Brain CancerImPACTNCT05858359
Contextualized Neuropsychological Rehabilitation for CNS Cancer Survivors: The ImPACT Program
A study testing ImPACT program in people with Brain Cancer and Cognitive Impairment, run by Aarhus University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Cancer, Cognitive Impairment
- What is being tested?
- ImPACT program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2023to 24 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Confounding diagnosed or suspected psychiatric or medical condition unrelated to the cancer or its treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Brain Cancer, Cognitive Impairment
- Being tested
- ImPACT program
- Keywords
- Brain Cancer, Brain Tumor, Cognitive Impairment, Neurobehavioral Impairment, Neuropsychological Rehabilitation
- Medical subject headings
- Brain Neoplasms, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImPACT programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ImPACT program | Experimental | The ImPACT program consists of 8 weekly 1-hour sessions with homework between sessions. Receives: Behavioral: ImPACT program |
| Waitlist | No intervention | Waitlist control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Secondary outcomes (35)
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.
Measured: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
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.
Measured: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
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.
Measured: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
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.
Measured: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Objective cognitive functioning (Neuropsychological tests; Patient only)
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.
Measured: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Objective cognitive functioning (Neuropsychological tests; Patient only)
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.
Measured: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Premorbid intellectual functioning (Patient only)
WAIS-IV Information subtest. 26 items; answer format range 0-1; total score range: 0-26. Higher score indicates higher premorbid intellectual functioning.
Measured: Baseline (T1)
Self-reported fatigue
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.
Measured: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Carer-reported fatigue
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.
Measured: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Self-reported fatigue
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.
Measured: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Carer-reported fatigue
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.
Measured: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Self-reported mental fatigue
The Mental Fatigue Scale (MFS). 15 items: answer format range 0-3; total score range: 0-45. Higher score indicates more mental fatigue.
Measured: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Carer-reported mental fatigue
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.
Measured: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Self-reported mental fatigue
The Mental Fatigue Scale (MFS). 15 items: answer format range 0-3; total score range: 0-45. Higher score indicates more mental fatigue.
Measured: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Carer-reported mental fatigue
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.
Measured: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Depression (patient only)
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.
Measured: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Depression (patient only)
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.
Measured: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Self-reported health-related quality of life
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.
Measured: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Carer-reported health-related quality of life
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.
Measured: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Self-reported health-related quality of life
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.
Measured: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Carer-reported health-related quality of life
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.
Measured: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Self-reported community integration
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.
Measured: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Carer-reported community integration
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.
Measured: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Self-reported community integration
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.
Measured: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Carer-reported community integration
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.
Measured: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Insomnia
The Insomnia Severity Index (ISI). 7 items; answer format range: 0-4; total score range: 0-28. Higher score indicates more insomnia.
Measured: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Insomnia
The Insomnia Severity Index (ISI). 7 items; answer format range: 0-4; total score range: 0-28. Higher score indicates more insomnia.
Measured: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Self-reported participant satisfaction
The Client Satisfaction Questionnaire (CSQ-8). 8 items: answer format range 1-4; total score range: 8-32. Higher score indicates better satisfaction.
Measured: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Carer-reported participant satisfaction
The Client Satisfaction Questionnaire (CSQ-8). 8 items: answer format range 1-4; total score range: 8-32. Higher score indicates better satisfaction.
Measured: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Self-reported participant satisfaction
The Client Satisfaction Questionnaire (CSQ-8). 8 items: answer format range 1-4; total score range: 8-32. Higher score indicates better satisfaction.
Measured: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Carer-reported participant satisfaction
The Client Satisfaction Questionnaire (CSQ-8). 8 items: answer format range 1-4; total score range: 8-32. Higher score indicates better satisfaction.
Measured: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Self-reported participant motivation
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.
Measured: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Carer-reported participant motivation
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.
Measured: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Self-reported participant motivation
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.
Measured: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Carer-reported participant motivation
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.
Measured: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start1 Jun 2023
- Primary completion24 Jun 2025
- Study completion24 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain CancerStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized waitlist controlled trial
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Principal investigator, Lisa Maria Wu, Aarhus University Hospital
- Investigators
- Lisa M Wu, PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858359
- Sponsor's protocol ID
- ImPACT Adult
- Acronym
- ImPACT
- Status last verified
- Sep 2025
- First submitted
- 1 May 2023
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contextualized Neuropsychological Rehabilitation for CNS Cancer Survivors: The "I'm Aware: Patients and Carers Together" (ImPACT) Program"
- ClinicalTrials.gov ID
- NCT05858359
- Acronym / sponsor ID
- ImPACT / ImPACT Adult
- Conditions
- Brain Cancer, Cognitive Impairment
- Keywords
- Brain Cancer, Brain Tumor, Cognitive Impairment, Neurobehavioral Impairment, Neuropsychological Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 24 Jun 2025 (actual)
- Study completion
- 24 Jun 2025 (actual)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized waitlist controlled trial
| Arm | Type | Receives |
|---|---|---|
| ImPACT program | Experimental | Behavioral: ImPACT programThe ImPACT program consists of 8 weekly 1-hour sessions with homework between sessions. |
| Waitlist | No intervention | –Waitlist control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Confounding diagnosed or suspected psychiatric or medical condition unrelated to the cancer or its treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImPACT programDuring 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. | Behavioural | ImPACT program |
Primary outcome
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.
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.
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.
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.
35 secondary outcomes
Self-reported cognitive functioning
Time frame: 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)]
Self-reported neurobehavioral functioning
Time frame: 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)]
Objective cognitive functioning (Neuropsychological tests; Patient only)
Time frame: 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)]
Premorbid intellectual functioning (Patient only)
Time frame: Baseline (T1)
Self-reported fatigue
Time frame: 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)
Self-reported fatigue
Time frame: 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)]
Self-reported mental fatigue
Time frame: 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)
Self-reported mental fatigue
Time frame: 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)]
Depression (patient only)
Time frame: 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)]
Self-reported health-related quality of life
Time frame: 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)
Self-reported health-related quality of life
Time frame: 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)]
Self-reported community integration
Time frame: 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)
Self-reported community integration
Time frame: 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)]
Insomnia
Time frame: 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)]
Self-reported participant satisfaction
Time frame: 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)
Self-reported participant satisfaction
Time frame: 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)]
Self-reported participant motivation
Time frame: 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)
Self-reported participant motivation
Time frame: 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)]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa M Wu, PhD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ImPACT program in people with Brain Cancer and Cognitive Impairment, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported cognitive functioning (time frame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.