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Pediatric CancerNCT05483166

Engaging Parents in Neuropsychological Rehabilitation for Childhood Cancer Survivors: The ImPACT Program - A Pilot Study

A study testing ImPACT in people with Pediatric Cancer and Cognitive Dysfunction, run by Aarhus University Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the present pilot study is to evaluate the feasibility, acceptability, and preliminary efficacy of a novel, context-sensitive neuropsychological rehabilitation intervention for childhood cancer survivors and their families. Read more about this study

Who is it for?
Ages 10 to 17 years
Conditions the study is for
Pediatric Cancer, Cognitive Dysfunction
What is being tested?
ImPACT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteDenmark
Study dates
1 Oct 2022to 26 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Cancer diagnosis of a leukemia, lymphoma, or central nervous system tumor
  • Completed primary treatment at least 6 months ago
  • Not terminally ill
  • Attend school
  • Living with one or more parents who speak Danish and are willing to co-participate
  • Screened as having parent-reported cognitive and/or neurobehavioral impairment

Who cannot join

  • Confounding diagnosed or suspected psychiatric or medical condition unrelated to the cancer or its treatment that might contribute to cognitive or neurobehavioral impairment

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Aarhus University

    Aarhus, 8000

Other trials in Denmark

About this study

Official title: Engaging Parents in Neuropsychological Rehabilitation for Childhood Cancer Survivors: The "I'm Aware: Parents and Children Together" (ImPACT) Program - A Pilot Study

The aim of the present pilot study is to evaluate the feasibility, acceptability, and preliminary efficacy of a novel, context-sensitive neuropsychological rehabilitation intervention for childhood cancer survivors and their families.

Read the detailed description

Cognitive impairment is the most common late effect in childhood cancer survivors, and despite the negative effects of these symptoms on quality of life, scholastic achievement and long-term socioeconomic outcomes, there continues to be no "gold standard" treatment for childhood cancer survivors with cognitive impairment.

Indeed, there is a dearth of research on interventions to treat cognitive impairment in childhood cancer survivors, and the relatively few studied interventions have proven limited effects. Arguably, four key elements are missing from a majority of studied interventions:1) transfer of learning to real-world functional outcomes, 2) awareness training to enhance compensatory strategy use, 3) inclusion of parents that could enhance transfer of learning to the home, and 4) recognition of the inter-related nature of cognitive, neurobehavioral, and psychological functions.

The "I'M aware: Parents and Children Together (ImPACT)" program is a novel, context-sensitive neuropsychological rehabilitation intervention that targets the above mentioned missing elements in previous rehabilitation efforts. The present pilot study aims to assess the feasibility, acceptability, and preliminary efficacy of this program in childhood cancer survivors with cognitive impairment in preparation for a large-scale randomized controlled trial.

Being tested
ImPACT
Keywords
Pediatric Cancer, Cognitive Dysfunction, Neuropsychological Rehabilitation, Neurobehavioral Impairment
Medical subject headings
Neoplasms, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ImPACTBehavioural

    During the ImPACT program, the childhood cancer survivor and at least one parent collaborates on:

    1. Becoming aware of the child's core strengths and difficulties
    2. Helping the child to be optimally responsive to the guidance of the parent(s), and
    3. Creating compensatory strategies to respond to real-world manifestations of the child's difficulties and helping the child implement these strategies at home.
Study groups in NCT05483166
Study groupRoleWhat they receive
ImPACT programExperimentalThe ImPACT program consists of 8 weekly 1-hour sessions with homework between sessions.
Receives: Behavioral: ImPACT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Parent-reported neurobehavioral functioning

    The parent-report screening version of the Behavior Rating Inventory of Executive Function 2nd Edition (BRIEF-2). 12 items: answer format range: 1-3; total score range: 12-36. Higher score indicates more impairment.

    Measured: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)

  2. Parent-reported cognitive functioning

    The parent-report version of the Pediatric Perceived Cognitive Function (PedsPCF) Short Form. 7 items: answer format range 1-5; total score range: 7-35. Lower score indicates more impairment.

    Measured: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)

Secondary outcomes (26)
  1. Parent-reported neurobehavioral functioning

    The parent-report version of the Behavior Rating Inventory of Executive Function 2nd Edition (BRIEF-2). 63 items: answer format range: 1-3; total score range: 63-189. Higher score indicates more impairment.

    Measured: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)

  2. Parent-reported cognitive functioning

    The parent-report version of the Pediatric Perceived Cognitive Function (PedsPCF) Short Form. 7 items: answer format range 1-5; total score range: 7-35. Lower score indicates more impairment.

    Measured: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)

  3. Child-reported neurobehavioral functioning

    The child-report version of the Behavior Rating Inventory of Executive Function 2nd Edition (BRIEF-2). 55 items: answer format range: 1-3; total score range: 55-165. Higher score indicates more impairment.

    Measured: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)

  4. Child-reported neurobehavioral functioning

    The child-report version of the Behavior Rating Inventory of Executive Function 2nd Edition (BRIEF-2). 55 items: answer format range: 1-3; total score range: 55-165. Higher score indicates more impairment.

    Measured: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)

  5. Child-reported cognitive functioning

    The child-report version of the Pediatric Perceived Cognitive Function (PedsPCF) Short Form. 7 items: answer format range 1-5; total score range: 7-35. Lower score indicates more impairment.

    Measured: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)

  6. Child-reported cognitive functioning

    The child-report version of the Pediatric Perceived Cognitive Function (PedsPCF) Short Form. 7 items: answer format range 1-5; total score range: 7-35. Lower score indicates more impairment.

    Measured: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)

  7. Parent-reported pediatric quality of life

    The parent-report version of the Pediatric Quality of Life (PedsQL) Core and Cancer scale. 23 items for the Core Scale, 25 items for the Cancer Scale: answer format range: 0-4; total score range: 0-100 (both scales). Lower scores indicate more impairment.

    Measured: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)

  8. Parent-reported pediatric quality of life

    The parent-report version of the Pediatric Quality of Life Inventory (PedsQL) Core and Cancer scale. 23 items for the Core Scale, 25 items for the Cancer Scale: answer format range: 0-4; total score range: 0-100 (both scales). Lower scores indicate lower quality of life.

    Measured: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)

  9. Child-reported pediatric quality of life

    The child-report version of the Pediatric Quality of Life (PedsQL) Core and Cancer scale. 23 items for the Core Scale, 25 items for the Cancer Scale: answer format range: 0-4; total score range: 0-100 (both scales). Lower scores indicate more impairment.

    Measured: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)

  10. Child-reported pediatric quality of life

    The child-report version of the Pediatric Quality of Life (PedsQL) Core and Cancer scale. 23 items for the Core Scale, 25 items for the Cancer Scale: answer format range: 0-4; total score range: 0-100 (both scales). Lower scores indicate more impairment.

    Measured: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)

  11. Parent-reported pediatric anxiety and depression

    The parent-report version of the Revised Children's Anxiety and Depression Scale (CADS) Short Form. 47 items: answer format range: 0-3; total score range: 0-27 (social phobia and panic disorder subscales), 0-30 (major depressive disorder subscale), 0-21 (social anxiety disorder subscale), 0-18 (generalized anxiety disorder and obsessive compulsive disorder subscales). Higher scores indicate more anxiety and depression.

    Measured: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)

  12. Parent-reported pediatric anxiety and depression

    The parent-report version of the Revised Children's Anxiety and Depression Scale (CADS) Short Form. 47 items: answer format range: 0-3; total score range: 0-27 (social phobia and panic disorder subscales), 0-30 (major depressive disorder subscale), 0-21 (social anxiety disorder subscale), 0-18 (generalized anxiety disorder and obsessive compulsive disorder subscales). Higher scores indicate more anxiety and depression.

    Measured: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)

  13. Child-reported pediatric anxiety and depression

    The child-report version of the Revised Children's Anxiety and Depression Scale (CADS) Short Form. 47 items: answer format range: 0-3; total score range: 0-27 (social phobia and panic disorder subscales), 0-30 (major depressive disorder subscale), 0-21 (social anxiety disorder subscale), 0-18 (generalized anxiety disorder and obsessive compulsive disorder subscales). Higher scores indicate more anxiety and depression.

    Measured: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)

  14. Child-reported pediatric anxiety and depression

    The child-report version of the Revised Children's Anxiety and Depression Scale (CADS) Short Form. 47 items: answer format range: 0-3; total score range: 0-27 (social phobia and panic disorder subscales), 0-30 (major depressive disorder subscale), 0-21 (social anxiety disorder subscale), 0-18 (generalized anxiety disorder and obsessive compulsive disorder subscales). Higher scores indicate more anxiety and depression.

    Measured: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)

  15. Parent-reported pediatric fatigue

    The parent-report version of the Pediatric Quality of Life - Multidimensional Fatigue Scale (PedsQL-MFS). 18 items: answer format range 0-4; total score range: 0-100. Lower score indicates more fatigue.

    Measured: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)

  16. Parent-reported pediatric fatigue

    The parent-report version of the Pediatric Quality of Life - Multidimensional Fatigue Scale (PedsQL-MFS). 18 items: answer format range 0-4; total score range: 0-100. Lower score indicates more fatigue.

    Measured: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)

  17. Child-reported pediatric fatigue

    The child-report version of the Pediatric Quality of Life - Multidimensional Fatigue Scale (PedsQL-MFS). 18 items: answer format range 0-4; total score range: 0-100. Lower score indicates more fatigue.

    Measured: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)

  18. Child-reported pediatric fatigue

    The child-report version of the Pediatric Quality of Life - Multidimensional Fatigue Scale (PedsQL-MFS). 18 items: answer format range 0-4; total score range: 0-100. Lower score indicates more fatigue.

    Measured: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)

  19. Parent sense of competence

    The Parenting Sense of Competence Scale (PSC scale).17 items: answer format range 1-6; total score range: 16-102. Higher score indicates more competence.

    Measured: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)

  20. Parent sense of competence

    The Parenting Sense of Competence Scale (PSC scale). 17 items: answer format range 1-6; total score range: 16-102. Higher score indicates more competence.

    Measured: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)

  21. Parent-reported participant motivation

    The 7-item interest/enjoyment subscale of the Intrinsic Motivation Inventory (IMI). 7 items: answer format range 1-7; total score range: 1-7. Higher score indicates more motivation.

    Measured: After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3)

  22. Child-reported participant motivation

    The 7-item interest/enjoyment subscale of the Intrinsic Motivation Inventory (IMI). 7 items: answer format range 1-7; total score range: 1-7. Higher score indicates more motivation.

    Measured: After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3))

  23. Parent-reported participant satisfaction

    The Client Satisfaction Questionnaire (CSQ-8). 8 items: answer format range 1-4; total score range: 8-32. Higher score indicates better satisfaction.

    Measured: After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3)

  24. Child-reported participant satisfaction

    The Client Satisfaction Questionnaire (CSQ-8). 8 items: answer format range 1-4; total score range: 8-32. Higher score indicates better satisfaction.

    Measured: After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3)

  25. Objective cognitive functioning (Child only)

    Standard neuropsychological test battery. Different scoring formats.

    Measured: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)

  26. Objective cognitive functioning (Child only)

    Standard neuropsychological test battery. Different scoring formats.

    Measured: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2022
  2. Study start1 Oct 2022
  3. Primary completion26 Jun 2026
  4. Study completion26 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05483166
Sponsor's protocol ID
ImPACT Child
Status last verified
Jan 2024
First submitted
19 Jul 2022
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ImPACT in people with Pediatric Cancer and Cognitive Dysfunction, run by Aarhus University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parent-reported neurobehavioral functioning (time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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