Contextualized Neuropsychological Rehabilitation for CNS Cancer Survivors: The ImPACT Program

Cognitive Impairment Clinical Trial

— ImPACT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05858359
• Other study ID #: ImPACT Adult
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: June 1, 2026

Study information

• Verified date: July 2023
• Source: Aarhus University Hospital
• Contact: Lisa M Wu, PhD
• Phone: +45 87 15 37 48
• Email: lisa.wu[@]oncology.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Cancer
• Brain Neoplasms
• Cognitive Dysfunction
• Cognitive Impairment

Intervention

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.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
Aarhus University Hospital	University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Qualitative Interviews	Following the T4 assessment, participants included in the intervention arm will be invited to participate in a 30-minutes semi-structured, audio recorded interview.	8 weeks after post-intervention (approximately 16 weeks after Baseline assessment (T1): Follow-up, T4)
Primary	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.	Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Primary	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.	Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Primary	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.	Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Primary	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.	Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Secondary	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.	Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Secondary	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.	Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Secondary	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.	Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Secondary	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.	Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Secondary	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.	Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Secondary	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.	Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Secondary	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.	Baseline (T1)
Secondary	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.	Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Secondary	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.	Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Secondary	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.	Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Secondary	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.	Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Secondary	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.	Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Secondary	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.	Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Secondary	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.	Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Secondary	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.	Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Secondary	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.	Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Secondary	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.	Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Secondary	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.	Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Secondary	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.	Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Secondary	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.	Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Secondary	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.	Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Secondary	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.	Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Secondary	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.	Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Secondary	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.	Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Secondary	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.	Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Secondary	Insomnia	The Insomnia Severity Index (ISI). 7 items; answer format range: 0-4; total score range: 0-28. Higher score indicates more insomnia.	Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Secondary	Insomnia	The Insomnia Severity Index (ISI). 7 items; answer format range: 0-4; total score range: 0-28. Higher score indicates more insomnia.	Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Secondary	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.	Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Secondary	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.	Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Secondary	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.	Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Secondary	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.	Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Secondary	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.	Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Secondary	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.	Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
Secondary	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.	Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Secondary	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.	Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]