Executive and Socio-cognitive Functions in Survivors of Primary Brain Tumor: Impact on Patients' Quality of Life (NEUROCOG-QOL)

May 2, 2018 updated by: University Hospital, Angers

Assessment of Executive and Socio-cognitive Functions in Child and Adult Survivors of Primary Brain Tumor: Impact on Patients' and Relatives' Quality of Life.

Significant advances in primary malignant brain tumors (PBT) treatment have led to dramatically improved survival, both in children and adults. However, survival has not come without a cost and aggressive treatment methods associated with significant long-term adverse effects, often referred to as "late effects" (Panigrahy & Blüml, 2009). These effects are the medical, physical, cognitive and psychosocial sequelae associated with cancer and its treatments that generally emerge two to five years after treatment ends (e.g., Landier & Bhatia, 2008).

The most serious challenge survivors of brain tumors face may be cognitive dysfunction. One especially important cognitive domain is executive functioning, which refers to essential factors such as problem-solving, goal-directed behavior and the ability to maintain stable interpersonal relationships (Lezak et al., 2004). Despite the potential impact of executive impairments on behavioral regulation and quality of life, few studies were conducted with survivors of PBT specifically for the assessment of executive functioning. Another fundamental neuro-cognitive domain is social cognition, which refers to the ability to understand the intentions and beliefs of others (Frith & Singer, 2008). Social cognitive deficits are expected to impair autonomy and relationships, but scarce attention has been devoted to the study of social cognition in survivors of PBT and no study has attempted to compare socio-cognitive data and measures of health-related quality of life. It is noteworthy that executive function and socio-cognitive skills improve throughout childhood and adolescence, and improvements in these skills have frequently been attributed to maturation of the brain, especially the prefrontal cortex (e.g., Tamnes et al., 2010). This suggests a greater impact of the disease and its treatment on these functions in children/adolescents.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

First, the investigators will calculate the prevalence of cognitive and socio-cognitive deficits, by comparing the performances of patients (children/adolescents and adults) to normative data available for each tasks and to performances of healthy controls matched on socio-demographic criteria.

Second, the investigators will compare the neuropsychological scores for cognitive and socio-cognitive tasks to health related quality of life (HRQOL) data (composite scores and by domains). Comparisons of neuropsychological and HRQOL scores will be performed between the two populations (children / adolescents and adults).

Third, the investigators will compare the data from the two age groups for the aforementioned variables (cognitive and behavioral executive assessments, cognitive and affective TOM). The proximity of the tasks should provide valid elements of comparison. The investigators will compare the questionnaires in auto-and hetero-evaluation for each HRQOL scales, and also for executive behavioral questionnaires.

Finally, to evaluate the investigators will compare the HRQOL patients/relatives' data to measure the potential impact of the disease on HRQOL of relatives of PBT survivors and the potential link between these data.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • Recruiting
        • CHU Angers
        • Contact:
          • Didier Le Gall

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 59 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 8 and 59
  • Children/adolescents and adults who have been treated by chemotherapy and/or radiotherapy and/or neurosurgery, subsequent to the diagnosis of a primary brain tumor
  • The end of treatment must be comprised between 2 and 5 years at the time of the assessment, as argued above.

Exclusion Criteria:

  • Sensory disturbances (e.g., visual, auditory) incompatible with the achievement of the tasks
  • Language or praxis deficits inconsistent with the achievement of the tasks
  • Neurological disease other than PBT
  • secondary brain tumor
  • Psychiatric history (consultation with a psychiatrist of the University Hospital if doubt)
  • Insufficient French language proficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: child and adult survivors of brain tumor

Executive functions and social cognition will be assessed using cognitive (Stroop task, Modified Card Sorting Task, Digit spans) and behavioral (BRIEF for childrens and BRIEF-A for adults) tests.

Quality of life will be assessed by questionaires (SF-36, QLQC30-BN20 for adults and Peds-Ql for childrens)
Other: Executive functions
measures of executive functioning with tasks
Other: social cognition
measures of socio-cognitive functioning with tasks
Other: quality of life
measures of quality of life with questionnaires
Experimental: healthy controls

Executive functions and social cognition will be assessed using cognitive (Stroop task, Modified Card Sorting Task, Digit spans) and behavioral (BRIEF for childrens and BRIEF-A for adults) tests.

Quality of life will be assessed by questionaires (SF-36, QLQC30-BN20 for adults and Peds-Ql for childrens)
Other: Executive functions
measures of executive functioning with tasks
Other: social cognition
measures of socio-cognitive functioning with tasks
Other: quality of life
measures of quality of life with questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
performances in executive tasks and executive questionnaires
Time Frame: 2 years

Executive functions will be assessed using executive cognitive tasks (Stroop task for inhibition, Modified Card Sorting Task for mental flexibility, Digit spans for working memory) and questionnaires (BRIEF for childrens and BRIEF-A for adults) for executive behavioral measures.

Standardized norms in French are available for these tasks, which permit determining if the performances are pathological. So, these multiple measurements will be aggregated to determine the number of patients with pathological performances for executive tasks (tasks and questionaires).
2 years
performances in social cognition tasks
Time Frame: 2 years

The first task involves a mental representation or belief about the state of the world (eg, Samson, 2012). The items offered in this kind of task are used to assess the ability to understand that the belief to infer in a type of scenario does not correspond to the reality.

The second task will be the Faux Pas task (Stone et al., 1998). This task is composed of written scenarios and the subject must detect if someone has done or said something he should not have said- the "faux pas". If the subject detects that there was a faux pas, additional questions are asked to detect whether he/she understands the cognitive side and the emotional side of the faux pas.

Standardized norms in French are available for these tasks, which permit determining if the performances are pathological. These multiple measurements will be aggregated to determine the number of patients with pathological performances.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life questionnaires
Time Frame: 2 years

Health-related quality of life (HRQOL) will be assessed in adults with the French validated version of the 36-Item Short Form Survey (SF-36; Ware & Sherbourne 1992) and a specific questionnaire for assessing quality of life of patients with brain tumors (QLQ-C30-BN20), commonly used in the international literature (eg, Chen et al, 2012;. Pulenzas et al, 2014).

Regarding the HRQOL assessment in children, the choice fell on the Peds-Ql. The PEDS QL measures HRQOL with three major composite assessments -psychosocial, physical, and total HRQOL.

Standardized norms in French are available for questionaires, which permit determining if the performances are pathological. These measurements will be aggregated to determine the number of patients with abnormal performances for these questionaires.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Jeremy Besnard, PhD, University of Angers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

February 5, 2016

First Submitted That Met QC Criteria

February 22, 2016

First Posted (Estimate)

February 26, 2016

Study Record Updates

Last Update Posted (Actual)

May 3, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-P2015-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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