Contextualized Neuropsychological Rehabilitation for CNS Cancer Survivors: The ImPACT Program

Aarhus University Hospital

Status: Completed

Conditions: Cognitive Impairment; Brain Cancer

Treatments: Behavioral: ImPACT program

Study type: Interventional

Funder types: Other

Identifiers

NCT05858359

ImPACT Adult

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

ImPACT program

Experimental group

Description:

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

Treatment:

Behavioral: ImPACT program

Waitlist

No Intervention group

Description:

Waitlist control