Clinical trial NCT06230445: Effects of Digital Therapeutic in Whole Process Management of Lung Cancer
Official title: A Phase 3, Randomized, Open-label Trial of Digital Therapeutic vs Regular Follow-up in Whole Process Management of Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Application of Digital Therapeutic in Lung Cancer Whole Process Management
Keywords: Digital therapeutic
Whole process management
Lung cancer
Patient follow-up
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: The quality of life after 6 months follow-up
timeFrame: From enrollment to 6 months after follow-up
Secondary outcomes:
measure: The score of anxiety/depression after 6 months follow-up
timeFrame: From enrollment to 6 months after follow-up
measure: The physical fitness score at the time of tumor progression
timeFrame: From enrollment to the time of tumor progression (up to 72 months)
measure: The frequency of emergency treatment
timeFrame: 24 months after enrollment
measure: The frequency of rehospitalization
timeFrame: 24 months after enrollment
measure: The compliance of follow-up
timeFrame: 24 months after enrollment
measure: Disease-free survival
timeFrame: 24 months after enrollment
measure: Overall survival
timeFrame: 24 months after enrollment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References:
citation: Basch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, Rogak L, Bennett AV, Dueck AC, Atkinson TM, Chou JF, Dulko D, Sit L, Barz A, Novotny P, Fruscione M, Sloan JA, Schrag D. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. J Clin Oncol. 2016 Feb 20;34(6):557-65. doi: 10.1200/JCO.2015.63.0830. Epub 2015 Dec 7.
citation: Basch E, Deal AM, Dueck AC, Scher HI, Kris MG, Hudis C, Schrag D. Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment. JAMA. 2017 Jul 11;318(2):197-198. doi: 10.1001/jama.2017.7156.
citation: Dai W, Feng W, Zhang Y, Wang XS, Liu Y, Pompili C, Xu W, Xie S, Wang Y, Liao J, Wei X, Xiang R, Hu B, Tian B, Yang X, Wang X, Xiao P, Lai Q, Wang X, Cao B, Wang Q, Liu F, Liu X, Xie T, Yang X, Zhuang X, Wu Z, Che G, Li Q, Shi Q. Patient-Reported Outcome-Based Symptom Management Versus Usual Care After Lung Cancer Surgery: A Multicenter Randomized Controlled Trial. J Clin Oncol. 2022 Mar 20;40(9):988-996. doi: 10.1200/JCO.21.01344. Epub 2022 Jan 7.