Effects of Digital Therapeutic in Whole Process Management of Lung Cancer

Phase 3

Recruiting

• Conditions: Application of Digital Therapeutic in Lung Cancer Whole Process Management
• Interventions: Other: UHealth digital therapeutic

• Registration Number: NCT06230445
• Lead Sponsor: Sun Yat-sen University

Brief Summary

This trial will randomize patients into two groups, the treatment group will use the digital therapeutic application named 'UHealth' for the whole process management and the control group will use regular follow-up. The trial aims to look into the difference between quality of life, anxiety/depression index, emergency treatment times, hospital admission rate, treatment compliance, OS, DFS and follow-up cost.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2023-08-31
• Study First Submitted QC: 2024-01-27
• Study First Posted: 2024-01-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26
• Primary Completion: 2026-03-01
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

• Patients with histologically or cytologically confirmed lung cancer;
• Patients have received surgery, neoadjuvant therapy, adjuvant therapy, radiotherapy or other chemotherapy, such as cytotoxic chemotherapy, targeted therapy and immunotherapy;
• ECOG (Performance status) 0-1;
• Patients aged > 18 years and < 70 years;
• The patients themselves or their family members are familiar with mobile and internet;

Exclusion Criteria

• Patients have disease progression in the screening period;
• Patients with symptomatic brain metastasis;
• Patients with dementia, schizophrenia or other psychological diseases that may affect the cognitive behavior;
• Other medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information;
• Women who are pregnant or in the period of breastfeeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UHealth digital therapeutic group	UHealth digital therapeutic	The patients in this group will use UHealth application to monitor their symptoms and give medical advisement through digital methods.

Primary Outcome Measures

Name	Time	Method
The quality of life after 6 months follow-up	From enrollment to 6 months after follow-up	The evaluation of quality of life is based on FACT questionnaire (Version 4.0)

Secondary Outcome Measures

Name	Time	Method
The physical fitness score at the time of tumor progression	From enrollment to the time of tumor progression (up to 72 months)	The physical fitness score at the time of tumor progression
The frequency of rehospitalization	24 months after enrollment	The frequency of rehospitalization
The compliance of follow-up	24 months after enrollment	The evaluation of follow-up compliance is based on the frequency of drop out
Disease-free survival	24 months after enrollment
Overall survival	24 months after enrollment
The score of anxiety/depression after 6 months follow-up	From enrollment to 6 months after follow-up	The evaluation of anxiety/depression is based on HADS questionnaire
The frequency of emergency treatment	24 months after enrollment	The frequency of emergency treatment

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China