Evaluation of Technology Acceptance and Electronic Health (Ehealth) Literacy of Patients Undergoing Radiotherapy (RO_eHEALTH)

August 27, 2025 updated by: Prof. Dr. Franziska Hausmann, Charite University, Berlin, Germany
Evaluation of technology acceptance and digital health literacy (eHealth literacy) of patients undergoing radiotherapy. In addition, a qualitative survey of data on the patient journey and its influence on overall satisfaction will be conducted

Study Overview

Status

Completed

Conditions

Detailed Description

Examining the acceptance, trust and communication of a novel patient interaction system in a user-centered manner is essential due to several critical factors highlighted in the literature. The integration of technology into healthcare significantly changes the roles and interactions between healthcare stakeholders, including patients, healthcare providers and the technology itself (Kim et al., 2024). As the use of artificial intelligence (AI) and other advanced technologies in clinical decision-making increases, it is crucial to understand how patients perceive and interact with these systems. Research by Kim et al. (2024) emphasizes that patients have different preferences regarding AI autonomy, so it is important to involve them in defining and regularly reassessing the scope of AI support to ensure it is both effective and acceptable (Kim et al., 2024).

Trust in technology is a key factor influencing its acceptance and effectiveness. Patient trust in AI and other digital health tools can be influenced by their experience, perceived reliability and transparency of the technology. Li (2024) discusses that trust is strengthened when the benefits and reliability of the technology are clearly demonstrated. For example, studies on digital twins in antenatal care show that the perceived reliability of AI predictions and personalized care plays an important role in building trust (Li, 2024). Addressing trustworthiness concerns through user-centered design can help build trust by ensuring that the technology is transparent, explainable, and aligned with patients' needs and values.

Effective communication between patients and healthcare providers is an essential prerequisite for shared decision-making, a core principle of patient-centered care. Hao et al. (2024) state that patient-centered shared decision-making improves healthcare outcomes and patient satisfaction by ensuring that patients are well informed and actively involved in their care decisions (Hao et al., 2024). The integration of technology must promote this communication and not hinder it. For example, patient-centered decision aids can improve the quality of decisions and patient satisfaction if they are designed to support shared decision making by providing clear, personalized information that patients can discuss with their healthcare providers (Hao et al., 2024).

Patient acceptance of the technology is also crucial for its successful introduction. Acceptance is influenced by factors such as ease of use, perceived benefits and the extent to which the technology fits into patients' existing routines and workflows. Research by Kambhamettu et al. (2024) suggests that explainability and meaningful engagement with the technology are key to promoting adoption. This aligns with the findings that by involving patients in the development process, potential barriers to acceptance can be identified and removed (Kambhamettu et al., 2024). By ensuring that the technology is intuitive and meets patients' needs, user-centered design practices can facilitate the seamless integration of technology into patients' healthcare.

In addition, Corti (2024) emphasizes the importance of continuous assessment and adjustment of patient-technology interactions to ensure alignment with patient expectations and preferences. This approach ensures that the technology remains relevant and effective over time (Corti, 2024).

The basis for any integration of digital solutions into patient care, for example the integration of ePROMs into patient care, is a high level of digital health literacy. As part of this study, the digital health literacy of patients undergoing radiotherapy will now be examined in a qualitative and quantitative study . In addition, factors influencing digital health literacy and technology acceptance that could prevent these patients from being integrated into digital health solutions will be identified.

Study Type

Interventional

Enrollment (Actual)

213

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Berlin, Germany, 13353
        • Charité University Medicine Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Indication for carrying out radiotherapy
  • Capacity to consent
  • At least 18 years of age
  • Sufficient knowledge of the German language

Exclusion Criteria:

  • Lack of capacity to consent
  • Age <18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Arm
All patients undergoing radiotherapy at the Clinic for Radiotherapy (Campus Virchow Klinikum, Campus Benjamin Franklin) will be informed about the possibility of participating in the study. If written consent is given, patients will be asked to complete the established questionnaires (EORTC QLQ-C30 and eHEALS) and a questionnaire to collect epidemiological data at their next visit to the respective clinics.
All patients undergoing radiotherapy at the Clinic for Radiotherapy (Campus Virchow Klinikum, Campus Benjamin Franklin) will be informed about the possibility of participating in the study (RO_eHEALTH I). If written consent is given, patients will be asked to complete the established questionnaires (EORTC QLQ-C30 and eHEALS) and a questionnaire to collect epidemiological data at their next visit to the respective clinics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
eHEALS
Time Frame: once during treatment
The eHEALS questionnaire consists of 16 questions, higher scores mean higher ehealth literacy, scores between 0 and 80
once during treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related Quality of Life
Time Frame: once during treatment
EORTC QLQ C30 Questionnaire, scores between 0 and 100, higher scores means better quality of life
once during treatment
Epidemiologic data
Time Frame: once during treatment
descriptive assessment of epidemilogic data concerning income, language skills, use of cell phone
once during treatment
Treatment characteristics
Time Frame: once during therapy
descriptive data on e.g. tumor type, treatment duration, outpatient or inpatient treatment
once during therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2024

Primary Completion (Actual)

July 15, 2025

Study Completion (Actual)

July 15, 2025

Study Registration Dates

First Submitted

October 15, 2024

First Submitted That Met QC Criteria

October 15, 2024

First Posted (Actual)

October 17, 2024

Study Record Updates

Last Update Posted (Estimated)

August 28, 2025

Last Update Submitted That Met QC Criteria

August 27, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • EA4/125/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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