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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06152419
Other study ID # ONZ-2022-0579
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 17, 2023
Est. completion date December 31, 2024

Study information

Verified date January 2024
Source University Hospital, Ghent
Contact Liv Veldeman, prof. dr.
Phone 09 332 30 15
Email liv.veldeman@uzgent.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients often base their information on the experiences of other patients or on information they find on the internet. This information is in many cases incorrect, outdated or not applying to the patient's situation. This leads to misconceptions or inappropriate anxiety. During the intake consultation at the radiotherapy department, doctors, nurses and RTTs provide accurate and patient-specific information, but it can be overwhelming and it is known that only part of this information is remembered. Moreover, it remains difficult for a patient to imagine how the treatment will proceed. The combination of verbal information, supplemented with video material, seems to be the ideal way to convey information. After all, a video can be viewed again afterwards, possibly together with loved ones, or can be shown in advance in preparation of the consultation. In Belgium, the existence of patient education videos about radiotherapy is very limited. Making these kinds of videos is expensive and time consuming. For that reason, BeSTRO (Belgian Society for Radiotherapy and Oncology) started a project to make videos for patients that can be used nationally by all radiotherapy centers. The project is sponsored by Foundation against Cancer.


Description:

A first video illustrating the general radiotherapy process is already available. This video will be used as a 'test video' to be shown to patients undergoing radiotherapy in one of the 4 participating centers. Questionnaires will evaluate the quality and the impact of the video and will assess the need for additional information. Moreover, 25 patients will be invited to participate in 5 focus groups, each focus group concentrating on one of the 5 most frequent tumor groups (breast tumors, lung tumors, head and neck tumors, urological tumors and gastro-intestinal tumors). The information gathered from the questionnaires and focus groups will be used to determine the content and format of the next videos. In total, about 10 videos on specific parts of the radiotherapy process will be produced.


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - diagnosis of cancer, - age = 18 years, - undergoing radiotherapy as part of their treatment Exclusion Criteria: - history of previous radiation treatment

Study Design


Intervention

Device:
Questionnaire
Patients will be asked to complete questionnaires to evaluate the quality and the impact of the video and to assess the need for additional information.

Locations

Country Name City State
Belgium Universitary Hospital Ghent Oost-Vlaanderen

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Ghent Stichting tegen Kanker

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Questionaire to increase knowledge of radiotherapy We will evaluate the patients' knowledge about radiotherapy using a questionnaire and various focus groups.The outcome measurement will be the personal opinion of the patient about his/her knowledge about radiotherapy (I feel more educated - the video has no value). Trough study completion, an average of 1 year
Primary Patient questionnaire on radiotherapy-related anxiety We will evaluate the patients' treatment-related-anxiety by providing additional information (by means of an educational video). The outcome measurement will be the personal opinion of the patient about his/her anxiety (less fear - equal fear - more fear). Trough study completion, an average of 1 year
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