An individualized neuropsychological intervention for children post brain tumor treatment
| ISRCTN | ISRCTN30985676 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30985676 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | PN21ERN/NL86240.041.24 |
| Sponsor | Princess Máxima Center |
| Funder | KWF Kankerbestrijding |
- Submission date
- 10/09/2024
- Registration date
- 04/10/2024
- Last edited
- 04/10/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims:
Children who survive brain tumors often have a hard time with thinking, emotions, or behavior. While there are treatments to help with these issues, most of them use the same approach for everyone, only focus on one type of thinking skill (such as memory), or don't involve the child's family in the treatment. This study wants to try a different approach by tailoring the treatment to each child's needs and including their families. We want to see if this helps improve the child's well-being. Specifically, we'll compare this personalized treatment to a one-size-fits-all method to see which is more effective and to understand the experiences of those involved and how easy or difficult it is to join the study.
Who can participate?
Patients aged 8-17 years, who have finished treatment for a brain tumor and have cognitive difficulties, along with a parent or caregiver.
What does the study involve?
Participants are randomly assigned to one of two groups: one receiving the individualized treatment and the other receiving the standardized intervention. Both groups receive six sessions of about 1 hour each over 3 months, either in-person or online. Both groups start the first session by setting goals for the treatment. The second session consists of a general psycho-education on the neuropsychological consequences of brain tumor (treatment). Sessions 3-5 consist of modules tailored to the child's needs/goals in the individualized arm, while the standardized arm follows preset modules addressing common neuropsychological symptoms after brain tumors. The sixth and last session is a concluding session. Sessions focus on psychoeducation, tips and strategy training to compensate for neuropsychological difficulties.
Participants complete tests, questionnaires and interviews before, after, and 12 months after the intervention to assess changes in goal attainment, cognition, social-emotional, quality of life and family/parent domains.
What are the possible benefits and risks of participating?
The treatment techniques are non-invasive and have been used safely before. Participation involves treatment and completing tests and questionnaires, which requires additional time. Some patients and their parents/caregivers complete neuropsychological tasks and questionnaires as part of standard care, which therefore minimizes the time burden. Participating in this study carries no expected risks. The treatment might help reduce the experience of neuropsychological problems. Patients/parents receive a summary of assessment results and appropriate referrals if needed. Taking part in this study will help us learn more about how to treat neuropsychological problems after a brain tumor.
Where is the study run from?
Princess Máxima Center Utrecht (The Netherlands).
When is the study starting and how long is it expected to run for?
July 2023 to October 2027
Who is funding the study?
The Dutch Cancer Society (DCS; in Dutch: 'KWF Kankerbestrijding') (The Netherlands)
Who is the main contact?
Marita Partanen, M.H.Partanen@prinsesmaximacentrum.nl
Contact information
Public, Scientific, Principal investigator
Heidelberglaan 25
Utrecht
3584 CS
Netherlands
 ORCID ID |
0000-0003-1018-9778 |
|---|---|
| Phone | +31 (0)88 97 25 844 |
| m.h.partanen@prinsesmaximacentrum.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-center interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | ERNIE: Evaluating Response to iNdividualized neuropsychological IntervEntion for children with brain tumors |
| Study acronym | ERNIE |
| Study objectives | The efficacy of individualized versus standardized neuropsychological interventions for children post brain tumor treatment has not been studied before. Based on previous research comparing individualized/tailored intervention approaches to standardized intervention approaches, we expect that the individualized intervention leads to greater changes in goal attainment than the standardized intervention. |
| Ethics approval(s) |
Approved 20/08/2024, Netherlands Medical Ethics Committee (Medisch-Ethische Toetsingcommissie NedMec) (Heidelberglaan 100, Utrecht, 3584 CX, Netherlands; +31 (0)88 7556376; metc@nedmec.nl), ref: 24-131/G; NL86240.041.24 |
| Health condition(s) or problem(s) studied | Neuropsychological problems in children who finished treatment for a primary brain tumor |
| Intervention | In this RCT, participants and their parents will be randomized using an online tool to the individualized intervention arm or standardized intervention arm. Participants will be blinded to their treatment condition. Both intervention arms consist of six sessions of approximately 1 hour over 3 months, either in-person or online, depending on preference. Trained psychologists serve as interventionists, with support from a PhD student. Both intervention groups will start the first session with goal setting followed by the second session that consists of a general psycho-education module. Sessions 3-5 will consist of modules tailored to the child's needs/goals in the individualized arm, while the standardized arm follows preset modules addressing common neuropsychological symptoms after brain tumors. The sixth and final session of the neuropsychological intervention will serve as a concluding session, encompassing a summary of the content covered throughout the intervention, facilitating closure, and providing an opportunity for discussion and reflection. Sessions focus on psychoeducation tips and strategy training (adapted from previous intervention studies), promoting patient and parent collaboration. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Goal attainment is measured using Goal Attainment Scaling (GAS) at baseline, 3 months and 12 months follow-up |
| Key secondary outcome measure(s) |
1. Neuropsychological assessment tasks: |
| Completion date | 01/10/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 17 Years |
| Sex | All |
| Target sample size at registration | 144 |
| Key inclusion criteria | 1. Age between 8-17 years old 2. Diagnosed with a primary brain tumor 3. Completed treatment for a primary brain tumor (patients who are considered “wait and see” and have not received treatment will also be eligible) 4. Experiencing cognitive problems (≥1SD below normative mean or estimated IQ [EIQ]) on ≥2 scores, including WISC-V/WAIS-IV, IDS2, CPT3, 15WT tests and/or self- or proxy-reported PedsQL Fatigue or BRIEF-2 questionnaires) 5. A parent/caregiver who they have regular contact (in order to participate in the intervention with them) |
| Key exclusion criteria | 1. No signed informed consent (either by patient and/or parents/legal guardian) 2. Cannot complete neuropsychological assessment or questionnaires because they do not speak/understand the Dutch language 3. Currently receiving palliative/end-of-life care 4. Currently receiving other neuropsychological treatment 5. Severe developmental or psychiatric disorders and thus alternative interventions would be needed (e.g., autism spectrum disorder, schizophrenia, major depressive disorder) 6. Significant sensory, motor, or developmental problems and thus alternative neuropsychological assessments would be needed (i.e., blindness, deafness, profound developmental delay FSIQ <55) 7. Treating physician or psychologist advises against inclusion |
| Date of first enrolment | 01/10/2024 |
| Date of final enrolment | 01/10/2026 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Utrecht
3584 CS
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/09/2024: Study's existence confirmed by Netherlands Medical Ethics Committee (Medisch-Ethische Toetsingcommissie NedMec).
