Retinoblastoma Clinical Trial
— RbNeuroQoLOfficial title:
Cognitive Functioning and Health Related Quality of Life in Retinoblastoma Survivors (8-35 Years): The Role of Cancer Treatment and Repeated Anesthesia
Verified date | January 2024 |
Source | Amsterdam UMC, location VUmc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
A retrospective crosssectional observational study of the effects of oncological treatment and frequent general anesthesia on neuropsychological development, psychosocial functioning (in terms of anxiety, depression, peer relations, perceived cognitive functioning and potential trauma) and health related quality of life in children and young adults who were treated or screened for retinoblastoma.
Status | Enrolling by invitation |
Enrollment | 660 |
Est. completion date | March 31, 2028 |
Est. primary completion date | March 31, 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 35 Years |
Eligibility | Inclusion Criteria Rb survivors and Rb risk carriers (age 8-35 years): - Rb diagnosis, (main) treatment and follow-up of Rb patients and -survivors, or Rb screening took place at the Dutch Retinoblastoma Expertise Center of the Amsterdam University Medical Center, - Rb survivor or former Rb risk carriers is between 8 and 35 years old, - Average understanding of the Dutch language. Inclusion Criteria parents of Rb patients, Rb survivors or Rb risk carriers (6 months - 12 years): - Being a caregiver of a Rb survivor or Rb risk carrier that have been diagnosed and receive(d) (main) treatment and follow-up or screening at the Dutch Retinoblastoma Expertise Center of the Amsterdam University Medical Center, - The related Rb survivor or Rb risk carrier is < 12 years old, - Average understanding of the Dutch language. Exclusion Criteria: - Pre-existing documented developmental delay and/or severe cognitive impairments (IQ <70), - Having an active, uncontrolled psychiatric illness, - Rb diagnostic trajectory, treatment and follow-up at another hospital or before the founding of the Dutch Retinoblastoma Expertise Center in 1991. With exception of Rb survivors (diagnosed >1991) who apart from treatment at the Dutch Retinoblastoma Center also required specialized treatment (such as radiation) at another center: they are illegible for inclusion. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Amsterdam University Medical Center | Amsterdam | Noord-Holland |
Lead Sponsor | Collaborator |
---|---|
Amsterdam University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall functioning in Rb | General cognitive functioning, psychosocial functioning and health related Quality of life in Rb survivors and Rb risk carriers | Through study completion, an average of 3 years | |
Primary | Effects of oncological treatment and frequent anesthesia | Effects of biological and physiological factors on cognitive functioning, psychosocial functioning and health related quality of life in Rb survivors and Rb risk carriers | Through study completion, an average of 3 years | |
Primary | Parental functioning | To assess psychosocial functioning and HRQoL in parents of Rb patients, Rb survivors and Rb risk carriers (0-12 years old). | at least 6 months after diagnosis | |
Secondary | Neurocognitive profiles | Mapping neuropsychological profiles in Rb survivors and Rb risk carriers (8-35 years) | Through study completion, an average of 3 years | |
Secondary | Psychosocial functioning | Mapping overall psychosocial functioning in Rb survivors, Rb risk carriers (8-35 years and parents) | Through study completion, an average of 3 years |
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