Health Technologies Readiness in Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

The Degree of Health Technologies Readiness Amongst Patients With Suspected Breast Cancer Using the READHY-tool

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04745117
• Other study ID #: 21/4657
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: August 31, 2021

Study information

• Verified date: March 2023
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to investigate the degree of Health Technologies Readiness amongst patients with suspected breast cancer using the READHY-tool.

Description:

Health information, patient education, and self-management (health information and advice) tools are increasingly being made available to adults with different health conditions, either through internet-based health and mobile health digital information technologies (1). At the department of plastic surgery, there has, for several years, been a transition to digital solutions when delivering information to patients. Patient information now consists of web-sites, apps and videos available for the patients to use when they seek information about their disease and their treatment options. From a care-givers perspective, the increased amount of information available is positive, but can these patients cope with so much information being available digitally instead of information face-to-face or by paper? Despite the rapid change from analogue informatics to digital solutions, we do not know a lot about our patients' readiness for such a change. There is an increasing amount of studies on the subject, but no recent study on readiness for digital solutions among this patient group, patients with suspected breast cancer. That is what this study is hoping to achieve with this study. The plan is to use a relatively new tool called "READHY" to assess the health technology readiness amongst breast cancer patients. The tool consists of 70 questions, and the results will enable grouping of these patients according to their health technology readiness.

This study is a cross-sectional study where participants fill out a single questionnaire at first contact with the out-patient clinic. There will not be any follow-up.

The project is planned to start at 01.03.2021 and run for six months with termination at 30.09.21.

A clinical statistician was consulted regarding power and sample size. No power analysis was performed due to the nature of the study. In accordance with previous studies with similar methods, a convenience sample was chosen. 250 participants will be included over six consecutive months (2,3).

All patient-reported data will be handled through the secure server solution provided by OPEN Region of Southern Denmark. Additional data will be kept in the secure server Sharepoint, provided by Odense University Hospital.

The project complies with The General Data Protection Regulation act (databeskyttelsesforordningen) and the Danish Data Protection act (databeskyttelsesloven).

The study is in line with the Helsinki-declaration. Participation is by individuals capable of giving informed consent.

There are no personal gains for our participants, but in the longer perspective, the information gathered will enable physicians to better understand the eHealth literacy in this patient group. This will, in turn, help to improve the way the patients arre informed about their disease, treatment and options.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients referred to our department with suspected breast cancer.

• Ability to understand the aim of the study and to give consent. Being able to understand Danish at the level required to answer the questionnaires.

Exclusion Criteria:

• Danish skills that are insufficient for understanding and filling out the READHY-questionnaire in Danish.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• READHY - questionnaire
The READHY tool consists of 70 questions divided into three sections, one with a focus on eHealth literacy, one on self-management and one on the social context. The READHY consists of the eHealth Literacy Questionnaire (eHLQ) that includes seven scales, supplemented with four scales from the Health Education Impact Questionnaire (heiQ) and two scales from the Health Literacy Questionnaire (HLQ). The READHY tool has been validated. Each question presented to the participant as a statement and scored on a 4-point rating, from 1=strongly disagree to 4=strongly agree. The overall score of each scale was calculated as the mean score of the 4-6 items (i.e., statements) that constitute the scale (2).

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense	Funen

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Results of the Readiness and Enablement Index for Health Technology (READHY)	All participants will have a READHY-score calculated. Score ranges from 1-4. A higher score indicates a higher degree of health technology readiness.	1 month
Primary	Grouping using (Readiness and Enablement Index for Health Technology) READHY-scores	Using the results of the whole cohort, cluster analysis will be applied to group the participants into groups on levels of health technology readiness. Score ranges from 1-4. A higher score indicates a higher degree of health technology readiness.	6 months