Contextualized Neuropsychological Rehabilitation for CNS Cancer Survivors: The ImPACT Program

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05858359
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Aarhus University Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Lisa M Wu, PhD
Principal Investigator Affiliation	Aarhus University Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Denmark
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Cancer, Cognitive Impairment

Additional Details

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.

Arms & Interventions

Arms

Experimental: ImPACT program

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

No Intervention: Waitlist

Waitlist control

Interventions

Behavioral: - ImPACT program

During the ImPACT program, the brain cancer survivor and a carer collaborate on: Becoming aware of the patient's core strengths and difficulties Helping the patient to be optimally responsive to the guidance of the carer, and Creating compensatory strategies to respond to real-world manifestations of the patient's difficulties and helping the patient implement these strategies at home.

Contact a Trial Team

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