Contextualized Neuropsychological Rehabilitation for CNS Cancer Survivors: The ImPACT Program (ImPACT)

September 30, 2025 updated by: Lisa Maria Wu, Aarhus University Hospital

Contextualized Neuropsychological Rehabilitation for CNS Cancer Survivors: The "I'm Aware: Patients and Carers Together" (ImPACT) Program"

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8270
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ImPACT program
The ImPACT program consists of 8 weekly 1-hour sessions with homework between sessions.
Behavioral: 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.
No Intervention: Waitlist
Waitlist control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported cognitive functioning
Time Frame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
The Patients Assessment of Own Functioning Inventory (PAOFI). 33 items: answer format range 1-6; total score range: 0-33. Higher score indicates more impairment.
Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Carer-reported cognitive functioning
Time Frame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
The Patients Assessment of Own Functioning Inventory (PAOFI) modified to informant version. 33 items: answer format range 1-6; total score range: 0-33. Higher score indicates more impairment.
Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Self-reported neurobehavioral functioning
Time Frame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
The self-report version of the Frontal Systems Behavior Scale (FrSBe). 46 items: answer format range 1-5; total score range: 46-230. Higher score indicates more impairment.
Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Carer-reported neurobehavioral functioning
Time Frame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
The carer-report version of the Frontal Systems Behavior Scale (FrSBe). 46 items: answer format range 1-5; total score range: 46-230. Higher score indicates more impairment.
Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported cognitive functioning
Time Frame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
The Patients Assessment of Own Functioning Inventory (PAOFI). 33 items: answer format range 1-6; total score range: 0-33. Higher score indicates more impairment.
Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Carer-reported cognitive functioning
Time Frame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
The Patients Assessment of Own Functioning Inventory (PAOFI) modified to informant version. 33 items: answer format range 1-6; total score range: 0-33. Higher score indicates more impairment.
Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Self-reported neurobehavioral functioning
Time Frame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
The self-report version of the Frontal Systems Behavior Scale (FrSBe). 46 items: answer format range 1-5; total score range: 46-230. Higher score indicates more impairment.
Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Carer-reported neurobehavioral functioning
Time Frame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
The carer-report version of the Frontal Systems Behavior Scale (FrSBe). 46 items: answer format range 1-5; total score range: 46-230. Higher score indicates more impairment.
Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Objective cognitive functioning (Neuropsychological tests; Patient only)
Time Frame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Global composite z-score based on the HVLT-R; Trail-making tests A and B; WAIS-IV Coding, Digit Span, Verbal Fluency; Conner's Continuous Performance Test III.
Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Objective cognitive functioning (Neuropsychological tests; Patient only)
Time Frame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Global composite z-score based on the HVLT-R; Trail-making tests A and B; WAIS-IV Coding, Digit Span, Verbal Fluency; Conner's Continuous Performance Test III.
Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Premorbid intellectual functioning (Patient only)
Time Frame: Baseline (T1)
WAIS-IV Information subtest. 26 items; answer format range 0-1; total score range: 0-26. Higher score indicates higher premorbid intellectual functioning.
Baseline (T1)
Self-reported fatigue
Time Frame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
The Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-Fatigue). 13 items: answer format range 0-4; total score range: 0-52. Lower score indicates more fatigue.
Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Carer-reported fatigue
Time Frame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
The Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-Fatigue) modified to informant version. 13 items: answer format range 0-4; total score range: 0-52. Lower score indicates more fatigue.
Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Self-reported fatigue
Time Frame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
The Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-Fatigue). 13 items: answer format range 0-4; total score range: 0-52. Lower score indicates more fatigue.
Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Carer-reported fatigue
Time Frame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
The Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-Fatigue) modified to informant version. 13 items: answer format range 0-4; total score range: 0-52. Lower score indicates more fatigue.
Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Self-reported mental fatigue
Time Frame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
The Mental Fatigue Scale (MFS). 15 items: answer format range 0-3; total score range: 0-45. Higher score indicates more mental fatigue.
Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Carer-reported mental fatigue
Time Frame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
The Mental Fatigue Scale (MFS) modified to informant version. 15 items: answer format range 0-3; total score range: 0-45. Higher score indicates more mental fatigue.
Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Self-reported mental fatigue
Time Frame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
The Mental Fatigue Scale (MFS). 15 items: answer format range 0-3; total score range: 0-45. Higher score indicates more mental fatigue.
Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Carer-reported mental fatigue
Time Frame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
The Mental Fatigue Scale (MFS) modified to informant version. 15 items: answer format range 0-3; total score range: 0-45. Higher score indicates more mental fatigue.
Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Depression (patient only)
Time Frame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
The Center for Epidemiologic Studies Depression Scale (CESD). 20 items: answer format range 0-3; total score range: 0-60. Higher score indicates more depression.
Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Depression (patient only)
Time Frame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
The Center for Epidemiologic Studies Depression Scale (CESD). 20 items: answer format range 0-3; total score range: 0-60. Higher score indicates more depression.
Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Self-reported health-related quality of life
Time Frame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
The Functional Assessment of Cancer Therapy-Brain (FACT-Br). 50 items; answer format range 0-4; total score range: 0-200. Higher score indicates better health-related quality of life.
Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Carer-reported health-related quality of life
Time Frame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
The Functional Assessment of Cancer Therapy-Brain (FACT-Br) modified to informant version. 50 items; answer format range 0-4; total score range: 0-200. Higher score indicates better health-related quality of life.
Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Self-reported health-related quality of life
Time Frame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
The Functional Assessment of Cancer Therapy-Brain (FACT-Br). 50 items; answer format range 0-4; total score range: 0-200. Higher score indicates better health-related quality of life.
Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Carer-reported health-related quality of life
Time Frame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
The Functional Assessment of Cancer Therapy-Brain (FACT-Br) modified to informant version. 50 items; answer format range 0-4; total score range: 0-200. Higher score indicates better health-related quality of life.
Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Self-reported community integration
Time Frame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
The self-report version of the Community Integration Questionnaire Revised (CIQ-R). 18 items: answer format range 0-2; total score range: 0-35. Higher score indicates more community integration.
Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Carer-reported community integration
Time Frame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
The carer-report version of the Community Integration Questionnaire Revised (CIQ-R). 18 items: answer format range 0-2; total score range: 0-35. Higher score indicates more community integration.
Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Self-reported community integration
Time Frame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
The self-report version of the Community Integration Questionnaire Revised (CIQ-R). 18 items: answer format range 0-2; total score range: 0-35. Higher score indicates more community integration.
Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Carer-reported community integration
Time Frame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
The self-report version of the Community Integration Questionnaire Revised (CIQ-R). 18 items: answer format range 0-2; total score range: 0-35. Higher score indicates more community integration.
Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Insomnia
Time Frame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
The Insomnia Severity Index (ISI). 7 items; answer format range: 0-4; total score range: 0-28. Higher score indicates more insomnia.
Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Insomnia
Time Frame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
The Insomnia Severity Index (ISI). 7 items; answer format range: 0-4; total score range: 0-28. Higher score indicates more insomnia.
Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Self-reported participant satisfaction
Time Frame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
The Client Satisfaction Questionnaire (CSQ-8). 8 items: answer format range 1-4; total score range: 8-32. Higher score indicates better satisfaction.
Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Carer-reported participant satisfaction
Time Frame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
The Client Satisfaction Questionnaire (CSQ-8). 8 items: answer format range 1-4; total score range: 8-32. Higher score indicates better satisfaction.
Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Self-reported participant satisfaction
Time Frame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
The Client Satisfaction Questionnaire (CSQ-8). 8 items: answer format range 1-4; total score range: 8-32. Higher score indicates better satisfaction.
Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Carer-reported participant satisfaction
Time Frame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
The Client Satisfaction Questionnaire (CSQ-8). 8 items: answer format range 1-4; total score range: 8-32. Higher score indicates better satisfaction.
Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Self-reported participant motivation
Time Frame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
The 7-item interest/enjoyment subscale of the Intrinsic Motivation Inventory (IMI). 7 items: answer format range 1-7; total score range: 1-7. Higher score indicates more motivation.
Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Carer-reported participant motivation
Time Frame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
The 7-item interest/enjoyment subscale of the Intrinsic Motivation Inventory (IMI). 7 items: answer format range 1-7; total score range: 1-7. Higher score indicates more motivation.
Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Self-reported participant motivation
Time Frame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
The 7-item interest/enjoyment subscale of the Intrinsic Motivation Inventory (IMI). 7 items: answer format range 1-7; total score range: 1-7. Higher score indicates more motivation.
Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Carer-reported participant motivation
Time Frame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
The 7-item interest/enjoyment subscale of the Intrinsic Motivation Inventory (IMI). 7 items: answer format range 1-7; total score range: 1-7. Higher score indicates more motivation.
Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative Interviews
Time Frame: 8 weeks after post-intervention (approximately 16 weeks after Baseline assessment (T1): Follow-up, T4)
Following the T4 assessment, participants included in the intervention arm will be invited to participate in a 30-minutes semi-structured, audio recorded interview.
8 weeks after post-intervention (approximately 16 weeks after Baseline assessment (T1): Follow-up, T4)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Collaborators

University of Aarhus

Investigators

  • Principal Investigator: Lisa M Wu, PhD, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

June 24, 2025

Study Completion (Actual)

June 24, 2025

Study Registration Dates

First Submitted

May 1, 2023

First Submitted That Met QC Criteria

May 11, 2023

First Posted (Actual)

May 15, 2023

Study Record Updates

Last Update Posted (Estimated)

October 3, 2025

Last Update Submitted That Met QC Criteria

September 30, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ImPACT Adult

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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