Increase Understanding and Safety of Treatment

Oncology Clinical Trial

Official title:

A Randomized Controlled Trial to Explore Whether the Patients With Cancers on Clinical Trials Can Use the Health Insurance APP-My Health Bank to Increase Understanding and Safety of Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05242341
• Other study ID #: 202106191RINA
• Status: Recruiting
• Phase: N/A
• Start date: January 14, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: February 2022
• Source: National Taiwan University Hospital
• Contact: Yu Hsuan Cheng
• Phone: (+886)988085210
• Email: ann3032004[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Purpose: The purpose of this study is to use a randomized controlled trial to explore whether the patients with cancers on clinical trials can use the Health Insurance APP-My Health Bank to increase understanding and safety of treatment. It is of hope that the results of this study can help confirm whether cancer patients participate in clinical trials, learn to use the " Health Insurance APP-My Health Bank ", can increase the safety of treatment, including the understanding of the disease , the understanding of the lab data, and the communication about contraindications and concurrent use of medications. The results of this research will help clinical healthcare professionals promote the use of My Health Bank, and improve the safety of clinical trials, as well as to increase the communications between patients, doctors and nurses.

Methods: In this study, cancer patients (hematology-oncology patients are the priority invitations) were invited to participate in clinical trials in the outpatient and inpatient units. After explaining that they agreed to participate in the study, they were randomlyassigned to the experimental group and the control group. Intervention includes teach the subjects one-on-one to use the "My Health Bank" for 30 minutes (such as download, register, test, find information, etc.), and provide pre-recorded 1-minute instructional videos for viewing when needed at home. The intervention group also accepts to follow the use of My Health Bank app at home every two weeks for a period of two months. Both groups will receive pre- and post-evaluations, including knowledge of the disease, understanding of lab data, and knowledge of medication safety (prohibited medicines and concomitant medications). Post-intervention, the intervention group will also be evaluated on the "Satisfaction and Quality of Technology Use" of My Health Bank APP. Data analysis is expected to adopt Intention-to-treat analysis (ITT) method to compare the differences before and after intervention between the two groups to verify teach patients the clinical feasibility of using a My Health Bank and the effect of assisting patient care.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Over the age of 20, the subject voluntarily accepts this study and signs the consent form

• Participants in clinical trials of hematological tumor-related diseases (have been or are participating in it)

• Need to be literate and can communicate in Chinese and Taiwanese

• Have a mobile phone or electronic device to download the my health bank APP and be willing to cooperate with it for at least two months of continuous use

Exclusion Criteria:

• I have downloaded the "my health bank APP" and use well

• Cognitive impairment diseases (e.g. dementia)

• The clinical trial protocol that originally participated in that it is not allowed to articipate in other interventional studies.

Related Conditions & MeSH terms

• Hematology
• Neoplasms
• Oncology

Intervention

Behavioral:
• application(APP) teaching
Teaching the use of the APP

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug safety and knowledge of diseases and app satisfaction	The Questionnaire include two scale, the first one is the scale of drug safety and knowledge of diseases , the minimum score is 8 points and the maximum is 40 points, higher scores mean a better outcome; the second scale is for app satisfaction, the minimum score is 0 point and the maximum is 55 points, higher scores mean a better outcome.	2 months