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

Validation and assessment of the psychometric characteristics of the Head and Neck Cancer Survivors’ Assessment of Mealtimes (D-HNSAM)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN12923581

Enrollment

Registered

2021-11-20

Start date

2021-07-20

Completion date

Unknown

Last updated

2024-02-05

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

Conditions

Patients with head and neck cancer treated with radiotherapy, surgery, chemoradiotherapy or a combination of the before mentioned treatment modalities Cancer

Interventions

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 accordi

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

Measure	Time frame
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 2. Swallowing-related quality of life assessed using the Dysphagia Handicap Index (DHI) (patient questionnaire) at baseline 3. Objective and subjective rehabilitation participation assessed using the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (patient questionnaire) at baseline 4. Normality of diet, eating in public, and speech intelligibility assessed using the Performance Status Scale - Head and Neck Cancer (PSS-HN) (clinician-based interview) at baseline 5. Oral intake capabilities assessed using the Functional Oral Intake Scale (FOIS) (clinician-based interview) at baseline	—

Measure

Time frame

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 2. Swallowing-related quality of life assessed using the Dysphagia Handicap Index (DHI) (patient questionnaire) at baseline 3. Objective and subjective rehabilitation participation assessed using the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (patient questionnaire) at baseline 4. Normality of diet, eating in public, and speech intelligibility assessed using the Performance Status Scale - Head and Neck Cancer (PSS-HN) (clinician-based interview) at baseline 5. Oral intake capabilities assessed using the Functional Oral Intake Scale (FOIS) (clinician-based interview) at baseline

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

Belgium

Contacts

Public ContactGwen Van Nuffelen

gwen.vannuffelen@uza.be+32 (0)38212013

Outcome results

None listed

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