NCT05483166

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress86%
Oct 2022Dec 2026

First Submitted

Initial submission to the registry

July 19, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 1, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

2.7 years

First QC Date

July 19, 2022

Last Update Submit

January 31, 2024

Conditions

Pediatric CancerCognitive Dysfunction

Keywords

Pediatric CancerCognitive DysfunctionNeuropsychological RehabilitationNeurobehavioral Impairment

Outcome Measures

Primary Outcomes (2)

  • 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.

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

  • 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.

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

Secondary Outcomes (26)

  • Parent-reported neurobehavioral functioning

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

  • Parent-reported cognitive functioning

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

  • Child-reported neurobehavioral functioning

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

  • Child-reported neurobehavioral functioning

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

  • Child-reported cognitive functioning

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

  • +21 more secondary outcomes

Other Outcomes (1)

  • Qualitative Interviews

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

Study Arms (1)

ImPACT program

EXPERIMENTAL

The ImPACT program consists of 8 weekly 1-hour sessions with homework between sessions.

Behavioral: ImPACT

Interventions

ImPACTBEHAVIORAL

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.

ImPACT program

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University

Aarhus, 8000, Denmark

RECRUITING

MeSH Terms

Conditions

NeoplasmsCognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Lisa M Wu, PhD

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa M Wu, PhD

CONTACT

+45 87 15 37 48lisa.wu@oncology.au.dk

Cecilie R Buskbjerg, PhD

CONTACT

+4529842526cdrc@psy.au.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 19, 2022

First Posted

August 1, 2022

Study Start

October 1, 2022

Primary Completion

June 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

February 1, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)