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Trial Title:
Engaging Parents in Neuropsychological Rehabilitation for Childhood Cancer Survivors: The ImPACT Program - A Pilot Study
NCT ID:
NCT05483166
Condition:
Pediatric Cancer
Cognitive Dysfunction
Conditions: Official terms:
Cognitive Dysfunction
Conditions: Keywords:
Pediatric Cancer
Cognitive Dysfunction
Neuropsychological Rehabilitation
Neurobehavioral Impairment
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
ImPACT
Description:
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.
Arm group label:
ImPACT program
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
• Confounding diagnosed or suspected psychiatric or medical condition unrelated to the
cancer or its treatment that might contribute to cognitive or neurobehavioral impairment
Gender:
All
Minimum age:
10 Years
Maximum age:
17 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Aarhus University
Address:
City:
Aarhus
Zip:
8000
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Cecilie R Buskbjerg, Ph.D.
Phone:
+45 29842526
Email:
cdrc@psy.au.dk
Start date:
October 1, 2022
Completion date:
December 1, 2026
Lead sponsor:
Agency:
Aarhus University Hospital
Agency class:
Other
Collaborator:
Agency:
University of Aarhus
Agency class:
Other
Source:
Aarhus University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05483166
