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Nervous System Neoplasms

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Newly diagnosed brain tumour patients aged between 5 and 13 years

Patients diagnosed with Cystic Fibrosis aged between 5 and 13 years

Healthy children aged between 5 and 13 years

A Kingma, PhD

There is ample evidence that children treated for a brain tumour (BT) often develop deficits in social and emotional functioning. The investigators wish to examine the cause of these deficits, i.e. the underlying neuropsychological deficit(s). The aim is to study impairment and developmental delay in social cognition (and related cognitive functions) caused by brain damage in patients treated for a BT in childhood as compared to a reference group of chronically ill children. If we can identify the specific deficits these patients experience, neuropsychological treatment and guidance can be developed to give patients the most optimal chances to live as normal as possible, to improve their quality of life (QoL) and to prevent them from developing depression and anxiety. Eventually, an intervention programme could be developed based on our results, to improve social, vocational and emotional QoL.

* Rationale: There is ample evidence that children treated for a brain tumour (BT) often develop deficits in social and emotional functioning. The investigators wish to examine the cause of these deficits, i.e. the underlying neuropsychological deficit(s). The following is expected:

  1. Children treated for a BT will perform worse than both healthy controls and patients with Cystic Fibrosis (CF) on measures of social cognition at Time 2 (3 years post diagnosis), but not at Time 1 (shortly after diagnosis, before neurotoxic treatment). The deterioration in performance will be influenced by the following adverse factors:

     1. History of cranial radiation therapy;
     2. Site of lesion in diencephalon;
     3. History of hydrocephalus and/or posterior fossa syndrome;
     4. Younger age at diagnosis.
  2. Parents and teachers will rate patients with a BT as being less socially competent and experiencing more internalizing problems than healthy controls and patients with CF at Time 2, but not at Time 1.
  3. Performance on tests of social cognition will be positively related to executive functions at Time 1 and 2.
  4. Performance on tests of social cognition will be positively related to parent and teacher reports of social competence and environmental biographic factors (parental education and occupation) at Time 1 and 2.
* Objective: To study impairment and developmental delay in social cognition (and related cognitive functions) caused by brain damage in patients treated for a BT in childhood as compared to a reference group of chronically ill children. The focus will be on the neurocognitive basis of such deficits.
* Study design: Comparative Non-randomised Prospective International Multi-Centre Study
* Study population: 49 Children treated for a BT aged 5-13 years, 32 children diagnosed with CF aged 5-13 years and 32 healthy controls aged 5-13 years.

Social Cognition in Children Treated for a Brain Tumour

Social Cognition in Children Treated for a Brain Tumour: A Prospective Longitudinal Multi-Centre Study

Change in performance on tests of social cognition from time 1 (diagnosis) to time 2 (3 years later).

Parent and Teacher reports of social and emotional functioning from time 1 (diagnosis) to time 2 (3 years later).

The influence of individual biographical and medical characteristics (age at diagnosis, histology, sex, tumor site, treatment) on change in performance on tests of social cognition from time 1 to time 2.

Radboud University Medical Center

Universitaire Ziekenhuizen KU Leuven

Amsterdam UMC, location VUmc

University Medical Center Groningen

Clinical Neuropsychologist

AYA will complete questionnaires assessing peer versus family connectedness, peer/romantic competence, coping, distress, social support, and quality of life.A study-specific needs assessment regarding interest in social functioning interventions will also be completed.

Participants (30 on-therapy) will be interviewed to further explore aspects of peer/family connectedness and intervention interest.

AYA will complete questionnaires assessing peer versus family connectedness, peer/romantic competence, coping, distress, social support, and quality of life.A study-specific needs assessment regarding interest in social functioning interventions will also be completed.

Participants (20 off-therapy) will be interviewed to further explore aspects of peer/family connectedness and intervention interest.

Victoria W. Willard, PhD

Participants are being asked to take part in this clinical trial, a type of research study, because investigators want to learn more about the social experiences adolescents and young adults who are being treated or have been treated for cancer.

Primary Objectives

* Describe differences in social experience variables (peer connectedness, perceived social competence, parent versus peer attachment) based on treatment status: on versus off therapy.
* In on-therapy patients, describe differences in social experience variables (peer connectedness, perceived social competence, parent versus peer attachment) based on developmental stage: high school versus post-high school.

Secondary Objectives

* Assess the social support and peer interaction needs of AYA with cancer as a means of determining stakeholder interest and need for psychosocial interventions targeting social experiences.
* Using qualitative interviews, explore patient perceptions of the impact of cancer on social experiences among AYA, particularly with regards to changes in friendships as a result of the cancer diagnosis and the role of the hospital in helping or hindering friendship maintenance/development.

Exploratory Objectives

* Explore differences in social experience by demographic, disease and treatment factors, including: gender, diagnostic category (brain tumor, leukemia/lymphoma, solid tumor), late effects/symptom burden, and treatment (e.g., treatment intensity, serious medical events).
* Explore associations between perceived impact of cancer and social experience in AYA.
* Explore associations between use of social media and social experience.
* Explore associations between social experiences and overall functioning (quality of life, distress, coping).
* Explore the possibility of subclasses of AYA by using person-centered analyses to empirically derive profiles of social experience.

A mixed-methods design involving questionnaires and interviews will be used to evaluate the study objectives. AYA ages 15 to 22 will be recruited to participate. Two cohorts will be enrolled: AYA who are on-treatment, 2-12 months post-diagnosis; and AYA who are off-therapy 1 to 4 years. AYA will complete questionnaires assessing peer versus family connectedness, peer/romantic competence, coping, distress, social support, and quality of life. A study-specific needs assessment regarding interest in social functioning interventions will also be completed. If a caregiver is available, they will be asked to complete questionnaires regarding family functioning and quality of life. A subset of 50 AYA (30 on-therapy/20 off-therapy) will be interviewed to further explore aspects of peer/family connectedness and intervention interest. Analyses will focus on describing how aspects of social experiences (peer connectedness, social competence, peer versus parent attachment) differ based on treatment status (on versus off therapy) and developmental stage (high school versus post-high school), as well as potential moderators.

Two cohorts of AYA with cancer, ages 15-22, will be identified and recruited for the study: 1) patients on-therapy, 2-12 months from diagnosis; and 2) patients off- therapy 1-4 years, and ≥13 years of age at diagnosis. AYA from all diagnostic groups - brain tumor, solid tumor, leukemia/lymphoma - and developmental periods - high school, post-high school - will be targeted, and care will be taken to ensure a representative sample.

Social Experiences of Adolescents and Young Adults With Cancer

This is a self-report measure of perceptions of the relationship between an individual and their mother, father and close friends.

This 20-item self-report questionnaire assesses perceptions of peer connectedness over the past month. Items assess feelings of social connectedness, loneliness, and social isolation. Questions are answered on a 4-point Likert scale from "never" to "often," and a total score is calculated.

This is a 53-item measure for parents designed to assess the impact of a child's health condition on the family system. Six subscales are derived, including measures of the child's daily life, the parent's perceived ability to manage the condition, and, for partnered parents, how the parents work together to manage the condition.

The SPPA/EA is a self-report measure of self-competence. Multiple constructs are assessed, including social, romantic, physical, and academic competence, as well as global self-worth. Subscales assessing Social Competence, Romantic Competence and Physical Appearance are of primary interest.

This is a 5- (ages 15-17) or 8-item (ages 18+) self- report questionnaire that assesses aspects of friendship. Questions assess perceived ability to access friend and participation in activities with friends over the past month on a 5-point Likert scale from never to always. Five items are similar across the two age groups. Raw scores are converted to T-scores (M = 50, SD = 10), with higher scores indicative of more perceived friends to interact with.

This is a 5-item self-report measure that assesses an individual's perception of the impact of cancer on relevant domains: education, social interaction, career goals, romantic relationships and independent living. Items are rated on a 1-10 scale from "did not interfere/affect" to "extremely interfered/affected." The social interaction and romantic relationship items are of primary interest.

The COE is a 20-item self-report measure that assesses an individual's perception of the impact that a traumatic or significant event as had on their identity development. Participants will be asked to complete the COE based on their experiences with cancer.

The two part OSSS assesses the role of online apps or websites in an individual's perception of the support they receive from others. In the first part, participants rate the frequency that they use specific online spaces (e.g., Instagram, Twitter, Facebook) to interact with others. Space is also provided for participants to free text additional sites. In the second part, 40 items assess the types of social support individuals receive from these spaces, with four subscales derived: Esteem/Emotional Support, Social Companionship, Informational Support, and Instrumental Support. Oneline Social Support Scale-scores could range from 0 to 160 with higher scores indicating receipt of more support.

The MSPSS is a 12-item self-report questionnaire that assesses perceived reception of support from important persons - friends, family, and significant other. Questions are answered on 7-item Likert scale from "very strong disagree" to "very strongly agree." Higher scores are indicative of more social support.

The RSQ is a 57-item self-report questionnaire assessing an individual's coping with an identified stressor. For this study, cancer will be the identified stressor and separate versions of the RSQ are available for those on treatment and off treatment. Responses to Stress Questionnaire - scores range from 0 to 4 with higher scores indicating more use of that coping mechanism

Three brief self-report measures will assess symptoms of anxiety, depression, and fatigue over the past 7 days. Measures will be completed by both AYA and their caregivers, with each respondent providing indicators of their own level of distress. Raw scores are converted to T- scores (M = 50, SD = 10) with higher scores indicating greater symptoms.

The PedsQL Cancer Module is a 27-item self-report measure that assesses symptom burden and quality of life as related to cancer-specific factors, including pain, nausea, procedural anxiety, and physical appearance. AYA will complete this measure as an indicator of current cancer- related symptoms. PedsQL - scores range 0 to 100 with higher scores indicating better functioning

The PedsQL Core Module is a 23-item measure of quality of life, with both self- and proxy-report versions available. Four subscales provide two broad domains - Physical and Psychosocial Functioning - and an overall quality of life score. Raw scores undergo a linear transformation. AYA and their participating caregiver will complete this measure.

The ITR-3 is a clinician-completed rating form that provides a means of classifying the intensity of pediatric cancer treatment. Four categories are elicited: Least, Moderately, Very, and Most Intensive. This will be completed for each participant using information gathered from the medical record.

This is a new questionnaire developed specifically for this study. Participants will answer questions about their participation in current hospital activities and events as well as their interest in and feedback on future interventions. It will be analyzed at the individual item level.

A subsample of participants will complete an interview to further assess aspects of friendships and intervention interest. Participant responses will be transcribed and analyzed for themes.

Study title	NCT ID	Conditions	Eligibility	Organization
Social Cognition in Children Treated for a Brain Tumour	NCT01599052	Social Behaviou... Brain Neoplasms Cystic Fibrosis	5 Years - 12 Years	University Medical Center Groningen
Social Experiences of Adolescents and Young Adults With Cancer	NCT04328350	Childhood Cance... Social Behavior Social Competen...	15 Years - 22 Years	St. Jude Children's Research Hospital
Social Experiences of Adolescents and Young Adults With Cancer	NCT04328350	Childhood Cance... Social Behavior Social Competen...	15 Years - 22 Years	St. Jude Children's Research Hospital

Spots Global Cancer Trial Database for social competence