Assessing the Dutch-language version of a questionnaire designed to assess the impact of the side effects of radiotherapy in patients with head and neck cancer
| ISRCTN | ISRCTN12923581 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12923581 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | B3002021000111 |
| Sponsor | Antwerp University Hospital |
| Funder | Universitair Ziekenhuis Antwerpen |
- Submission date
- 27/09/2021
- Registration date
- 20/11/2021
- Last edited
- 22/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
The aim of this study is to assess the Dutch-language version of a questionnaire designed to assess the impact of the side effects of radiotherapy in patients with head and neck cancer. The questionnaire examines quality of life related to dysphagia (swallowing difficulties) and explores the patient's view of his/her swallowing problem and the resulting limitations in activities and participation. This questionnaire was originally developed in English and has already been translated and validated in Chinese. A Dutch equivalent does not exist to date.
Who can participate?
Patients aged 18 years and over with head and neck cancer who were treated with (chemo)radiotherapy and/or surgery at least 6 months ago
What does the study involve?
All patients are asked to fill out three questionnaires. At the same time, a speech-language pathologist will interview the patient to assess their performance status and their speech, diet and ability to eat in public. Patients are given a second copy of the questionnaire to take home and are asked to fill it in again after 1 week.
What are the possible benefits and risks of participating?
There are no additional risks or benefits of participating in this study.
Where is the study run from?
Antwerp University Hospital (Belgium)
When is the study starting and how long is it expected to run for?
January 2021 to December 2021
Who is funding the study?
Antwerp University Hospital (Belgium)
Who is the main contact?
Prof. Dr. Gwen Van Nuffelen
Gwen.vannuffelen@uza.be
Contact information
Scientific
Wilrijkstraat 10
Edegem
2650
Belgium
 ORCID ID |
0000-0001-6934-4168 |
|---|---|
| Phone | +32 (0)38212013 |
| gwen.vannuffelen@uza.be |
Public
Wilrijkstraat 10
Edegem
2650
Belgium
| ORCID ID |
0000-0001-6934-4168 |
|---|---|
| Phone | +32 (0)38212013 |
| gwen.vannuffelen@uza.be |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Multicenter longitudinal study |
| Secondary study design | Longitudinal study |
| Study type | Participant information sheet |
| Scientific title | Validation and assessment of the psychometric characteristics of the Head and Neck Cancer Survivors’ Assessment of Mealtimes (D-HNSAM) |
| Study acronym | D-HNSAM |
| Study objectives | It is hypothesized that the Dutch version of the Head and Neck Cancer Survivors’ Assessment of Mealtimes (D-HNSAM), a patient-oriented questionnaire designed specifically for head and neck cancer (HNC) patients, is a valid, reliable and feasible instrument in patients treated with radiotherapy for HNC. The questionnaire is based on the ICF (International Classification of Functioning, Disability and Health) model and focuses on the psychosocial problems experienced by HNC patients with dysphagia. It examines dysphagia-related quality of life (QoL) and explores the patient's own view of his/her swallowing problems and the resulting limitations in activities and participation. |
| Ethics approval(s) | Approved 12/07/2021, Ethical Committee of the University of Antwerp (Prinsstraat 13, 2000 Antwerpen, Belgium; +32 (0)38213897; ethisch.comite@uza.be), ref: 2021-0264 - Edge 001685 |
| Health condition(s) or problem(s) studied | Patients with head and neck cancer treated with radiotherapy, surgery, chemoradiotherapy or a combination of the before mentioned treatment modalities |
| Intervention | This is a multicenter, longitudinal study with the aim of validating the Dutch version of the Head and Neck Cancer Survivors’ Assessment of Mealtimes (D-HNSAM). The D-HNSAM is first translated according to the cross-cultural adaptation process described in international guidelines. The D-HNSAM is filled in together with the Dysphagia Handicap Index (DHI) and the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P). The speech-language pathologist will complete the Performance Status Scale - Head and Neck Cancer (PSS-HN) and the Functional Oral Intake Scale (FOIS) based on a short interview with the patient. All instruments are administered at baseline and after 1 week, patients are asked to fill out the D-HNSAM again for test-retest reliability evaluation. This data is used to assess the validity and reliability of the D-HNSAM. This is a multicentre trial: the University Hospital of Anwerp and the University Hospital of Ghent are participating in this trial. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Dysphagia-related quality of life (QoL) and the patient's own view of his/her swallowing problems and the resulting limitations in activities and participation, assessed using the Dutch-Head and Neck Cancer Survivors’ Assessment of Mealtimes (D-HNSAM) (patient questionnaire) at baseline and after 1 week |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 20/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Patients with head and neck cancer treated with radiotherapy or chemoradiotherapy; tumor located in the oral cavity, oropharynx, nasopharynx, hypopharynx or larynx 2. Patients with head and neck cancer treated with surgery; tumor located in the oral cavity, oropharynx, nasopharynx, hypopharynx or larynx 3. The treatment was completed at least 6 months ago 4. Aged 18 years or older 5. Without any cognitive disorders |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 20/07/2021 |
| Date of final enrolment | 31/07/2021 |
Locations
Countries of recruitment
- Belgium
Study participating centres
Edegem
2650
Belgium
Ghent
9000
Belgium
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository |
| 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/). Patient information (no identifying information), surveys and measurements will be shared. The data will be available for all participating study investigators until the end of the study. All data will be anonymised, patient’s details will be encoded. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 23/10/2022 | 22/01/2024 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
22/01/2024: Publication reference added.
15/12/2022: The intention to publish date was changed from 31/12/2022 to 31/07/2023.
23/08/2022: The following changes were made to the trial record:
1. The overall end date was changed from 31/08/2022 to 20/12/2021.
2. The recruitment end date was changed from 31/07/2022 to 31/07/2021.
3. The total final enrolment was added.
4. The plain English summary was updated to reflect these changes.
05/10/2021: Trial's existence confirmed by the Ethical Committee of the University of Antwerp.
