Effects of Digital Therapeutic in Whole Process Management of Lung Cancer

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

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 Overview

• Status: Recruiting
• Conditions: Application of Digital Therapeutic in Lung Cancer Whole Process Management
• Intervention / Treatment: Other: UHealth digital therapeutic

• Study Type: Interventional
• Enrollment (Estimated): 900
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Hao Long, MD; Phone Number: +86-13802770989; Email: longhao@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-Sen University Cancer Center
      • Contact: Hao Long, MD; Phone Number: +86-13802770989; Email: longhao@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UHealth digital therapeutic group; The patients in this group will use UHealth application to monitor their symptoms and give medical advisement through digital methods.	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.
No Intervention: Regular follow-up group; The patients in this group will use paper-based follow-up to monitor their symptoms and give medical advisement in outpatient clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The quality of life after 6 months follow-up	The evaluation of quality of life is based on FACT questionnaire (Version 4.0)	From enrollment to 6 months after follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The score of anxiety/depression after 6 months follow-up	The evaluation of anxiety/depression is based on HADS questionnaire	From enrollment to 6 months after follow-up
The physical fitness score at the time of tumor progression	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 emergency treatment	The frequency of emergency treatment	24 months after enrollment
The frequency of rehospitalization	The frequency of rehospitalization	24 months after enrollment
The compliance of follow-up	The evaluation of follow-up compliance is based on the frequency of drop out	24 months after enrollment
Disease-free survival		24 months after enrollment
Overall survival		24 months after enrollment

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Publications and helpful links

General 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. Erratum In: J Clin Oncol. 2016 Jun 20;34(18):2198. J Clin Oncol. 2019 Feb 20;37(6):528.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: January 27, 2024
• First Posted (Actual): January 30, 2024

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Lung cancer; Digital therapeutic; Whole process management; Patient follow-up
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: A2023-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The participant data will be encrypted and masked before uploading.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No