En online forskningsundersøgelse: BrainHealth in Breast Cancer Survivors
BrainHealth hos brystkræftoverlevere
This study will investigate the benefits of distinct brain health trainings in breast cancer survivors (age 30-80) with cognitive concerns post-chemotherapy. This study can be completed from the comfort of participant's own home.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Participants will complete online assessments at 3 timepoints over 6 months (Month 0, 3, 6). During the first 3 months of the study, participants will be randomized into one of three online training programs to support cognitive function; training will end after the first 3 months. The third online assessment (Month 6) will measure maintained gains since ending training. Participants will not be aware of the interventions assigned to other participants. Participants may be reimbursed for their time.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Texas
-
Dallas, Texas, Forenede Stater, 75235
- The Center for BrainHealth at the University of Texas at Dallas
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Female breast cancer survivors who...
- are between ages of 30-80
- were diagnosed with Stage I-III
- received chemotherapy
- completed chemotherapy at least 6 months ago but not more than 5 years
- endorse changes in thinking since end of chemotherapy treatment
- have working internet and a device
- consider themselves fluent in English
Exclusion criteria:
- Males
- A re-occurrence of breast cancer or a diagnosis of another
- An uncorrected hearing or vision issue that would hinder ability to read and/or listen to training material
- Participation in a cognitive training program in the last 12 months.
- A reported substance abuse problem
- Diagnosis of a neurodegenerative disease or psychotic disorder
- History of stroke, concussion, or brain injury since completing chemotherapy
- Inability to function independently due to Autism Spectrum Disorder diagnosis
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Brain Training A
This group will access one type of online brain-health oriented training. |
Interventions may include education, exercises, and/or strategies to support brain health |
|
Aktiv komparator: Brain Training B
This group will access a distinct type of online brain-health oriented training. |
Interventions may include education, exercises, and/or strategies to support brain health |
|
Aktiv komparator: Brain Training C
This group will access a distinct type of online brain-health oriented training. |
Interventions may include education, exercises, and/or strategies to support brain health |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
BrainHealth Index (composite and factor) scores
Tidsramme: Baseline, 3 month, 6 month
|
The investigators will assess change on a holistic measure of cognitive, social, well-being, and daily life health on the BrainHealth Index across multiple timepoints. (Min value = 16, Max value = 1032) (Higher score = Better outcome) |
Baseline, 3 month, 6 month
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Functional Assessment of Cancer Therapy - Cognitive Function (FACT_Cog)
Tidsramme: Baseline, 3 month, 6 month
|
The investigators will assess change in self-reported cognitive deficits following an online training program. (Min value = 0, Max value = 148) (Higher score = better outcome) |
Baseline, 3 month, 6 month
|
|
Double Decision
Tidsramme: Baseline, 3 month, 6 month
|
The investigators will assess change scores on a visual processing speed task (Min value = 0, Max value = 100) (Higher score = Better performance) |
Baseline, 3 month, 6 month
|
|
Rapid Visual Information Processing
Tidsramme: Baseline, 3 month, 6 month
|
The investigators will assess change scores on measure of selective attention (Min value = 0, Max value = 100) (Higher score = Better performance) |
Baseline, 3 month, 6 month
|
|
Delayed matching to sample
Tidsramme: Baseline, 3 month, 6 month
|
The investigators will assess change scores on measure of visual memory (Min value = 0, Max value = 100) (Higher score = Better performance) |
Baseline, 3 month, 6 month
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Sandra B Chapman, PhD, Center for BrainHealth
Publikationer og nyttige links
Generelle publikationer
- Chapman SB, Aslan S, Spence JS, Hart JJ Jr, Bartz EK, Didehbani N, Keebler MW, Gardner CM, Strain JF, DeFina LF, Lu H. Neural mechanisms of brain plasticity with complex cognitive training in healthy seniors. Cereb Cortex. 2015 Feb;25(2):396-405. doi: 10.1093/cercor/bht234. Epub 2013 Aug 28.
- Chapman SB, Mudar RA. Enhancement of cognitive and neural functions through complex reasoning training: evidence from normal and clinical populations. Front Syst Neurosci. 2014 Apr 28;8:69. doi: 10.3389/fnsys.2014.00069. eCollection 2014.
- Chapman SB, Fratantoni JM, Robertson IH, D'Esposito M, Ling GSF, Zientz J, Vernon S, Venza E, Cook LG, Tate A, Spence JS. A Novel BrainHealth Index Prototype Improved by Telehealth-Delivered Training During COVID-19. Front Public Health. 2021 Mar 16;9:641754. doi: 10.3389/fpubh.2021.641754. eCollection 2021.
- Chapman SB, Aslan S, Spence JS, Keebler MW, DeFina LF, Didehbani N, Perez AM, Lu H, D'Esposito M. Distinct Brain and Behavioral Benefits from Cognitive vs. Physical Training: A Randomized Trial in Aging Adults. Front Hum Neurosci. 2016 Jul 18;10:338. doi: 10.3389/fnhum.2016.00338. eCollection 2016.
- Chapman SB, Spence JS, Aslan S, Keebler MW. Enhancing Innovation and Underlying Neural Mechanisms Via Cognitive Training in Healthy Older Adults. Front Aging Neurosci. 2017 Oct 9;9:314. doi: 10.3389/fnagi.2017.00314. eCollection 2017.
- Motes MA, Yezhuvath US, Aslan S, Spence JS, Rypma B, Chapman SB. Higher-order cognitive training effects on processing speed-related neural activity: a randomized trial. Neurobiol Aging. 2018 Feb;62:72-81. doi: 10.1016/j.neurobiolaging.2017.10.003. Epub 2017 Oct 12.
- Han K, Davis RA, Chapman SB, Krawczyk DC. Strategy-based reasoning training modulates cortical thickness and resting-state functional connectivity in adults with chronic traumatic brain injury. Brain Behav. 2017 Apr 10;7(5):e00687. doi: 10.1002/brb3.687. eCollection 2017 May.
- Vas A, Chapman S, Aslan S, Spence J, Keebler M, Rodriguez-Larrain G, Rodgers B, Jantz T, Martinez D, Rakic J, Krawczyk D. Reasoning training in veteran and civilian traumatic brain injury with persistent mild impairment. Neuropsychol Rehabil. 2016 Aug;26(4):502-31. doi: 10.1080/09602011.2015.1044013. Epub 2015 May 27.
- Das N, Spence JS, Aslan S, Vanneste S, Mudar R, Rackley A, Quiceno M, Chapman SB. Cognitive Training and Transcranial Direct Current Stimulation in Mild Cognitive Impairment: A Randomized Pilot Trial. Front Neurosci. 2019 Apr 12;13:307. doi: 10.3389/fnins.2019.00307. eCollection 2019.
- Han K, Martinez D, Chapman SB, Krawczyk DC. Neural correlates of reduced depressive symptoms following cognitive training for chronic traumatic brain injury. Hum Brain Mapp. 2018 Jul;39(7):2955-2971. doi: 10.1002/hbm.24052. Epub 2018 Mar 23.
- Venza EE, Chapman SB, Aslan S, Zientz JE, Tyler DL, Spence JS. Enhancing Executive Function and Neural Health in Bipolar Disorder through Reasoning Training. Front Psychol. 2016 Nov 1;7:1676. doi: 10.3389/fpsyg.2016.01676. eCollection 2016.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 24-434
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .