Health Technologies Readiness in Breast Cancer Patients

NCT ID: NCT04745117

Last Updated: 2023-03-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2021-08-31

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Women with suspected breast cancer

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

READHY - questionnaire

Intervention Type: BEHAVIORAL

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).

Interventions

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).

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Martin Sollie

Medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Odense University Hospital

Odense, Funen, Denmark

Countries

Denmark

Other Identifiers

21/4657

Identifier Type: -

Identifier Source: org_study_id