Health Technologies Readiness in Breast Cancer Patients

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

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: READHY - questionnaire

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Denmark
  • Funen
    • Odense, Funen, Denmark, 5000
      • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All women referred to the Breast Cancer Center at Odense University Hospital under the suspicion of breast cancer.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Women with suspected breast cancer; All women referred under the diagnosis "suspected breast cancer" will be asked to fill out the questionnaire "READHY".

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Odense University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 9, 2021

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Health Technology Readiness
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 21/4657

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No