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

Sponsor
Ruijin Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05501990
Collaborator
(none)
800
1
1
49
16.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Health intervention based on intelligent applet
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
800 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Study on the Accessibility and Feasibility of Intelligent Applet for Health Intervention of Cancer Patients
Actual Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Oct 31, 2024
Anticipated Study Completion Date :
Oct 31, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Acceptability of the applet by cancer patients as assessed by questionnaire [3 months]

    Investigated by a questionnaire with 33 questions, and compared with other mobile medical methods to explore the accessibility

  2. Acceptability of the applet by medical oncology staff as assessed by questionnaire [3 months]

    The questionnaire includes 22 questions, collecting information on attitude feedback, time input, and training cost of medical staff using the mobile medical applet

Secondary Outcome Measures

  1. Self-reported quality of life as assessed by ED-5Q-5L scale [3 months]

    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.

  2. Psychological status as assessed by the HADS scale [3 months]

    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. Symptom distress as assessed by the MD Anderson symptom scale [3 months]

    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.

  4. Treatment compliance as assessed by MMAS-8 scale [3 months]

    The MMAS-8 scale measures self-reported treatment compliance. This is a self-reported 8-item scale. The response category of each item is yes or no, and the last item is a 5-point Likert response. Higher responses indicate better compliance.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ruijin Hospital,Shanghai Jiao Tong University School of Medicine Shanghai China 200025

Sponsors and Collaborators

  • Ruijin Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
lei huang, Research Associate Fellow; PI, Ruijin Hospital
ClinicalTrials.gov Identifier:
NCT05501990
Other Study ID Numbers:
  • RJODLH-001
First Posted:
Aug 16, 2022
Last Update Posted:
Aug 16, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 16, 2022