Clinical trial NCT06227962: Cognitive Functioning and Health Related Quality of Life in Retinoblastoma Survivors
Official title: Cognitive Functioning and Health Related Quality of Life in Retinoblastoma Survivors (8-35 Years): The Role of Cancer Treatment and Repeated Anesthesia
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Retinoblastoma
Neurocognitive Dysfunction
Health-Related Behavior
Keywords: Retinoblastoma
Cognition
Psychosocial functioning
HRQoL
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 660
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 350 Rb survivors and 310 Rb risk carriers (\<35 years) that have been treated or screened at the Dutch Retinoblastoma Expertise Center of the Amsterdam University Medical Center

Brief summary: 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.

Detailed description: Retinoblastoma (Rb) is the most common form of ocular cancer in children, with high survival rates in developed countries (\>90%). Rb can develop unilateral (one eye affected, sometimes hereditary), or bilateral (both eyes, always hereditary). Children are usually diagnosed at a young age (\<5 years) and are subjected to an intensive treatment and follow-up protocol immediately after. If Rb is diagnosed in early disease stages, eye-saving treatment could be provided, such as laser, cryo-, chemotherapy and/or radiotherapy -or a combination of these. When discovered in a later disease stage, enucleation (removing the eye) is often inevitable. Brothers and sisters or offspring of heredity Rb survivors that are at risk to develop Rb themselves (so called 'Rb risk carriers') will be screened according to the Dutch Rb Screening Protocol. The medical treatment and follow-up of Rb patients and screening of Rb risk carriers takes place under general anesthesia (GA) up to four or five years of age. At this age the brain is still developing and therefore extra vulnerable to iatrogenic damage, including neuropsychological complications. Immediate effects of the oncological treatment, as well as secondary effects due to multiple GA on cognitive development in Rb survivors is still understudied. Rb survivors report disease-related limitations in daily life and lower health related quality of life (HRQoL), which might be related to impaired cognitive functioning. Apart from possible immediate or secondary treatment effects, children with Rb are known to be experiencing psychosocial struggles, including anxiety and depression, declined participation and/or pediatric trauma, which may negatively affect HRQoL as well. Despite the impact on general wellbeing and HRQoL, the cognitive and emotional aspects of Rb are largely under addressed in pediatric care. It is important to gain insight in the cognitive development and psychosocial functioning from childhood into young adulthood of Rb survivors, as well psychosocial functioning of the parents in order to provide timely interventions, minimizing possible long-term consequences. It is hypothesized that extensive treatment and multiple GA is negatively associated with cognitive functioning, psychosocial functioning and HRQoL in Rb survivors and Rb risk carriers. Moreover, that psychological struggles and/or trauma strengthen these associations.

Eligibility criteria: 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.

Primary outcomes:
measure: Estimated intellectual functioning (Neurocognition)
timeFrame: This concerns a cross-sectional study meaning that a neuropsychological assessment is carried out only once on all participants during the course of the study until study completion, approximately in 2027.
measure: Processing speed (Neurocognition)
timeFrame: This concerns a cross-sectional study and data will be collected until April 2027. The neuropsychological assessment is carried out only once on all participants during the course of the study until study completion.
measure: Memory (Neurocognition)
timeFrame: This concerns a cross-sectional study and data will be collected until April 2027. The neuropsychological assessment is carried out only once on all participants during the course of the study until study completion.
measure: Verbal fluency (Neurocognition)
timeFrame: This concerns a cross-sectional study and data will be collected until April 2027. The neuropsychological assessment is carried out only once on all participants during the course of the study until study completion.
measure: Visual Motor Integration (Neurocognition)
timeFrame: This concerns a cross-sectional study and data will be collected until April 2027. The neuropsychological assessment is carried out only once on all participants during the course of the study until study completion.
measure: Sustained Auditory Attention (Neurocognition)
timeFrame: This concerns a cross-sectional study and data will be collected until April 2027. The neuropsychological assessment is carried out only once on all participants during the course of the study until study completion.
measure: Executive functioning (Neurocognition)
timeFrame: This concerns a cross-sectional study and data will be collected until April 2027. The neuropsychological assessment is carried out only once on all participants during the course of the study until study completion
measure: Anxiety (Psychosocial functioning)
timeFrame: This concerns a cross-sectional study. Digital questionnaires will be assessed (if applicable) within two weeks of the neuropsychological assessment, only once on all participants during the course of the study until study completion (expected 2027).
measure: Depression
timeFrame: This concerns a cross-sectional study. Digital questionnaires will be assessed (if applicable) within two weeks of the neuropsychological assessment, only once on all participants during the course of the study until study completion (expected 2027).
measure: Peer interaction (Psychosocial functioning))
timeFrame: This concerns a cross-sectional study. Digital questionnaires will be assessed (if applicable) within two weeks of the neuropsychological assessment, only once on all participants during the course of the study until study completion (expected 2027).
measure: Perceived neurocognitive functioning (Psychosocial functioning)
timeFrame: This concerns a cross-sectional study. Digital questionnaires will be assessed (if applicable) within two weeks of the neuropsychological assessment, only once on all participants during the course of the study until study completion (expected 2027).
measure: Participation and Activity (Psychosocial functioning)
timeFrame: This concerns a cross-sectional study. Digital questionnaires will be assessed (if applicable) within two weeks of the neuropsychological assessment, only once on all participants during the course of the study until study completion (expected 2027).
measure: Trauma (psychosocial functioning)
timeFrame: This concerns a cross-sectional study. Digital questionnaires will be assessed (if applicable) within two weeks of the neuropsychological assessment, only once on all participants during the course of the study until study completion (expected 2027).
measure: Health related quality of life (Psychosocial functioning)
timeFrame: This concerns a cross-sectional study. Digital questionnaires will be assessed (if applicable) within two weeks of the neuropsychological assessment, only once on all participants during the course of the study until study completion (expected 2027).
measure: Study specific outcomes
timeFrame: This concerns a cross-sectional study. Digital questionnaires will be assessed (if applicable) within two weeks of the neuropsychological assessment, only once on all participants during the course of the study until study completion (expected 2027).
Secondary outcomes:
measure: Parental anxiety
timeFrame: This concerns a cross-sectional study. The digital questionnaires will be assessed only once on all parents of participants (age 0-12) during the course of the study until study completion, expected in 2027.
measure: Parental depression
timeFrame: This concerns a cross-sectional study. The digital questionnaires will be assessed only once on all parents of participants (age 0-12) during the course of the study until study completion, expected in 2027.
measure: Parental symptoms of distress
timeFrame: This concerns a cross-sectional study. The digital questionnaires will be assessed only once on all parents of participants (age 0-12) during the course of the study until study completion, expected in 2027.
measure: Parental trauma
timeFrame: This concerns a cross-sectional study. The digital questionnaires will be assessed only once on all parents of participants (age 0-12) during the course of the study until study completion, expected in 2027.
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center
state: Noord-Holland
Study officials:
affiliation: Amsterdam University Medical Center
name: Annette C. Moll, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: