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Trial Title:
Effects of Digital Therapeutic in Whole Process Management of Lung Cancer
NCT ID:
NCT06230445
Condition:
Application of Digital Therapeutic in Lung Cancer Whole Process Management
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Digital therapeutic
Whole process management
Lung cancer
Patient follow-up
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
UHealth digital therapeutic
Description:
UHealth digital therapeutic is an application that patients can report their symptoms. If
the contents that patients fill in reach the threshold, UHealth application will
automatic report to doctor and the doctor will give medical advisement through UHealth
digital therapeutic application.
Arm group label:
UHealth digital therapeutic group
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Hao Long, MD
Phone:
+86-13802770989
Email:
longhao@sysucc.org.cn
Start date:
June 1, 2023
Completion date:
September 1, 2028
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06230445