Primary objective:To investigate in Adolescent and Young Adult (AYA) Head and Neck Cancer (HNC) survivors treated with unilateral radiotherapy 5-10 years before, the long-term vascular complications in terms of carotid wall changes (ultrasonography…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Miscellaneous and site unspecified neoplasms benign
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Vascular complications:
a. Intima Media thickness on ultrasonography in the irradiated versus the
non-irradiated artery
b. Carotid wall elastography on ultrasonography in the irradiated versus the
non-irradiated artery
c. Carotid wall thickness on MRI in the irradiated versus the non-irradiated
artery
d. Radiological characteristics of carotid wall changes on MRI of the
irradiated versus the non-irradiated artery
e. Cerebral infarctions and white matter lesions on MRI
f. Cardiovascular risk profile 5-10 years after radiotherapy because of HNC
Secondary outcome
2. Psychosocial complications:
a. Cognitive function 5-10 years after RT in HNC patients
b. Frequency of memory complaints, anxciety, depression, fatique
c. Employment ability
Background summary
With increasing numbers of cancer survivors, strategies to prevent long-term
complications in cancer patients become more important. Adolescent and Young
Adult (AYA) Head and Neck Cancer (HNC) survivors are prone to long-term
complications, especially vascular and psychosocial complications. Although
several studies point to the importance of these long-term complications,
structured survivorship care for AYA HNC survivors is still lacking.
Study objective
Primary objective:
To investigate in Adolescent and Young Adult (AYA) Head and Neck Cancer (HNC)
survivors treated with unilateral radiotherapy 5-10 years before, the long-term
vascular complications in terms of carotid wall changes (ultrasonography, MRI),
cerebral vascular complications ((silent)brain infarctions, white matter
lesions) and Cardiovascular Risk profile.
Secondary objective:
To investigate in Adolescent and Young Adult (AYA) Head and Neck Cancer (HNC)
survivors treated with unilateral radiotherapy 5-10 years before, the long-term
psychosocial complications (subjective memory complaints, anxiety, depression,
fatigue, experience of positive health, working disabilities, objective memory
complaints).
Study design
Cross sectional cohort study.
Intervention
Structured survivorship care * 5 years after radiotherapy conform the
Personalized Cancer Survivorship Care Model of the Radboudumc Expertisecenter
of late effects after cancer, extended with carotid ultrasonography (IMT and
elastography), MRI of the carotid arteries and brain), neuropsychological
assessment battery and self-reported questionnaires concerning depression,
fatigue, QoL, positive health and employment status.
Study burden and risks
The estimated time window per patiënt is:
Questionnaires: 60 minutes
MRI: 30-60 minutes
Ultrasonography: 30 minutes
Neuro Psychological Examination: 60 minutes
The appointments will be planned at the same day as the regular appointment in
the hospital.
Geert Grooteplein zuid 8
Nijmegen 6500 HB
NL
Geert Grooteplein zuid 8
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
- Patients treated with unilateral radiotherapy of the neck at adolescent or
young adult age (18-40 year) 5-10 years before.
- Competent to make own discicions
- *18 years of age
Exclusion criteria
- Contra indication MRI
- Not able to understand the Dutch language
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL71550.091.19 |