Clinical trial NCT05483166: Engaging Parents in Neuropsychological Rehabilitation for Childhood Cancer Survivors: The ImPACT Program - A Pilot 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Cancer
Cognitive Dysfunction
Keywords: Pediatric Cancer
Cognitive Dysfunction
Neuropsychological Rehabilitation
Neurobehavioral Impairment
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
First posted: 2022-08-01
Enrollment: 10
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Parent-reported neurobehavioral functioning
timeFrame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
measure: Parent-reported cognitive functioning
timeFrame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Secondary outcomes:
measure: Parent-reported neurobehavioral functioning
timeFrame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
measure: Parent-reported cognitive functioning
timeFrame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
measure: Child-reported neurobehavioral functioning
timeFrame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
measure: Child-reported neurobehavioral functioning
timeFrame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
measure: Child-reported cognitive functioning
timeFrame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
measure: Child-reported cognitive functioning
timeFrame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
measure: Parent-reported pediatric quality of life
timeFrame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
measure: Parent-reported pediatric quality of life
timeFrame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
measure: Child-reported pediatric quality of life
timeFrame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
measure: Child-reported pediatric quality of life
timeFrame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
measure: Parent-reported pediatric anxiety and depression
timeFrame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
measure: Parent-reported pediatric anxiety and depression
timeFrame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
measure: Child-reported pediatric anxiety and depression
timeFrame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
measure: Child-reported pediatric anxiety and depression
timeFrame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
measure: Parent-reported pediatric fatigue
timeFrame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
measure: Parent-reported pediatric fatigue
timeFrame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
measure: Child-reported pediatric fatigue
timeFrame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
measure: Child-reported pediatric fatigue
timeFrame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
measure: Parent sense of competence
timeFrame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
measure: Parent sense of competence
timeFrame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
measure: Parent-reported participant motivation
timeFrame: After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3)
measure: Child-reported participant motivation
timeFrame: After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3))
measure: Parent-reported participant satisfaction
timeFrame: After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3)
measure: Child-reported participant satisfaction
timeFrame: After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3)
measure: Objective cognitive functioning (Child only)
timeFrame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
measure: Objective cognitive functioning (Child only)
timeFrame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Other outcomes:
measure: Qualitative Interviews
timeFrame: 9 week after post-intervention (approximately 18 weeks after Baseline assessment (T1): Follow-up, T4)
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University
Study officials:
affiliation: University of Aarhus
name: Lisa M Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References: