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Completed

NCT Number: NCT05858359

Contextualized Neuropsychological Rehabilitation for CNS Cancer Survivors: The 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.

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Key information

Conditions

Brain Cancer Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Cognition Disorders Cognitive Dysfunction Cognitive Impairment Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurocognitive Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, 8270, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ImPACT program

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Self-reported cognitive functioning

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

    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.

  2. Carer-reported cognitive functioning

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

    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.

  3. Self-reported neurobehavioral functioning

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

    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.

  4. Carer-reported neurobehavioral functioning

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

    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.

  5. Objective cognitive functioning (Neuropsychological tests; Patient only)

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

    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.

  6. Objective cognitive functioning (Neuropsychological tests; Patient only)

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

    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.

  7. Premorbid intellectual functioning (Patient only)

    Time frame: Baseline (T1)

    WAIS-IV Information subtest. 26 items; answer format range 0-1; total score range: 0-26. Higher score indicates higher premorbid intellectual functioning.

  8. Self-reported fatigue

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

    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.

  9. Carer-reported fatigue

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

    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.

  10. Self-reported fatigue

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

    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.

  11. Carer-reported fatigue

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

    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.

  12. Self-reported mental fatigue

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

    The Mental Fatigue Scale (MFS). 15 items: answer format range 0-3; total score range: 0-45. Higher score indicates more mental fatigue.

  13. Carer-reported mental fatigue

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

    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.

  14. Self-reported mental fatigue

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

    The Mental Fatigue Scale (MFS). 15 items: answer format range 0-3; total score range: 0-45. Higher score indicates more mental fatigue.

  15. Carer-reported mental fatigue

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

    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.

  16. Depression (patient only)

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

    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.

  17. Depression (patient only)

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

    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.

  18. Self-reported health-related quality of life

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

    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.

  19. Carer-reported health-related quality of life

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

    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.

  20. Self-reported health-related quality of life

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

    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.

  21. Carer-reported health-related quality of life

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

    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.

  22. Self-reported community integration

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

    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.

  23. Carer-reported community integration

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

    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.

  24. Self-reported community integration

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

    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.

  25. Carer-reported community integration

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

    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.

  26. Insomnia

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

    The Insomnia Severity Index (ISI). 7 items; answer format range: 0-4; total score range: 0-28. Higher score indicates more insomnia.

  27. Insomnia

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

    The Insomnia Severity Index (ISI). 7 items; answer format range: 0-4; total score range: 0-28. Higher score indicates more insomnia.

  28. Self-reported participant satisfaction

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

    The Client Satisfaction Questionnaire (CSQ-8). 8 items: answer format range 1-4; total score range: 8-32. Higher score indicates better satisfaction.

  29. Carer-reported participant satisfaction

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

    The Client Satisfaction Questionnaire (CSQ-8). 8 items: answer format range 1-4; total score range: 8-32. Higher score indicates better satisfaction.

  30. Self-reported participant satisfaction

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

    The Client Satisfaction Questionnaire (CSQ-8). 8 items: answer format range 1-4; total score range: 8-32. Higher score indicates better satisfaction.

  31. Carer-reported participant satisfaction

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

    The Client Satisfaction Questionnaire (CSQ-8). 8 items: answer format range 1-4; total score range: 8-32. Higher score indicates better satisfaction.

  32. Self-reported participant motivation

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

    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.

  33. Carer-reported participant motivation

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

    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.

  34. Self-reported participant motivation

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

    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.

  35. Carer-reported participant motivation

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

    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.

Other outcomes

  1. Qualitative Interviews

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

    Following the T4 assessment, participants included in the intervention arm will be invited to participate in a 30-minutes semi-structured, audio recorded interview.

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • University of Aarhus

Registry information

Official study title

Contextualized Neuropsychological Rehabilitation for CNS Cancer Survivors: The "I'm Aware: Patients and Carers Together" (ImPACT) Program"

Acronym: ImPACT

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 15, 2023
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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