Using a digital app to manage lung cancer treatment
A Phase 3, Randomized, Open-label Trial of Digital Therapeutic vs Regular Follow-up in Whole Process Management of Lung Cancer
This study is testing if a digital app can help lung cancer patients manage their treatment better than just regular follow-up care.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 900 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06230445 on ClinicalTrials.gov |
What this trial studies
This trial randomizes lung cancer patients into two groups: one using the UHealth digital therapeutic application for comprehensive management and the other receiving standard follow-up care. The study aims to evaluate differences in quality of life, anxiety and depression levels, emergency treatment times, hospital admission rates, treatment compliance, overall survival, disease-free survival, and follow-up costs. By comparing these outcomes, the trial seeks to determine the effectiveness of digital therapeutics in enhancing lung cancer management.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with confirmed lung cancer who have undergone various treatments and are comfortable using mobile technology.
Not a fit: Patients with disease progression, symptomatic brain metastasis, or significant cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life and treatment outcomes for lung cancer patients.
How similar studies have performed: Other studies have shown promising results with digital therapeutics in chronic disease management, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Hao Long, MD
- Email: longhao@sysucc.org.cn
- Phone: +86-13802770989
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.