Cognitive Rehabilitation Following Breast Cancer Treatment

NCT06545045 | Recruiting

• 2 other identifiers: 21015651R21CA286404
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female

Keywords

Cancer; Breast Cancer; Cognition; Metacognition; Activities of daily living

Outcome Measures

Primary Outcomes (3)

• Feasibility measures

  Recruitment rate, retention rate

  After study completion, an average of 12 weeks

• Canadian Occupational Performance Measure (COPM) Performance

  Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.

  Pre-intervention (week 0) and post-intervention (week 12)

• Canadian Occupational Performance Measure (COPM) Satisfaction

  Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.

  Pre-intervention (week 0) and post-intervention (week 12)

Secondary Outcomes (9)

• Cognitive Failures Questionnaire (CFQ)

  Pre-intervention (week 0) and post-intervention (week 12)

• Dysexecutive Questionnaire (DEX)

  Pre-intervention (week 0) and post-intervention (week 12)

• Trail Making Test (TMT)

  Pre-intervention (week 0) and post-intervention (week 12)

• Controlled Oral Word Association (COWA)

  Pre-intervention (week 0) and post-intervention (week 12)

• The Activity Card Sort (ACS)

  Pre-intervention (week 0) and post-intervention (week 12)

Study Arms (2)

Metacognitive strategy training (MCST)

EXPERIMENTAL

Each MCST session will be follow the procedures of Cognitive Orientation to daily Occupational Performance (CO-OP) intervention. There will be 10, 45-minute, weekly sessions. All sessions will be delivered in-person with a trained occupational therapist.

Behavioral: Metacognitive Strategy Training (MCST)

Inactive Control Group

ACTIVE COMPARATOR

Participants will receive a weekly phone call from study staff to maintain contact and monitor changes in activity.

Behavioral: Inactive Control Group

Interventions

Metacognitive Strategy Training (MCST) BEHAVIORAL

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 subject identifies a GOAL, and then is guided by the therapist to discover a PLAN to potentially achieve the goal. The subject is then asked to DO the plan (if feasible during the therapy session otherwise asked to complete at home prior to the next treatment session), and subsequently to CHECK to see if the plan worked, i.e. the goal was achieved. This process is repeated until satisfactory performance is met for each established goal.

Metacognitive strategy training (MCST)

Inactive Control Group BEHAVIORAL

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.

Inactive Control Group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

RECRUITING

Related Publications (11)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 21440699 BACKGROUND

• Haskins E. Cognitive Rehabilitation Manual: Translating Evidence-Based Recommendations into Practice. vol 1. American Congress of Rehabilitation Medicine; 2012.

  BACKGROUND

• 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.

  PMID: 27449501 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Anna E Boone, PhD, OTR/L

  University of Missouri Occupational Therapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna E. Boone, PhD, OTR/L

CONTACT

5738827023; booneae@umsystem.edu

Juliana H. Earwood, OTD, OTR/L

CONTACT

5738846681; jmhudson@health.missouri.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All outcomes assessors will be blinded to participant study group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 9, 2024
• Study Start: October 31, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (1)