NCT05501990

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 16, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 21, 2023

Status Verified

December 1, 2023

Enrollment Period

1.5 years

First QC Date

August 10, 2022

Last Update Submit

December 20, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Self-reported quality of life as assessed by ED-5Q-5L scale

    3 months

  • Psychological status as assessed by the HADS scale

    3 months

  • Symptom distress as assessed by the MD Anderson symptom scale

    3 months

Study Arms (1)

Health intervention based on intelligent applet

EXPERIMENTAL

Health interventions using electronic applet, including nutrition, psychology, and patient self-management components.

Behavioral: Health intervention based on intelligent applet

Interventions

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.

Health intervention based on intelligent applet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Equipped with specific devices (such as cardiac pacemaker);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital,Shanghai Jiao Tong University School of Medicine

Shanghai, 200025, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Lei Huang, PhD, MD

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Fellow; PI

Study Record Dates

First Submitted

August 10, 2022

First Posted

August 16, 2022

Study Start

July 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

December 21, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations