Clinical trial NCT06545045: Cognitive Rehabilitation Following Breast Cancer Treatment
Official title: Pilot Testing of Metacognitive Strategy Training to Address Cancer-related Cognitive Impairment in Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Female
Keywords: Cancer
Breast Cancer
Cognition
Metacognition
Activities of daily living
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2024-08-09
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this proposed project is to evaluate the feasibility and preliminary effect of metacognitive strategy training to improve activity performance, cognition, and quality of life in breast cancer survivors with cancer-related cognitive impairment (CRCI). The other goal of this proposed project is to examine the effects of CO-OP on resting (rsFC)- and task-state functional connectivity as compared to an inactive control group.

Detailed description: Breast cancer survivors often self-report cognitive deficits, primarily in executive functioning (planning, problem solving, multitasking), memory, and processing speed after cancer treatment, i.e., cancer-related cognitive impairment (CRCI). The prevalence of CRCI following breast cancer is as high as 78% and can persist chronically after treatment has ended. In other health conditions associated with cognitive impairment, such as traumatic brain injury, the only evidence-based recommended practice standard for deficits in executive function is metacognitive strategy training (MCST). In this approach, participants are taught a general cognitive strategy that can be applied in known and novel contexts to devise task specific strategies to successfully engage in an activity. While the cognitive deficits identified in and described by breast cancer survivors seem quite amenable to MCST, there is no study in the published literature which measures the efficacy of MCST on CRCI. The Cognitive Orientation to daily Occupational Performance (CO-OP) approach is a MCST intervention in which subjects are taught a general cognitive strategy that can be applied in known and novel contexts to devise task specific strategies to engage in an activity. Preliminary data suggest that CO-OP may have a positive impact on subjective and objective cognitive performance in breast cancer survivors with CRCI. Further, this study will evaluate the neurophysiological underpinnings associated with treatment changes through the use of neuroimaging methods.

Eligibility criteria: Inclusion Criteria:

* self-reported CRCI (Global Rating of Cognition dysfunction as "Moderately" "Strongly "or "Extremely" AND a Cognitive Failures Questionnaire1 (CFQ) score \>30)
* completed treatment for active cancer diagnosis (invasive ductal or lobular BrCA Stages I, II, or III) at least 6 months but not greater than 3 years prior to participation
* able to read, write, and speak English fluently
* able to provide valid informed consent
* have a life expectancy of greater than 6 months at time of enrollment
* on stable doses (i.e., no changes in past 90 days) of medications that are known to impact cognitive function (i.e., anti-depressants)

Exclusion Criteria:

* prior cancer diagnoses of other sites with evidence of active disease within the past year
* active diagnoses of any acute or chronic brain-related neurological conditions that can alter normal brain anatomy or function (e.g., Parkinson's disease, dementia, cerebral infarcts) dementia symptoms as indicated by a score of \<23 on the Montreal Cognitive Assessment (MoCA)
* severe depressive symptoms (Personal Health Questionnaire-9 (PHQ-9) score of ≥21)
* history of severe traumatic brain injury, prolonged loss of consciousness (e.g., coma)
* conditions contraindicated for MRI (e.g., electrical implants, pumps, claustrophobia)
* blue-yellow colorblindness
* pregnancy

The screening methods identified in parentheses next to appropriate inclusion/exclusion criteria will be used to verify appropriate selection of study participants.

Primary outcomes:
measure: Feasibility measures
timeFrame: After study completion, an average of 12 weeks
measure: Canadian Occupational Performance Measure (COPM) Performance
timeFrame: Pre-intervention (week 0) and post-intervention (week 12)
measure: Canadian Occupational Performance Measure (COPM) Satisfaction
timeFrame: Pre-intervention (week 0) and post-intervention (week 12)
Secondary outcomes:
measure: Cognitive Failures Questionnaire (CFQ)
timeFrame: Pre-intervention (week 0) and post-intervention (week 12)
measure: Dysexecutive Questionnaire (DEX)
timeFrame: Pre-intervention (week 0) and post-intervention (week 12)
measure: Trail Making Test (TMT)
timeFrame: Pre-intervention (week 0) and post-intervention (week 12)
measure: Controlled Oral Word Association (COWA)
timeFrame: Pre-intervention (week 0) and post-intervention (week 12)
measure: The Activity Card Sort (ACS)
timeFrame: Pre-intervention (week 0) and post-intervention (week 12)
measure: Functional Assessment of Cancer Therapy-Breast (FACT-B)
timeFrame: Pre-intervention (week 0) and post-intervention (week 12)
measure: Participation Strategies Self Efficacy Scale (PS-SES)
timeFrame: Pre-intervention (week 0) and post-intervention (week 12)
measure: Paced Auditory Serial Addition Test (PASAT)
timeFrame: Pre-intervention (week 0) and post-intervention (week 12)
measure: Hopkins Verbal Learning Test-Revised (HVLT-R)
timeFrame: Pre-intervention (week 0) and post-intervention (week 12)
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri Occupational Therapy
name: Anna E Boone, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hutchinson AD, Hosking JR, Kichenadasse G, Mattiske JK, Wilson C. Objective and subjective cognitive impairment following chemotherapy for cancer: a systematic review. Cancer Treat Rev. 2012 Nov;38(7):926-34. doi: 10.1016/j.ctrv.2012.05.002. Epub 2012 Jun 2.
citation: O'Farrell E, MacKenzie J, Collins B. Clearing the air: a review of our current understanding of "chemo fog". Curr Oncol Rep. 2013 Jun;15(3):260-9. doi: 10.1007/s11912-013-0307-7.
citation: Schagen SB, Wefel JS. Chemotherapy-related changes in cognitive functioning. EJC Suppl. 2013 Sep;11(2):225-32. doi: 10.1016/j.ejcsup.2013.07.007. No abstract available.
citation: Myers JS. Chemotherapy-related cognitive impairment. Clin J Oncol Nurs. 2009 Aug;13(4):413-21. doi: 10.1188/09.CJON.413-421.
citation: Janelsins MC, Kohli S, Mohile SG, Usuki K, Ahles TA, Morrow GR. An update on cancer- and chemotherapy-related cognitive dysfunction: current status. Semin Oncol. 2011 Jun;38(3):431-8. doi: 10.1053/j.seminoncol.2011.03.014.
citation: Wefel JS, Schagen SB. Chemotherapy-related cognitive dysfunction. Curr Neurol Neurosci Rep. 2012 Jun;12(3):267-75. doi: 10.1007/s11910-012-0264-9.
citation: Janelsins MC, Kesler SR, Ahles TA, Morrow GR. Prevalence, mechanisms, and management of cancer-related cognitive impairment. Int Rev Psychiatry. 2014 Feb;26(1):102-13. doi: 10.3109/09540261.2013.864260.
citation: Cicerone KD, Dahlberg C, Kalmar K, Langenbahn DM, Malec JF, Bergquist TF, Felicetti T, Giacino JT, Harley JP, Harrington DE, Herzog J, Kneipp S, Laatsch L, Morse PA. Evidence-based cognitive rehabilitation: recommendations for clinical practice. Arch Phys Med Rehabil. 2000 Dec;81(12):1596-615. doi: 10.1053/apmr.2000.19240.
citation: Cicerone KD, Langenbahn DM, Braden C, Malec JF, Kalmar K, Fraas M, Felicetti T, Laatsch L, Harley JP, Bergquist T, Azulay J, Cantor J, Ashman T. Evidence-based cognitive rehabilitation: updated review of the literature from 2003 through 2008. Arch Phys Med Rehabil. 2011 Apr;92(4):519-30. doi: 10.1016/j.apmr.2010.11.015.
citation: Haskins E. Cognitive Rehabilitation Manual: Translating Evidence-Based Recommendations into Practice. vol 1. American Congress of Rehabilitation Medicine; 2012.
citation: Wolf TJ, Doherty M, Kallogjeri D, Coalson RS, Nicklaus J, Ma CX, Schlaggar BL, Piccirillo J. The Feasibility of Using Metacognitive Strategy Training to Improve Cognitive Performance and Neural Connectivity in Women with Chemotherapy-Induced Cognitive Impairment. Oncology. 2016;91(3):143-52. doi: 10.1159/000447744. Epub 2016 Jul 23.