NCT06230445RecruitingPhase 3
A Phase 3, Randomized, Open-label Trial of Digital Therapeutic vs Regular Follow-up in Whole Process Management of Lung Cancer
Sun Yat-sen University1 site in 1 country900 target enrollmentStarted: June 1, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 900
- Locations
- 1
- Primary Endpoint
- The quality of life after 6 months follow-up
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
The quality of life after 6 months follow-up
Time Frame: From enrollment to 6 months after follow-up
The evaluation of quality of life is based on FACT questionnaire (Version 4.0)
Secondary Outcomes
- The physical fitness score at the time of tumor progression(From enrollment to the time of tumor progression (up to 72 months))
- The frequency of rehospitalization(24 months after enrollment)
- The compliance of follow-up(24 months after enrollment)
- 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 frequency of emergency treatment(24 months after enrollment)
Investigators
Hao Long
Prof.
Sun Yat-sen University
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 3
Evaluate Efficacy and Safety of Oral SHR0302 in Subjects Aged 12 Years and Older With Moderate to Severe Atopic DermatitisAtopic DermatitisNCT04875169Reistone Biopharma Company Limited336
Completed
Phase 3
Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 2)Hepatitis CNCT01297270Boehringer Ingelheim658
Completed
Phase 3
To Study Generic Estradiol 10 mcg Vaginal Tablets in the Treatment of Vulvar and Vaginal Atrophy in Post Menopausal Women.Vulvar and Vaginal AtrophyNCT02668796Glenmark Pharmaceuticals Ltd. India522
Completed
Phase 3
Effectiveness of Etanercept for Idiopathic Pneumonia Syndrome Following Stem Cell Transplantation (BMT CTN 0403)Idiopathic Pneumonia SyndromePneumoniaNCT00421174National Heart, Lung, and Blood Institute (NHLBI)37
Completed
Phase 3
A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) InhibitorsUlcerative ColitisNCT02163759Hoffmann-La Roche358