Clinical trial NCT05858359: Contextualized Neuropsychological Rehabilitation for CNS Cancer Survivors: The ImPACT Program
Official title: Contextualized Neuropsychological Rehabilitation for CNS Cancer Survivors: The "I'm Aware: Patients and Carers Together" (ImPACT) Program"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Cancer
Cognitive Impairment
Keywords: Brain Cancer
Brain Tumor
Cognitive Impairment
Neurobehavioral Impairment
Neuropsychological Rehabilitation
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
First posted: 2023-05-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized waitlist controlled trial
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Self-reported cognitive functioning
timeFrame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
measure: Carer-reported cognitive functioning
timeFrame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
measure: Self-reported neurobehavioral functioning
timeFrame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
measure: Carer-reported neurobehavioral functioning
timeFrame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Secondary outcomes:
measure: Self-reported cognitive functioning
timeFrame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
measure: Carer-reported cognitive functioning
timeFrame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
measure: Self-reported neurobehavioral functioning
timeFrame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
measure: Carer-reported neurobehavioral functioning
timeFrame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
measure: Objective cognitive functioning (Neuropsychological tests; Patient only)
timeFrame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
measure: Objective cognitive functioning (Neuropsychological tests; Patient only)
timeFrame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
measure: Premorbid intellectual functioning (Patient only)
timeFrame: Baseline (T1)
measure: Self-reported fatigue
timeFrame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
measure: Carer-reported fatigue
timeFrame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
measure: Self-reported fatigue
timeFrame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
measure: Carer-reported fatigue
timeFrame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
measure: Self-reported mental fatigue
timeFrame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
measure: Carer-reported mental fatigue
timeFrame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
measure: Self-reported mental fatigue
timeFrame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
measure: Carer-reported mental fatigue
timeFrame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
measure: Depression (patient only)
timeFrame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
measure: Depression (patient only)
timeFrame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
measure: Self-reported health-related quality of life
timeFrame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
measure: Carer-reported health-related quality of life
timeFrame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
measure: Self-reported health-related quality of life
timeFrame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
measure: Carer-reported health-related quality of life
timeFrame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
measure: Self-reported community integration
timeFrame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
measure: Carer-reported community integration
timeFrame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
measure: Self-reported community integration
timeFrame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
measure: Carer-reported community integration
timeFrame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
measure: Insomnia
timeFrame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
measure: Insomnia
timeFrame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
measure: Self-reported participant satisfaction
timeFrame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
measure: Carer-reported participant satisfaction
timeFrame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
measure: Self-reported participant satisfaction
timeFrame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
measure: Carer-reported participant satisfaction
timeFrame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
measure: Self-reported participant motivation
timeFrame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
measure: Carer-reported participant motivation
timeFrame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
measure: Self-reported participant motivation
timeFrame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
measure: Carer-reported participant motivation
timeFrame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Other outcomes:
measure: Qualitative Interviews
timeFrame: 8 weeks after post-intervention (approximately 16 weeks after Baseline assessment (T1): Follow-up, T4)
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Lisa M Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References: