Cancer, BreastNCT06152419
Patient Education Videos to Improve Patients' Experience During Radiotherapy Treatment: a National Project
A study testing Questionnaire in people with Cancer, Breast and Cancer, Lung, run by University Hospital, Ghent at 1 site in Belgium.
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 This information is in many cases incorrect, outdated or not applying to the patient's situation.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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Breast, Cancer, Lung, Cancer Prostate
- What is being tested?
- Questionnaire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Oct 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of cancer,
- age ≥ 18 years,
- undergoing radiotherapy as part of their treatment
Who cannot join
- history of previous radiation treatment
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Universitary Hospital
Ghent, Oost-Vlaanderen, 9000
Liv Veldeman, prof. dr., 09 332 30 15, liv.veldeman@uzgent.be
Renée De Noyette, 0470209936, Renee.DeNoyette@UGent.be
About this study
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 This information is in many cases incorrect, outdated or not applying to the patient's situation.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.
Read the 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.
- Being tested
- Questionnaire
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Prostatic Neoplasms, Head and Neck Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Trough study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start17 Oct 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, BreastStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Stichting tegen Kanker
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152419
- Sponsor's protocol ID
- ONZ-2022-0579
- Status last verified
- Jan 2024
- First submitted
- 6 Nov 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Education Videos to Improve Patients' Experience During Radiotherapy Treatment: a National Project
- ClinicalTrials.gov ID
- NCT06152419
- Acronym / sponsor ID
- ONZ-2022-0579
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Stichting tegen Kanker
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Interrogated patients | Experimental | Device: QuestionnairePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of cancer,
- age ≥ 18 years,
- undergoing radiotherapy as part of their treatment
Key exclusion criteria (1 listed)
- history of previous radiation treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairePatients will be asked to complete questionnaires to evaluate the quality and the impact of the video and to assess the need for additional information. | Device | Interrogated patients |
Primary outcome
Questionaire to increase knowledge of radiotherapy
Time frame: 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
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire in people with Cancer, Breast and Cancer, Lung, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liv Veldeman, prof. dr. (09 332 30 15, liv.veldeman@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionaire to increase knowledge of radiotherapy (time frame: Trough study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.