NCT06152419

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 This information is in many cases incorrect, outdated or not applying to the patient's situation.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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 17, 2023

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 30, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

1.2 years

First QC Date

November 6, 2023

Last Update Submit

January 3, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

Interrogated patients

EXPERIMENTAL

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

Interventions

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.

Interrogated patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- history of previous radiation treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitary Hospital

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsLung NeoplasmsProstatic NeoplasmsHead and Neck NeoplasmsGastrointestinal Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Liv Veldeman, prof. dr.

CONTACT

Renée De Noyette

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2023

First Posted

November 30, 2023

Study Start

October 17, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

January 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

The data of the questionnaires will be prospectively collected in the intelligent software database REDCap. Data collected include patient, tumour, diagnostic and treatment characteristics, and evaluation of the videos. The data is analyzed with statistical software.The group debate will be recorded. The recording will be destroyed after analysis of the data. The debate will be qualitatively processed with specific software, namely NVIVO.

Locations