Cognitive Rehabilitation Following Breast Cancer Treatment

Official title

Pilot Testing of Metacognitive Strategy Training to Address Cancer-related Cognitive Impairment in Breast Cancer

Overview

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.

Interventions

• Behavioral Metacognitive Strategy Training (MCST)
  The MCST group will follow procedures for the Cognitive Orientation to daily Occupational Performance intervention. First, five functional, everyday life goals are identified collaboratively by the participant and interventionist. In the second meeting, the therapist introduces the approach to the subject and teach a global cognitive strategy (i.e., GOAL-PLAN-DO-CHECK). In all subsequent sessions, this strategy is used as the main problem-solving framework to facilitate skill acquisition. The su
• Behavioral Inactive Control Group
  Weekly contact will be made via telephone call to (1) maintain study engagement, (2) introduce weekly social contact with researchers, mimicking some of the potential incidental effects of the experimental group, and (3) ascertain what, if any, additional steps participants have taken to reduce cognitive symptoms. The content of each of these meetings will be tracked in intervention notes.

Primary outcome measures

• Feasibility measures [Time frame: After study completion, an average of 12 weeks]
• Canadian Occupational Performance Measure (COPM) Performance [Time frame: Pre-intervention (week 0) and post-intervention (week 12)]
• Canadian Occupational Performance Measure (COPM) Satisfaction [Time frame: Pre-intervention (week 0) and post-intervention (week 12)]

Secondary outcome measures (9)

• Cognitive Failures Questionnaire (CFQ) [Time frame: Pre-intervention (week 0) and post-intervention (week 12)]
• Dysexecutive Questionnaire (DEX) [Time frame: Pre-intervention (week 0) and post-intervention (week 12)]
• Trail Making Test (TMT) [Time frame: Pre-intervention (week 0) and post-intervention (week 12)]
• Controlled Oral Word Association (COWA) [Time frame: Pre-intervention (week 0) and post-intervention (week 12)]
• The Activity Card Sort (ACS) [Time frame: Pre-intervention (week 0) and post-intervention (week 12)]
• Functional Assessment of Cancer Therapy-Breast (FACT-B) [Time frame: Pre-intervention (week 0) and post-intervention (week 12)]
• Participation Strategies Self Efficacy Scale (PS-SES) [Time frame: Pre-intervention (week 0) and post-intervention (week 12)]
• Paced Auditory Serial Addition Test (PASAT) [Time frame: Pre-intervention (week 0) and post-intervention (week 12)]
• Hopkins Verbal Learning Test-Revised (HVLT-R) [Time frame: Pre-intervention (week 0) and post-intervention (week 12)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Missouri — Columbia

Publications

• 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. PMID 22658913
• 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. PMID 23483375
• 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. PMID 26217131
• Myers JS. Chemotherapy-related cognitive impairment. Clin J Oncol Nurs. 2009 Aug;13(4):413-21. doi: 10.1188/09.CJON.413-421. PMID 19648097
• 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. PMID 21600374
• 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. PMID 22453825
• 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. PMID 24716504
• 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. PMID 11128897

Identifiers

NCT: NCT06545045 · 2101565 · 1R21CA286404

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗