Study on the Accessibility and Feasibility of Intelligent Applet for Health Intervention of Cancer Patients

In the 5G era with the revolutionary improvement of network speed, digital medical care has brought great convenience to health services. There is a lack of mobile medical data on cancer care worldwide. We designed an applet based on mobile intelligent electronic devices with a doctor-patient dual interface for the perioperative management of cancer patients and verified its applicability in the general population. This study aims to specifically improve the applet according to the characteristics of cancer patients, use it to accurately manage and intervene cancer patients, and establish a rapid doctor-patient communication platform, hoping to improve prognosis.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Health intervention based on intelligent applet

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lei Huang, PhD, MD; Phone Number: 0086 021 64370045; Email: huangleizhenting@126.com

Study Locations

• China
  • Shanghai, China, 200025
    • Recruiting
    • Ruijin Hospital,Shanghai Jiao Tong University School of Medicine
    • Contact: Lei Huang, PhD, MD; Phone Number: 0086 021 64370045; Email: huangleizhenting@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Sign and date informed consent;
• Commit to abide by the research procedures and cooperate with the implementation of the whole research process ;
• Can adhere to and cooperate with research intervention;
• Tumor patients;
• Patients/family members can use smart phones to access the Internet;
• Patients/family members have sufficient cognitive and reading ability;
• No mental illness;
• No serious visual impairment

Exclusion Criteria:

• Equipped with specific devices (such as cardiac pacemaker);
• Those who do not meet the conditions listed in the inclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Health intervention based on intelligent applet; Health interventions using electronic applet, including nutrition, psychology, and patient self-management components.	Behavioral: Health intervention based on intelligent applet; Patients are jointly managed by a MDT team based on the applet. The supportive intervention based on the applet mainly includes three parts: Nutrition, psychology, and patient management which includes four main parts: Cancer patient education, self-management, patient community, and real-time communication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of the applet by cancer patients as assessed by questionnaire	Investigated by a questionnaire with 33 questions, and compared with other mobile medical methods to explore the accessibility	3 months
Acceptability of the applet by medical oncology staff as assessed by questionnaire	The questionnaire includes 22 questions, collecting information on attitude feedback, time input, and training cost of medical staff using the mobile medical applet	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported quality of life as assessed by ED-5Q-5L scale	EQ-5D-5L is a set of standardized scales for measuring health status, including 5 dimensions (1-5 points for each dimension) and a VAS for overall assessment of health status. Developed by the European Society for quality of life, it can provide a simple and universal health measurement method for clinical and economic evaluation.	3 months
Psychological status as assessed by the HADS scale	Hospital Anxiety and Depression Scale (HADS): A self screening questionnaire composed of 7 anxiety subscales and 7 depression subscales. The total score of each subscale is between 0 and 21. The higher the total score, the more serious the anxiety or depression.	3 months
Symptom distress as assessed by the MD Anderson symptom scale	Symptom distress is assessed with MD Anderson symptom scale, which is composed of 13 symptom severity and 6 symptom interference subscales. It is used to assess the interference of symptoms to patients' daily life. The item scores range from 1 to 10. The higher the average score, the more serious the symptom.	3 months

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Principal Investigator: Lei Huang, PhD, MD, Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 10, 2022
• First Submitted That Met QC Criteria: August 12, 2022
• First Posted (Actual): August 16, 2022

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: RJODLH-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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