Clinical trial NCT04745117: Health Technologies Readiness in Breast Cancer Patients
Official title: The Degree of Health Technologies Readiness Amongst Patients With Suspected Breast Cancer Using the READHY-tool
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Health Technology Readiness
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Results of the Readiness and Enablement Index for Health Technology (READHY)
timeFrame: 1 month
measure: Grouping using (Readiness and Enablement Index for Health Technology) READHY-scores
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
state: Funen
Study officials:
References: