Contextualized Neuropsychological Rehabilitation for CNS Cancer Survivors: The ImPACT Program

NCT ID: NCT05858359

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2025-06-24

Brief Summary

The aim of the present randomized-controlled study is to evaluate the feasibility, acceptability, and preliminary efficacy of a novel, context-sensitive neuropsychological rehabilitation intervention for brain cancer survivors.

Detailed Description

Cognitive impairment is the most common late effect in brain cancer survivors, with profound negative effects on quality of life, work ability, and socioeconomic outcomes. Still, there is no gold standard approach to treating cognitive impairment in brain cancer survivors. Furthermore, there is a dearth of research on interventions to treat cognitive impairment in brain 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 carers 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: Patients and Carers Together (ImPACT)" program is a novel, context-sensitive neuropsychological rehabilitation intervention that targets the above mentioned missing elements in previous rehabilitation efforts. The present feasibility randomized-controlled study aims to evaluate the feasibility, acceptability, and preliminary efficacy of this program in brain cancer survivors with cognitive impairment in preparation for a subsequent large-scale randomized controlled trial.

Conditions

Brain Cancer; Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• 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 program

Intervention Type: BEHAVIORAL

During the ImPACT program, the brain cancer survivor and a carer collaborate on:

1. Becoming aware of the patient's core strengths and difficulties

2. Helping the patient to be optimally responsive to the guidance of the carer, and

3. Creating compensatory strategies to respond to real-world manifestations of the patient's difficulties and helping the patient implement these strategies at home.

Waitlist

Waitlist control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ImPACT program

During the ImPACT program, the brain cancer survivor and a carer collaborate on:

1. Becoming aware of the patient's core strengths and difficulties

2. Helping the patient to be optimally responsive to the guidance of the carer, and

3. Creating compensatory strategies to respond to real-world manifestations of the patient's difficulties and helping the patient implement these strategies at home.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diagnosis of brain cancer
• Completed primary treatment at least 6 months ago
• Medically stable
• Speaks and understand Danish
• Living with a carer aged 18 or over, who also speaks and understands Danish and consents to participate in the study alongside the patient

Exclusion Criteria

• Confounding diagnosed or suspected psychiatric or medical condition unrelated to the cancer or its treatment

• Minimum Eligible Age: 18 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

Aarhus University Hospital

Locations

Aarhus University Hospital

Aarhus, , Denmark

Countries

Denmark

Other Identifiers

ImPACT Adult

Identifier Type: -

Identifier Source: org_study_id