Cognitive Functioning And Health Related Quality Of Life In Retinoblastoma Survivors: The Role Of Cancer Treatment And Repeated Anesthesia

Recruiting

• Conditions: gezondheidsgerelateerde kwaliteit van leven; Eye cancer; retinoblastoma; 10030054; 10009841

• Registration Number: NL-OMON53703
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 660

Inclusion Criteria

Cognitive functioning, psychosocial functioning and HRQoL in Rb survivors and
former Rb risk carriers (neuropsychological assessment and questionnaires):
In order to be eligible for inclusion the potential participant must meet all
inclusion criteria:
1. 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 Centers,
2. Rb survivor or former Rb risk carriers is between 8 and 35 years old,
3. Average understanding of the Dutch language.

Psychosocial wellbeing of the caregiver and pediatric trauma (only
questionnaires):
In order to be eligible for inclusion the potential participant must meet all
inclusion criteria:
1. 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
Centers,
2. The related Rb survivor or Rb risk carrier is < 12 years old,
3. Average understanding of the Dutch language.

Exclusion Criteria

A potential participant who meets any of the following criteria will be
excluded from participation in this study:
1. Pre-existing documented developmental delay and/or severe cognitive
impairments (IQ <70),
2. Having an active, uncontrolled psychiatric illness,
3. Rb diagnostic trajectory, treatment and follow-up at another hospital or
before the founding of the Dutch Retinoblastoom 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.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. To assess cognitive functioning (C1), psychosocial functioning (C2 ) and<br /><br>HRQoL (C3) in Rb survivors and Rb risk carriers<br /><br>2. To investigate the effects of biological and physiological factors on<br /><br>cognitive functioning, psychosocial functioning and HRQoL in Rb survivors and<br /><br>Rb risk carriers.<br /><br>3. To assess psychosocial functioning (C2) and HRQoL (C3) in parents (child<br /><br>0-12 years old).<br /><br>4. To study associations between outcomes (C0, C1, C2 and C3) in Rb survivors<br /><br>and Rb risk carriers, and their parents. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. To map neuropsychological profiles in Rb survivors and Rb risk carriers<br /><br>(8-35 years)(within C1).<br /><br>2. To map symptoms of psychosocial functioning in Rb survivors, Rb risk<br /><br>carriers (8-35 years and parents)(within C2).</p><br>