Clinical practices in head and neck cancer: the role of the speech and language pathologist in assessment and management of swallowing disorders in patients treated with radiotherapy in Flanders
| ISRCTN | ISRCTN47855281 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47855281 |
| Secondary identifying numbers | ONZ-2022-0005 |
- Submission date
- 27/07/2022
- Registration date
- 06/10/2023
- Last edited
- 28/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Fifty to 60% of the patients who are treated with radiotherapy (RT) or (chemo)radiotherapy (CRT) for head and neck cancer (HNC) develop swallowing disorders. Swallowing disorders can occur as an acute side effect during treatment, but can also persist for months to years after RT treatment. Literature shows that quality of life (QoL) in HNC patients treated with CRT improves significantly when patients are referred to a speech language pathologist (SLP) for education and assessment prior to treatment. Furthermore, several studies already demonstrated the positive effects of preventative strengthening exercises for the swallowing musculature, on muscle condition and swallowing function.
However, to the researchers' knowledge, there is no gold standard in Flanders for the assessment, counseling or (preventive) treatment of swallowing disorders in HNC patients and no data are available on the effective implementation of these aspects or on the role of the SLP within the HNC team. Therefore, the aim of this study is to assess the accessibility and provision of swallowing assessment, counseling and treatment by an SLP, before, during and after CRT for HNC patients in Flanders by means of an online survey.
Who can participate?
Radiation oncologists treating HNC patients in 11 radiotherapy centers in Flanders
What does the study involve?
This survey is sent out via a web-based application in May 2022 and a reminder to complete the questionnaire is sent out after 3 and 5 weeks.
What are the possible benefits and risks of participating?
There are no known risks with participation. The possible benefit is increased insight into dysphagia management in head and neck cancer patients in Flanders.
Where is the study run from?
Antwerp University Hospital (Belgium)
When is the study starting and how long is it expected to run for?
February 2022 to July 2022
Who is funding the study?
Kom op tegen Kanker (Belgium)
Who is the main contact?
1. Prof. Dr Fréderic Duprez, frederic.duprez@uzgent.be
2. Margot Baudelet, margot.baudelet@Ugent.be
Contact information
Principal Investigator
University Hospital Ghent
Corneel Heymanslaan 10
Ghent
9000
Belgium
| Phone | +32 (0)3 821 30 00 |
|---|---|
| frederic.duprez@uzgent.be |
Scientific
University Hospital Ghent
Corneel Heymanslaan 10
Ghent
9000
Belgium
 ORCID ID |
0000-0003-0431-5854 |
|---|---|
| Phone | +32 (0)93320872 |
| margot.baudelet@Ugent.be |
Study information
| Study design | Prospective observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Prospective observational study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Clinical practices in head and neck cancer: the role of the speech and language pathologist in assessment and management of dysphagia in patients treated with radiotherapy in Flanders |
| Study objectives | Literature indicates that, despite increased attention, accessibility to early dysphagia management in head and neck cancer (HNC) patients often remains a problem. Although an increasing number of studies point to the fact that a speech language pathologist (SLP) plays an important role in the multidisciplinary team of HNC patients, there is no gold standard in Flanders for the assessment, counseling or (preventive) treatment of dysphagia in HNC patients. Consequently, to the researchers' knowledge, no data are available on the effective implementation of these aspects or on the role of the SLP within the HNC team. Therefore, the aim of this study is to assess the accessibility and provision of swallowing/dysphagia assessment, counseling and treatment by an SLP, before, during and after (chemo)radiotherapy (CRT) for HNC patients in Flanders by means of an online survey. |
| Ethics approval(s) | Approved 18/02/2022, University Hospital Ghent Ethics Committee (C. Heymanslaan 10, 9000 Ghent, Belgium; +32 (0)9 332 33 36; ethisch.comite@uzgent.be), ref: ONZ-2022-0005 |
| Health condition(s) or problem(s) studied | Dysphagia management in head and neck cancer patients treated with radiotherapy in Flanders |
| Intervention | The aim of this survey study is to assess the accessibility and provision of swallowing/dysphagia assessment, counseling and treatment by an SLP, before, during and after CRT for HNC patients in Flanders by means of an online survey. This online survey is sent to all RT centers in Flanders treating HNC patients via REDCap (Research Electronic Data Capture) electronic data capture tools hosted at Ghent University Hospital). |
| Intervention type | Behavioural |
| Primary outcome measure | Availability of dysphagia management and the role of the SLP in HNC patients, measured by means of a web-based survey sent to radiation oncologists in Flanders at a single timepoint |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 07/02/2022 |
| Completion date | 31/07/2022 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 11 |
| Total final enrolment | 10 |
| Key inclusion criteria | 1. Radiation oncologists 2. Working in Flemish hospitals with a radiotherapy department 3. Responsible for the treatment of HNC patients |
| Key exclusion criteria | Does not meet the inclusion criteria |
| Date of first enrolment | 20/05/2022 |
| Date of final enrolment | 20/06/2022 |
Locations
Countries of recruitment
- Belgium
Study participating centre
Ghent
9000
Belgium
Sponsor information
Hospital/treatment centre
Corneel Heymanslaan 10
Ghent
9000
Belgium
| Phone | +32 (0)3 821 30 00 |
|---|---|
| info@uzgent.be | |
| Website | https://www.uza.be |
"ROR" |
https://ror.org/00xmkp704 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Fight Cancer
- Location
- Belgium
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. All data will be stored in REDCap, a secure web application for building and managing online surveys and databases (https://www.project-redcap.org/). The data will be available for all participating study investigators until the end of the study. All data will be anonymised and participant details will be encoded. |
Editorial Notes
28/08/2024: The intention to publish date was changed from 31/12/2022 to 31/12/2025.
29/07/2022: Trial's existence confirmed by the University Hospital Ghent Ethics Committee.
