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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05501990
• Other study ID #: RJODLH-001
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: Ruijin Hospital
• Contact: Lei Huang, PhD, MD
• Phone: 0086 021 64370045
• Email: huangleizhenting[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
China	Ruijin Hospital,Shanghai Jiao Tong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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