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Recruiting NCT06230445

Effects of Digital Therapeutic in Whole Process Management of Lung Cancer

Phase III Interventional Application of Digital Therapeutic in Lung Cancer Whole Process Management

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: UHealth digital therapeutic.
Who it may be relevant to
Registry conditions: Application of Digital Therapeutic in Lung Cancer Whole Process Management. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3, Randomized, Open-label Trial of Digital Therapeutic vs Regular Follow-up in Whole Process Management of Lung Cancer

Overview

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

  • Other UHealth 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.

Primary outcome measures

  • The quality of life after 6 months follow-up [Time frame: From enrollment to 6 months after follow-up]
Secondary outcome measures (7)
  • The score of anxiety/depression after 6 months follow-up [Time frame: From enrollment to 6 months after follow-up]
  • The physical fitness score at the time of tumor progression [Time frame: From enrollment to the time of tumor progression (up to 72 months)]
  • The frequency of emergency treatment [Time frame: 24 months after enrollment]
  • The frequency of rehospitalization [Time frame: 24 months after enrollment]
  • The compliance of follow-up [Time frame: 24 months after enrollment]
  • Disease-free survival [Time frame: 24 months after enrollment]
  • Overall survival [Time frame: 24 months after enrollment]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

China · 1 center
  • Sun Yat-sen University Cancer Center — Guangzhou

Publications

  • 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. PMID 26644527
  • 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. PMID 28586821
  • 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):9 PMID 34995100

Identifiers

NCT: NCT06230445 · A2023-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗