The proposed study aims to examine the efficacy and process of an individualized (vs. standardized), comprehensive and family-centered neuropsychological intervention for pediatric brain tumor patients experiencing neuropsychological problems. The…
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
As noted above, the same study parameters are used for both the primary and
secondary objectives and therefore are described together here. The difference
is that the primary objective uses parameters from the post-intervention phase
(T2); whereas the secondary objective uses parameters from all phases
(T1/T2/T3).
The primary outcome measure will be goal attainment scaling (GAS), which is
assessed through parent and patient interview. This method allows for scoring
and tracking of an individual*s goals, but in a standardized format. Therefore,
each participant has their own outcome measure, but the scaling is the same
across participants to allow for statistical comparisons (i.e., T-score with
M=50, SD=10). GAS scoring will be completed for both intervention groups,
following established guidelines46.
Secondary outcome
Measurement of goal satisfaction through the Canadian Occupational Performance
Measure (COPM).
Measurements of daily functioning, cognitive, socio-emotional, quality of life,
and family/parental domains > Neuropsychological tasks and questionnaires. See
protocol table 2 for measurement instruments.
Other parameters: Demographic/clinical data, medical history, family structure
or support resources.
Tertiary research parameters/endpoints: process evaluation (recruitment,
accuracy and early-stage data collection, implementation, experiences, and
facilitators/barriers)
Background summary
With advances in treatment, 5-year survival rates for pediatric brain tumors
are ~75% and thus the number of survivors is increasing worldwide. However, up
to 50% of patients and survivors have neuropsychological difficulties that can
impact their daily functioning and quality of life. For example, they may have
attention or memory difficulties that impact their ability to complete
schoolwork, interact with peers, or participate in activities across home,
school, and community settings. Given the large impact on the brain tumor
survivor and family, interventions that decrease the burden of these challenges
are essential for improving quality of life for these children.
Previous intervention studies have attempted to improve elements of children*s
functioning, such as through computerized cognitive training12 or medications
to improve attention skills or cognitive-behavioral therapy to diminish anxiety
symptoms. The current available interventions, however, have important
limitations. For example, computerized training may not generalize to
real-world tasks or parents may be hesitant to use medications for their child.
Parents/caregivers have also not always been included within intervention
studies, but they are essential partners to assist with treatment adherence and
maintenance of skills. Also, the strongest evidence for efficacy with pediatric
acquired brain injury groups have included the family/caregiver in the
intervention, which is consistent with systems theory and family-centered
approaches. Finally, most interventions target one neuropsychological domain,
but may lead to differences in outcomes given the variability between
individual children and families. Therefore, these results suggest that a *one
size fits all* intervention approach may not be suitable for pediatric brain
tumor groups due to their complex and individual needs.
In recent years, there has been an increased focus on personalized or precision
treatment, particularly in oncology and rehabilitation. Personalized treatment
may also be important in pediatric or adult neuropsychological care, such as
matching treatments to the personal characteristics of an individual patient
and family. A family-centered and personalized approach that targets
neuropsychological difficulties may be the most effective method for improving
outcomes for children with complex needs, including pediatric brain tumors.
Recent reviews also highlight the need for multicomponent interventions that
include family members, however, this type of family-centered and comprehensive
neuropsychological intervention has not been systematically evaluated.
This proposal will evaluate the efficacy and process of an individualized and
comprehensive neuropsychological intervention compared to a standardized
neuropsychological intervention, using a randomized control trial (RCT) design.
Results will provide essential knowledge about how to target interventions on
an individual level, which will help to improve daily functioning and quality
of life in this vulnerable group of children.
Study objective
The proposed study aims to examine the efficacy and process of an
individualized (vs. standardized), comprehensive and family-centered
neuropsychological intervention for pediatric brain tumor patients experiencing
neuropsychological problems. The intervention sessions will be completed within
3 months and will follow an individualized format (based on
individually-designed program) or a standardized format (based on
pre-determined program). This intervention offers both patients and parents
tools for improving neuropsychological functioning, with the overall aim of
improving quality of life of the child.
Primary Objective:
Immediate efficacy:
• The primary research question is whether an individualized neuropsychological
intervention leads to greater changes in goal attainment and satisfaction and
broader neuropsychological functioning, immediately after the intervention,
when compared to a standardized intervention.
Secondary Objectives:
Maintenance:
• A secondary research question is whether an individualized neuropsychological
intervention leads to greater maintenance of changes in goal attainment and
satisfaction and broader neuropsychological functioning when compared to a
standardized intervention at the follow-up time point (12 months after
inclusion).
Clinical significance:
• The other secondary research question if to examine the clinical significance
of goal attainment and satisfaction and neuropsychological changes at the
follow-up time point (12 months), including effect sizes and a reliable change
index.
Tertiary Objectives:
Process:
• The tertiary research questions are to examine the process of the
neuropsychological interventions, including the completion of intervention
materials, dose, reach, costs of the intervention, experiences of families and
interventionists, and facilitators and barriers to implementation.
• An exploratory analysis will examine whether there are factors that impact
the completion of intervention materials, dose, reach, costs of the
intervention, experiences of families and interventionists, and
facilitators/barriers to implementation.
Study design
Monocenter prospective randomized controlled intervention study. The
interventionists will not be blinded to the randomization, as this is not
feasible with the current design. Patients will be blinded to the
randomization/which group they are in.
Intervention
In both the individualized and standardized interventions, cognitive and
socio-emotional domains are addressed, with a maximum of 3 goals per patient.
The intervention team provides psycho-education and strategy training, enabling
patients and parents to learn skills to enhance daily functioning. Both
intervention groups follow a session schedule (6 sessions) over 3 months,
partly conducted in the hospital and/or online (as needed). The individualized
intervention is tailored to neuropsychological profiles and patient goals,
whereas the standardized intervention group receives a predetermined set of
modules. The focus is on explicitly linking intervention content to goals. This
includes psycho-education about potential consequences of brain injury,
followed by strategy training and practical application of learned skills.
Materials are specifically compiled for the research based on existing
programs.
Study burden and risks
The risks associated with participation can be considered negligible as the
intervention is non-pharmacological, and uses elements from previously
established psychological interventions. Neuropsychological tests and
questionnaires are non-invasive and play-based for the youngest children.
Burden is considered minimal, as questionnaires can be completed from home,
testing schedules are flexible, and patients are provided with breaks when
needed.
Heidelberglaan 25
Utrecht 3584 CS
NL
Heidelberglaan 25
Utrecht 3584 CS
NL
Listed location countries
Age
Inclusion criteria
Age between 8-17 years old
Diagnosed with a primary brain tumor
Completed treatment for a primary brain tumor (patients who are considered
*wait and see* and have not received treatment will also be eligible)
Experiencing cognitive problems (>=1SD below normative mean or >=1SD change over
time on cognitive tests or cognitive questionnaires)
A parent/caregiver who they have regular contact with to participate with them
Exclusion criteria
No signed informed consent (either by patient and/or parents/legal guardian)
Cannot complete neuropsychological assessment or questionnaires because they do
not speak/understand the Dutch language
Currently receiving palliative/end-of-life care
Currently receiving other neuropsychological treatment
• Severe developmental or psychiatric disorders and thus alternative
interventions would be needed (e.g., autism spectrum disorder, schizophrenia,
major depressive disorder)
Significant sensory, motor, or developmental problems and thus alternative
neuropsychological assessments would be needed (i.e., blindness, deafness,
profound developmental delay FSIQ <55)
• Treating physician or psychologist advises against inclusion
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL86240.041.24 |
| Other | Volgt na METC goedkeuring |