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Trial Title:
Contextualized Neuropsychological Rehabilitation for CNS Cancer Survivors: The ImPACT Program
NCT ID:
NCT05858359
Condition:
Brain Cancer
Cognitive Impairment
Conditions: Official terms:
Brain Neoplasms
Cognitive Dysfunction
Conditions: Keywords:
Brain Cancer
Brain Tumor
Cognitive Impairment
Neurobehavioral Impairment
Neuropsychological Rehabilitation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomized waitlist controlled trial
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
ImPACT program
Description:
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.
Arm group label:
ImPACT program
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Aarhus University Hospital
Address:
City:
Aarhus
Zip:
8270
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Cecilie DR Buskbjerg, Ph.D.
Phone:
29842526
Phone ext:
45
Email:
cdrc@psy.au.dk
Contact backup:
Last name:
Lisa Wu, Ph.D.
Start date:
June 1, 2023
Completion date:
June 1, 2026
Lead sponsor:
Agency:
Aarhus University Hospital
Agency class:
Other
Collaborator:
Agency:
University of Aarhus
Agency class:
Other
Source:
Aarhus University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05858359
