Assessing Dutch-language versions of two questionnaires design to assess the impact of side effects of radiotherapy in patients with head and neck cancer

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)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN49549338

Enrollment

Registered

2020-10-05

Start date

2018-12-11

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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. T

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

Belgium

Contacts

Public ContactGwen Van Nuffelen

gwen.vannuffelen@uza.be+32 38212013

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026