Engaging Parents in Neuropsychological Rehabilitation for Childhood Cancer Survivors: The ImPACT Program - A Pilot Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ImPACT.
- Who it may be relevant to
- Registry conditions: Pediatric Cancer, Cognitive Dysfunction. Basic parameters: 10 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Engaging Parents in Neuropsychological Rehabilitation for Childhood Cancer Survivors: The "I'm Aware: Parents and Children Together" (ImPACT) Program - A Pilot Study
Overview
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.
Interventions
- Behavioral ImPACT
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.
Primary outcome measures
- Parent-reported neurobehavioral functioning [Time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)]
- Parent-reported cognitive functioning [Time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)]
Secondary outcome measures (12)
- Parent-reported neurobehavioral functioning [Time frame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)]
- Parent-reported cognitive functioning [Time frame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)]
- Child-reported neurobehavioral functioning [Time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)]
- Child-reported neurobehavioral functioning [Time frame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)]
- Child-reported cognitive functioning [Time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)]
- Child-reported cognitive functioning [Time frame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)]
- Parent-reported pediatric quality of life [Time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)]
- Parent-reported pediatric quality of life [Time frame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)]
- Child-reported pediatric quality of life [Time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)]
- Child-reported pediatric quality of life [Time frame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)]
- Parent-reported pediatric anxiety and depression [Time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)]
- Parent-reported pediatric anxiety and depression [Time frame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Aarhus University — Aarhus
Identifiers
NCT: NCT05483166 · ImPACT Child