026 to August 2027, with final data analysis by October 2027. The study protocol has been approved by the local ethics committee (Approval No. 2025-2643, dated December 30, 2025). Study Population We will enroll 126 patients aged 18-85 years with histopathologically confirmed primary NSCLC who have undergone elective curative-intent lobectomy or segmentectomy. Eligible participants must be planned for discharge between postoperative days 2-7, clinically stable for home-based rehabilitation, and able to operate a smartphone and wearable devices independently or with caregiver assistance. Randomization and Blinding Participants are randomized 1:1 using a central web-based block randomization system. This is a single-blind trial: participants and rehabilitation instructors are aware of group assignment, but outcome assessors (pulmonary function technicians, 6MWD operators) and statisticians are blinded to group allocation. Intervention Control group receives standard postoperative rehabilitation education, including breathing exercises and progressive walking recommendations, with routine follow-up at 1 month and 3 months. Intervention group receives, in addition to standard education: (1) a wireless wearable patch or wristband for continuous monitoring of SpO₂, single-lead ECG, respiratory rate, and activity data; (2) a smartphone-based digital rehabilitation program with individualized exercise prescriptions (aerobic, resistance, and inspiratory muscle training) and daily symptom diaries; and (3) remote feedback and threshold-triggered alerts (e.g., SpO₂ \<90% for \>1 minute) with graded clinical responses. Follow-up and Assessments The observation period spans from discharge to postoperative day 90. Assessments include pulmonary function tests (FEV1%, FVC%, FEV1/FVC), 6-minute walk distance, quality of life (EORTC QLQ-C30/LC13, mMRC), continuous physiological monitoring (intervention group only), adherence metrics, and healthcare utilization (readmissions, ED visits, complications). Primary Endpoint The primary endpoint is the FEV1% predicted at postoperative day 90 (±14 days), analyzed by ANCOVA with baseline FEV1% predicted as covariate. Sample Size With two-sided α=0.05, 80% power, an expected between-group difference of 7% in FEV1% predicted, and a pooled standard deviation of 12%, 53 participants per group are required. Accounting for 18% dropout, the final sample size is 126 (63 per group). Statistical Analysis Primary analysis will be performed on the intention-to-treat population using ANCOVA. Secondary continuous endpoints will be analyzed using ANCOVA or repeated-measures ANOVA; categorical endpoints using chi-square or Fisher's exact test. Safety outcomes will be summarized descriptively. A two-sided p-value \<0.05 is considered statistically significant. Safety and Data Quality Adverse events are graded per CTCAE v5.0. Serious adverse events are reported within 24 hours. All study personnel follow standardized operating procedures, and electronic data capture with dual entry and logic checks ensures data quality. Ethics and Dissemination The study is conducted in accordance with the Declaration of Helsinki and Chinese regulations. Written informed consent will be obtained from all participants. Results will be published regardless of outcome.
Interventions
Wireless wearable chest patchs or wristband integrating SpO₂, single-lead ECG, respiratory rate, and accelerometer sensors for continuous monitoring of vital signs and physical activity during daily living.
BEHAVIORALDigital Postoperative Rehabilitation Program
A 90-day home-based digital rehabilitation program delivered via smartphone application, including individualized exercise prescriptions (aerobic walking, resistance training with elastic bands, inspiratory muscle training), daily symptom diaries (cough, sputum, dyspnea), and remote feedback with threshold-triggered alerts and weekly telehealth follow-ups.
OTHERStandard Postoperative Rehabilitation Education
Standardized verbal and written postoperative rehabilitation education including breathing exercises (abdominal breathing, pursed-lip breathing, effective coughing), progressive walking recommendations, and routine outpatient follow-up at 1 month and 3 months per institutional practice.
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥18 and ≤85 years * Histopathologically confirmed primary non-small cell lung cancer (NSCLC) who have undergone elective curative-intent lobectomy or segmentectomy * Planned discharge between postoperative day 2 and day 7, and judged by the investigator to be clinically stable and suitable for home-based rehabilitation * Able to operate a smartphone application and wearable devices independently or with caregiver assistance * Willing and able to provide written informed consent
Exclusion criteria
* Pre-existing long-term home oxygen therapy, or severe resting respiratory dysfunction * Concurrent severe, uncontrolled cardiovascular disease, severe hepatic insufficiency, or severe renal insufficiency * Other diseases or conditions that significantly affect motor function or compliance * Known or suspected contact allergy to medical adhesives or materials used in the wearable devices * Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FEV1% Predicted at Postoperative Day 90 | Postoperative day 90 (±14 days) | Forced expiratory volume in 1 second (FEV1) as a percentage of predicted value, measured by spirometry according to ATS/ERS standards. The best value from at least three acceptable maneuvers is recorded. The between-group difference is analyzed using ANCOVA with baseline FEV1% predicted as covariate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FVC% Predicted at Postoperative Day 90 | Postoperative day 90 (±14 days) | Forced vital capacity (FVC) as a percentage of predicted value, measured by spirometry at postoperative day 90. |
| FEV1/FVC Ratio at Postoperative Day 90 | Postoperative day 90 (±14 days) | Ratio of FEV1 to FVC, measured by spirometry at postoperative day 90. |
| 6-Minute Walk Distance at Postoperative Day 90 | Postoperative day 90 (±14 days) | Total walking distance (in meters) during a 6-minute walk test performed in a 30-meter corridor by a blinded assessor according to standardized protocols. |
| Daily Step Count | Continuous from discharge to postoperative day 90 (intervention group only) | Mean daily step count derived from the accelerometer of the wearable device, calculated as the average over the 90-day post-discharge period. |
| Moderate-to-Vigorous Physical Activity (MVPA) Duration | Continuous from discharge to postoperative day 90 (intervention group only) | Daily minutes of moderate-to-vigorous physical activity derived from the accelerometer of the wearable device. |
| Time Proportion with SpO₂ Below 90% | Continuous from discharge to postoperative day 90 (intervention group only) | Percentage of total monitoring time with SpO₂ \<90% during the 90-day post-discharge period. |
| Mean SpO₂ and Lowest SpO₂ | Continuous from discharge to postoperative day 90 (intervention group only) | Mean oxygen saturation (SpO₂) and the lowest recorded SpO₂ value during the 90-day post-discharge period. |
| EORTC QLQ-C30 Global Health Status Score | Baseline (pre-discharge) and postoperative day 90 | European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) global health status and functional scale scores at postoperative day 90, compared to baseline. |
| EORTC QLQ-LC13 Lung Cancer Module Scores | Baseline (pre-discharge) and postoperative day 90 | European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13-item module (EORTC QLQ-LC13) domain scores assessing lung cancer-specific symptoms at postoperative day 90. |
| mMRC Dyspnea Scale Score | Baseline (pre-discharge) and postoperative day 90 | Modified Medical Research Council (mMRC) dyspnea scale score (0-4) assessed at postoperative day 90. |
| 90-Day Unplanned Readmission Rate | Within 90 days after surgery | Proportion of participants with any unplanned all-cause hospital readmission within 90 days after the index surgery. |
| 90-Day Emergency Department Visit Rate | Within 90 days after surgery | Proportion of participants with any unplanned emergency department visit within 90 days after the index surgery. |
| 90-Day Pulmonary Complication Rate | Within 90 days after surgery | Proportion of participants developing pulmonary complications (e.g., pneumonia, atelectasis, prolonged air leak) within 90 days after surgery. |
| Days Alive and Out of Hospital Within 90 Days | Within 90 days after surgery | Number of days alive and not hospitalized (in hospital or rehabilitation facility) during the 90-day post-surgery period. |
| Wearable Device Adherence Rate | From discharge to postoperative day 90 (intervention group only) | Proportion of valid wear days, defined as days with ≥20 hours of monitoring data from the wearable device during the 90-day post-discharge period. |
| Incidence of Device-Related Skin Reactions | From discharge to postoperative day 90 | Proportion of participants experiencing device-related skin reactions (e.g., erythema, pruritus, rash, contact dermatitis, skin breakdown) graded by severity per CTCAE v5.0. |
| Incidence of Any Adverse Event and Serious Adverse Event | From enrollment through postoperative day 90 | Proportion of participants experiencing at least one adverse event (AE) or serious adverse event (SAE) during the study period. AEs are graded per CTCAE v5.0; SAEs are defined per ICH criteria. |
Countries
China
Contacts
CONTACTXuelei ma
Outcome results
None listed