Clinical trial · Interventional
Cognitive Rehabilitation Following Breast Cancer Treatment
Pilot Testing of Metacognitive Strategy Training to Address Cancer-related Cognitive Impairment in Breast Cancer
NCT06545045CI-TRIAL-00103625recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Inactive Control Group | Behavioral | — | UNRESOLVED |
| Metacognitive Strategy Training (MCST) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Metacognitive strategy training (MCST)
- description
- 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.
- interventionNames
- Behavioral: Metacognitive Strategy Training (MCST)
- type
- ACTIVE_COMPARATOR
- label
- Inactive Control Group
- description
- Participants will receive a weekly phone call from study staff to maintain contact and monitor changes in activity.
- interventionNames
- Behavioral: Inactive Control Group
Primary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (11)
- BACKGROUNDHutchinson 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
- BACKGROUNDO'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
- BACKGROUNDSchagen 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
- BACKGROUNDMyers JS. Chemotherapy-related cognitive impairment. Clin J Oncol Nurs. 2009 Aug;13(4):413-21. doi: 10.1188/09.CJON.413-421. PMID 19648097
- BACKGROUNDJanelsins 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
- BACKGROUNDWefel 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
- BACKGROUNDJanelsins 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
- BACKGROUNDCicerone 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.