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

NCT ID: NCT05483166

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2026-12-01

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.

Conditions

Pediatric Cancer; Cognitive Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ImPACT program

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

Group Type: EXPERIMENTAL

ImPACT

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lisa Maria Wu

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lisa M Wu, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Locations

Aarhus University

Aarhus, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Lisa M Wu, PhD

Role: CONTACT

lisa.wu@oncology.au.dk

+45 87 15 37 48

Cecilie R Buskbjerg, PhD

Role: CONTACT

cdrc@psy.au.dk

+4529842526

Facility Contacts

Cecilie R Buskbjerg, Ph.D.

Role: primary

cdrc@psy.au.dk

+45 29842526

Other Identifiers

ImPACT Child

Identifier Type: -

Identifier Source: org_study_id