Patient Education Videos to Improve Patients' Experience During Radiotherapy Treatment: a National Project

Sponsor

University Hospital, Ghent (Other)

Overall Status

Recruiting

CT.gov ID

NCT06152419

Collaborator

Stichting tegen Kanker (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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 This information is in many cases incorrect, outdated or not applying to the patient's situation.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.

Condition or Disease	Intervention/Treatment	Phase
Cancer, Breast Cancer, Lung Cancer Prostate Cancer Head Neck Cancer, Gastrointestinal	Device: Questionnaire	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

A first video illustrating the general radiotherapy process was created with voice-over in Dutch and French. The video will be shown to 125 patients undergoing radiotherapy in 3 Flemish and 2 Walloon radiotherapy departments. 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. Patients will be recruited at the first consultation at the radiotherapy department or at one of the first radiotherapy sessions. In addition, focus groups will be organised to assess whether this video meets the patients' needs. At least 25 patients at at UZ Gent will be invited to participate in 5 focus groups, each focus group concentrating on one of the 5 most frequent tumor groups. Based on the collected data, both a qualitative and quantitative. In a second phase, additional visual material will be created.A first video illustrating the general radiotherapy process was created with voice-over in Dutch and French. The video will be shown to 125 patients undergoing radiotherapy in 3 Flemish and 2 Walloon radiotherapy departments. 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. Patients will be recruited at the first consultation at the radiotherapy department or at one of the first radiotherapy sessions. In addition, focus groups will be organised to assess whether this video meets the patients' needs. At least 25 patients at at UZ Gent will be invited to participate in 5 focus groups, each focus group concentrating on one of the 5 most frequent tumor groups. Based on the collected data, both a qualitative and quantitative. In a second phase, additional visual material will be created.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Patient Education Videos to Improve Patients' Experience During Radiotherapy Treatment: a National Project

Actual Study Start Date :

Oct 17, 2023

Anticipated Primary Completion Date :

Dec 17, 2023

Anticipated Study Completion Date :

Jul 17, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Interrogated patients 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. Patients will be recruited at the first consultation at the radiotherapy department or at one of the first radiotherapy sessions. In addition, focus groups will be organised to assess whether this video meets the patients' needs.	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.

Arm

Intervention/Treatment

Experimental: Interrogated patients

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. Patients will be recruited at the first consultation at the radiotherapy department or at one of the first radiotherapy sessions. In addition, focus groups will be organised to assess whether this video meets the patients' needs.

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.

Outcome Measures

Primary Outcome Measures

Questionaire to increase knowledge of radiotherapy [Trough study completion, an average of 1 year]
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).
Patient questionnaire on radiotherapy-related anxiety [Trough study completion, an average of 1 year]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

diagnosis of cancer,
age ≥ 18 years,
undergoing radiotherapy as part of their treatment

Exclusion Criteria:

history of previous radiation treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitary Hospital	Ghent	Oost-Vlaanderen	Belgium	9000

Sponsors and Collaborators

University Hospital, Ghent
Stichting tegen Kanker

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Ghent

ClinicalTrials.gov Identifier:

NCT06152419

Other Study ID Numbers:

ONZ-2022-0579

First Posted:

Nov 30, 2023

Last Update Posted:

Nov 30, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Breast Neoplasms

Lung Neoplasms

Head and Neck Neoplasms

Gastrointestinal Neoplasms

Study Results

No Results Posted as of Nov 30, 2023