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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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
No.2 Sunwen East Rd.
RECRUITING
Zhongshan
Contact Information
Primary
Xiaojuan Yang
1002381745@qq.com
+86 0760-88823566
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 736
Treatments
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.
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.
Sponsors
Leads: Zhongshan People's Hospital, Guangdong, China

This content was sourced from clinicaltrials.gov