Application of Digital Therapeutic in Lung Cancer Whole Process Management
Conditions
Keywords
Digital therapeutic, Whole process management, Lung cancer, Patient follow-up
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.
Interventions
OTHERUHealth digital therapeutic
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.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 emergency treatment | 24 months after enrollment | The frequency of emergency treatment |
| The frequency of rehospitalization | 24 months after enrollment | The frequency of rehospitalization |
| 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 |
| Disease-free survival | 24 months after enrollment | — |
| Overall survival | 24 months after enrollment | — |
| The compliance of follow-up | 24 months after enrollment | The evaluation of follow-up compliance is based on the frequency of drop out |
Countries
China
Contacts
Primary ContactHao Long, MD
Outcome results
None listed