Condition category
Cancer
Date applied
25/09/2020
Date assigned
05/10/2020
Last edited
02/10/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Radiotherapy uses radiation to kill cancer cells. Along with surgery, it is the most frequently used treatment for patients with head and neck cancer (HNC, cancer in the mouth, nose and throat). Unfortunately, radiotherapy in the head and neck area can also damage healthy tissues. This can reduce people's ability to carry out daily activities of life as they did before, which can then impact on their quality of life (QoL). The most common side effects during radiotherapy are radiation dermatitis (skin irritation and soreness), oral mucositis (mouth irritation and soreness), xerostomia (dry mouth), loss of taste, fatigue, dysphagia (swallowing problems) and dysphonia (problems with speaking).
Oral mucositis tends to be the problem that results in a reduction in radiotherapy dose or frequency. It results in pain, bleeding and infections, which can lead to problems with swallowing and reduction in food intake. Since this side effect has a significant impact on QoL, it is important to assess oral mucositis in patients with HNC during their treatment.
All of the radiation-associated side effects can severely affect patients and their social, family and work activities and relationships. They can even harm a person's self-esteem. This means it is also important to assess patients' abilities to perform daily life activities and their quality of life.
The aim of this study is to translate from English to Dutch two questionnaires that assess the impact of oral mucositis and the impact of HNC radiotherapy on the patient's ability to speak, diet and ability to eat in public and to assess their usefulness in measuring the impact on the patient.

Who can participate?
Adult HNC patients treated with radiotherapy with or without chemotherapy (drug treatment combined with radiotherapy)

What does the study involve?
All patients are asked to fill out three questionnaires before the start of radiotherapy and during weeks 3, 4 and 5 of radiotherapy. At the same times, a cancer radiotherapy specialist will assess their side effects and a speech specialist will interview the patient to assess their speech, diet and ability to eat in public.

What are the possible benefits and risks of participating?
There are no additional risks or benefits of participating in this study, since the patients will receive their cancer treatment as normal.

Where is the study run from?
Antwerp University Hospital (Belgium)

When is the study starting and how long is it expected to run for?
August 2018 to May 2020

Who is funding the study?
Kom Op Tegen Kanker (Belgium)

Who is the main contact?
Prof. Dr. Gwen Van Nuffelen
Gwen.vannuffelen@uza.be

Trial website

Contact information

Type

Scientific

Primary contact

Prof Gwen Van Nuffelen

ORCID ID

http://orcid.org/0000-0001-6934-4168

Contact details

Wilrijkstraat 10
Edegem
2650
Belgium
+32 38212013
gwen.vannuffelen@uza.be

Type

Public

Additional contact

Prof Gwen Van Nuffelen

ORCID ID

http://orcid.org/0000-0001-6934-4168

Contact details

Wilrijkstraat 10
Edegem
2650
Belgium
+32 38212013
gwen.vannuffelen@uza.be

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

B300201837097

Study information

Scientific title

The validation and psychometric properties of the Dutch version of the Oral Mucositis Weekly Questionnaire-Head and Neck Cancer (D-OMWQ-HN) and the Performance Status Scale-Head and Neck Cancer (D-PSS-HN)

Acronym

Study hypothesis

We hypothesize that the Dutch version of the Oral Mucositis Weekly Questionnaire (D-OMWQ-HN), a questionnaire designed to assess the symptoms of oral mucositis and their impact on patient function and well-being) and the Dutch version of the Performance Status Scale for Head and Neck Cancer (D-PSS-HN), a questionnaire designed to assess function (including understandability of speech, normalcy of diet and eating in public), are valid, reliable and feasible instruments in patients treated with radiotherapy for head and neck cancer.

Ethics approval

Approved 14/08/2018, Ethical Committee of the University of Antwerp (Prinsstraat 13, 2000 Antwerpen, Belgium; +32 38213000; ethisch.comite@uza.be), ref: 18/05/056

Study design

Multicenter longitudinal study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Patients treated with (adjuvant) radiotherapy for head and neck cancer

Intervention

This is a multicenter, longitudinal study with the aim of validating the Dutch version of the Oral Mucositis Weekly Questionnaire and the Performance Status Scale for Head and Neck Cancer patients.

The D-OMWQ-HN and D-PSS-HN are first translated according to the cross-cultural adaptation process described in international guidelines.

The D-OMWQ-HN is filled in together with the Functional Assessment of Cancer Therapy - Head & Neck cancer (FACT-HN) and the Dutch version of the dysphagia-related quality of life assessment tool D-SWAL-QOL. The RTOG/EORTC grading of radiation-inmduced morbidity is completed by the radiation oncologist. The Functional Oral Intake Scale (FOIS) and D-PSS-HN are completed by a speech and language pathologist based on a short interview with the patient. All instruments are administered at baseline and during week 3, 4 and 5 of radiotherapy treatment. This data is used to assess the validity and reliability of the D-OMWQ-HN and D-PSS-HN.

During week 4, the D-OMWQ-HN and D-PSS-HN are filled in twice within 24-48 h for test-retest reliability evaluation.

Data collected during week 5 is used to assess reliability and validity.

This is a multicentre trial: the University Hospital of Anwerp and the University Hospital of Ghent are participating in this trial.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. D-OMWQ-HN (Dutch Oral Mucositis Weekly Questionnaire Head and Neck Cancer): mucositis-specific questionnaire assessing patient well-being and function
Method of measurement: patient questionnaire
Timepoint: baseline, week 3, 4 (twice within 24-48 hours) and 5 of radiotherapy.
2. D-PSS-HN (Dutch Performance Status Scale Head and Neck Cancer): clinician-rated instrument consisting of three subscales addressing areas of diet, speech and eating in public
Method of measurement: patient interview
Timepoint: baseline, week 3, 4 (twice within 24-48 hours) and 5 of radiotherapy.
3. FACT-HN (Functional Assessment of Cancer Therapy Head and Neck Cancer): multidimensional quality of life instrument developed specifically for the oncologic population
Method of measurement: patient questionnaire
Timepoint: baseline, week 3, 4 and 5 of radiotherapy.
Measure: used to assess the discriminant validity of the D-PSS-HN and the D-OMWQ-HN and the convergent validity of the D-OMWQ-HN
4. SWAL-QOL (Swallowing Quality of Life Questionnaire): is a dysphagia-specific patient questionnaire evaluating domains of dysphagia related to quality of life: general burden, eating duration, eating desire, food selection, communication, fear of eating, social functioning, mental health, sleep and fatigue
Method of measurement: patient questionnaire
Timepoint: baseline, week 3, 4 and 5 of radiotherapy.
Measure: used to assess the convergent validity of the D-PSS-HN and the discriminant validity of the D-OMWQ-HN
5. RTOG/EORTC (the Toxicity criteria of the Radiation Therapy Oncology Group (RTOG)/European Organization for Research and Treatment of Cancer (EORTC)): the radiation oncologist determines the grade of oral mucositis by means of a clinical examination
Method of measurement: clinical examination
Timepoint: baseline, week 3, 4 and 5 of radiotherapy
Measure: used to assess the convergent validity of the D-OMWQ-HN
6. FOIS (Functional Oral Intake Scale): is a clinican-rated scale, used to assess the current status and changes in oral intake
Method of measurement: patient interview
Timepoint: baseline, week 3, 4 and 5 of radiotherapy
Measure: used to assess the convergent validity of the D-PSS-HN

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

03/08/2018

Overall trial end date

25/05/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients with head and neck cancer treated with radiotherapy or chemoradiotherapy
2. Tumor located in the oral cavity, oropharynx, nasopharynx, hypopharynx or larynx
3. Aged 18 years or older

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

75

Participant exclusion criteria

1. Patients treated with experimental medication used for oral mucositis
2. Cognitive problems

Recruitment start date

11/12/2018

Recruitment end date

27/04/2020

Locations

Countries of recruitment

Belgium

Trial participating centre

Univeristy Hospital of Antwerp
Wilrijkstraat 10
Edegem
2650
Belgium

Trial participating centre

University Hospital of Ghent
Corneel Heymanslaan 10
Gent
900
Belgium

Sponsor information

Organisation

Antwerp University Hospital

Sponsor details

Wilrijkstraat 10
Edegem
2650
Belgium
+32 38212013
ctc@uza.be

Sponsor type

Hospital/treatment centre

Website

http://www.uza.be/english

Funders

Funder type

Charity

Funder name

Kom Op Tegen Kanker

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
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.

Intention to publish date

31/12/2020

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

02/10/2020: Trial’s existence confirmed by Ethical Committee of the University of Antwerp.