Clinical trial NCT06553235: RESET-BRAIN: REhabilitation of SleEp and CogniTive Impairment in BReast Cancer Survivors Using an App-based Intervention
Official title: RESET-BRAIN: REhabilitation of SleEp and CogniTive Impairment in BReast Cancer Survivors Using an App-based Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Cognitive Impairment
Breast Cancer
Keywords: Cognitive behavioral therapy for insomnia
CBT-I
Breast cancer
Insomnia
Sleep
Cognitive function
Magnetic resonance imaging
White matter
Gray matter
Glymphatic function
Diffusion tensor image along the perivascular space
Structural brain networks
Inflammation
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
First posted: 2024-08-14
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of the study is to investigate whether treating insomnia using app-based cognitive behavioral therapy for insomnia (CBT-I) can improve cognitive impairment in breast cancer survivors compared to an active control group (sleep hygiene education). The study will also explore if CBT-I is associated with changes in the brain and in inflammation. The investigators will recruit approximately 84 participants with insomnia and cognitive impairment who have completed breast cancer treatment within 1-5 years.

Detailed description: The study is a randomized controlled trial comparing the effect of app-based cognitive behavioral therapy for insomnia (CBT-I) on cognitive function and insomnia to an active control group (sleep hygiene). Participants will be 84 breast cancer survivors who have completed primary treatment within 1-5 years and experience insomnia and cognitive impairment. After baseline assessment, participants will be randomized to either app-based CBT-I or sleep hygiene (active control). Both groups will undergo post-treatment assessments and 6-months follow-up assessments. The primary outcomes will be cognitive impairment assessed with the Conners Continuous Performance Test (CCPT) and insomnia assessed with the Insomnia Severity Index (ISI). To explore potential neurobiological and inflammatory mechanisms, structural magnetic resonance imaging (MRI) and inflammatory markers will be secondary outcomes. To provide a broader insight into cognitive function, participants will undergo further neuropsychological assessment with various standardized neuropsychological tests.

The study has the following aims and hypotheses:

PRIMARY AIM: To investigate whether an app-based CBT-I is associated with improved sleep and cognitive function in BC survivors screened for insomnia and CI when compared with an active control group. PRIMARY HYPOTHESIS: Compared with an active control group, CBT-I will be associated with a statistically significantly greater reduction in insomnia severity using the ISI and improvement of sustained attention and executive function assessed objectively using the CCPT. Effects on secondary sleep outcomes will also be tested. Exploratory hypothesis: Improvements in sustained attention and executive function will be mediated by improved insomnia severity and sleep outcomes.

SECONDARY AIM 1: To investigate whether CBT-I is associated with altered structural brain outcomes when compared with an active control group. HYPOTHESIS: Compared with an active control group, CBT-I will be associated with changes in brain gray and white matter properties, structural network topology, as well as glymphatic function as operationalized with the diffusion tensor image along the perivascular space (DTI-ALPS) approach.

SECONDARY AIM 2: To explore whether CBT-I is associated with changes in inflammatory immune function (IL-1β, IL-6, TNF-α, IFN-γ) when compared with an active control group. HYPOTHESIS: Compared with an active control group, CBT-I will be associated with a statistically significantly greater reduction in inflammatory markers. Improvements in sustained attention and executive function will be mediated by changes in inflammatory markers.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Have completed primary breast cancer (BC) treatment within 1-5 years (endocrine therapies allowed)
* Insomnia: a score of \>10 on the Insomnia Severity index (ISI) and/or meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for Insomnia Disorder
* Cognitive impairment: a score of "quite a bit" or "very much" on at least 1 of the 2 items measuring concentration and memory on The European Organization for Research and Treatment of Cancer Core Quality of Life (EORCT-QLQ-C30) and/or \<54 on the Cancer Therapy-Cognitive (FACT-Cog) perceived cognitive impairment (PCI) subscale

Exclusion Criteria:

* Other sleep disorders than insomnia that may confound sleep and/or cognitive function
* Use of drugs impacting that may confound sleep and/or cognitive function (endocrine therapies allowed)
* Neurodegenerative and psychiatric disorders that may confound sleep and/or cognitive function
* Shift work
* Pregnancy or maternity leave
* Recurrence of BC or new cancer
* Insufficient Danish proficiency
* Substance abuse that may confound sleep and/or cognitive function
* Previous experience with CBT-I
* Other cancer than breast cancer

Primary outcomes:
measure: Conners continuous performance test 3rd edition
timeFrame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Secondary outcomes:
measure: Psychomotor Vigilance Test (PVT)
timeFrame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
measure: Trail-Making Test Part A (TMT-A)
timeFrame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
measure: Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) - Coding
timeFrame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
measure: Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) - Digit span
timeFrame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
measure: Paced Auditory Serial Addition Test (PASAT)
timeFrame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
measure: Hopkins Verbal Learning Test-Revised (HVLT-R)
timeFrame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
measure: Brief Visuospatial Memory Test-Revised (BVMT-R)
timeFrame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
measure: Controlled Oral Word Association Test (COWAT)
timeFrame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
measure: Trail-Making Test Part B (TMT-B)
timeFrame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
measure: Stroop Color and Word Test
timeFrame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
measure: Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) - Information
timeFrame: Baseline (week 0)
measure: Glymphatic function
timeFrame: Baseline (week 0), 6-months follow-up (approximately week 33)
measure: Structural brain networks
timeFrame: Baseline (week 0), 6-months follow-up (approximately week 33)
measure: Brain gray matter
timeFrame: Baseline (week 0), 6-months follow-up (approximately week 33)
measure: Brain white matter
timeFrame: Baseline (week 0), 6-months follow-up (approximately week 33)
measure: Brain white matter microstructure
timeFrame: Baseline (week 0), 6-months follow-up (approximately week 33)
measure: Tumor necrosis factor alpha (TNF-α)
timeFrame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
measure: Interleukin 1 beta (Il-1β)
timeFrame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
measure: Interleukin 6 (IL-6)
timeFrame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
measure: Interferon gamma (IFN-γ)
timeFrame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
measure: High sensitivity C-reactive protein (hsCRP)
timeFrame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
measure: Objective sleep
timeFrame: Baseline (week 0), post-treatment (approximately week 9)
measure: Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog)
timeFrame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
measure: Patient Assessment of Own Functioning Inventory (PAOFI)
timeFrame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
measure: The European Organization for Research and Treatment of Cancer Core Quality of Life (EORCT-QLQ-C30)
timeFrame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
measure: Morningness-Eveningness Questionnaire-reduced (MEQr)
timeFrame: Baseline (week 0)
measure: The Functional Assessment of Chronic Illness Therapy (FACIT Fatigue) scale
timeFrame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
measure: The perceived stress scale (PSS)
timeFrame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
measure: The numeric rating scale (NRS)
timeFrame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
measure: Brief Pain Inventory (pain interference (subscale))
timeFrame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
measure: The Short-Form (36) Health Survey (SF -36)
timeFrame: Baseline (week 0)
measure: Charlson Comorbidity Index (CCI)
timeFrame: Baseline (week 0)
measure: Expectancy/Credibility Questionnaire (CEQ)
timeFrame: Baseline (week 0)
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
Study officials:
References: