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Cognitive Rehabilitation Following Breast Cancer Treatment

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
20 Years to 75 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests training that helps breast cancer survivors plan and check their thinking during daily tasks. It is for survivors with cancer-related problems with memory or thinking. Researchers will see if the training is practical to use and may improve daily tasks, thinking, quality of life, and how brain areas work together, compared with a group that does not get the training.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Report moderate, strong, or extreme thinking problems related to cancer and score above 30 on the Cognitive Failures Questionnaire.
  • Finished treatment for stage I, II, or III invasive ductal or lobular breast cancer 6 months to 3 years ago. These cancers start in milk ducts or milk-making glands and spread into nearby breast tissue.
  • Can read, write, and speak English fluently.
  • Can give informed consent, meaning you understand the study and agree to join.
  • Are expected to live more than 6 months when joining.
  • Have had no dose changes in the past 90 days for medicines that affect thinking, such as antidepressants.

Who can't join

  • Had cancer in another part of the body that showed signs of being active within the past year.
  • Have a brain or nerve condition that changes brain structure or function, such as Parkinson’s disease, dementia, or stroke, or score below 23 on the Montreal Cognitive Assessment, a thinking test.
  • Have severe depression symptoms, with a PHQ-9 questionnaire score of 21 or higher.
  • Have had a severe brain injury or a long loss of consciousness, such as a coma.
  • Cannot safely have an MRI scan, such as because of an electrical implant or pump, or fear of enclosed spaces.
  • Have blue-yellow colorblindness.
  • Are pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

MO