Contextualized Neuropsychological Rehabilitation for CNS Cancer Survivors: The ImPACT Program

NCT05858359 | Completed

• 1 other identifier: ImPACT Adult
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Cancer; Cognitive Impairment

Keywords

Brain Cancer; Brain Tumor; Cognitive Impairment; Neurobehavioral Impairment; Neuropsychological Rehabilitation

Outcome Measures

Primary Outcomes (4)

• Self-reported cognitive functioning

  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

  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

  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

  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 Outcomes (35)

• Self-reported cognitive functioning

  Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]

• Carer-reported cognitive functioning

  Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]

• Self-reported neurobehavioral functioning

  Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]

• Carer-reported neurobehavioral functioning

  Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]

• Objective cognitive functioning (Neuropsychological tests; Patient only)

  Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)

Other Outcomes (1)

• Qualitative Interviews

  8 weeks after post-intervention (approximately 16 weeks after Baseline assessment (T1): Follow-up, T4)

Study Arms (2)

ImPACT program

EXPERIMENTAL

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

Behavioral: ImPACT program

Waitlist

NO INTERVENTION

Waitlist control

Interventions

ImPACT program 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.

ImPACT program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Aarhus University Hospital: lead
• University of Aarhus: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, 8270, Denmark

Location

MeSH Terms

Conditions

Brain Neoplasms; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Lisa M Wu, PhD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized waitlist controlled trial

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 15, 2023
• Study Start: June 1, 2023
• Primary Completion: June 24, 2025
• Study Completion: June 24, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)