Actively Recruiting

Phase Not Applicable
Age: 20Years - 75Years
FEMALE
ID06545045

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

Led by University of Missouri-Columbia · Updated on 2026-02-19

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Missouri-Columbia

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying breast cancer survivors who experience cancer-related cognitive impairment (CRCI), which affects memory, problem-solving, and processing speed. This trial aims to assess the feasibility and early effects of metacognitive strategy training (MCST) to improve daily activities, cognition, and quality of life. It also examines changes in brain connectivity through neuroimaging compared to an inactive control group. The study is sponsored by the University of Missouri-Columbia and uses a randomized, single-blind design. Participants in the MCST group will receive 10 weekly, 45-minute in-person sessions led by a trained occupational therapist using the Cognitive Orientation to daily Occupational Performance (CO-OP) approach. This method teaches a global cognitive strategy to help participants set and achieve functional goals. The control group will receive weekly phone calls for social contact and to monitor cognitive symptom changes. Both groups will be followed over approximately 12 weeks. Throughout the study, participants will undergo assessments before and after the intervention, including measures of activity performance, satisfaction, and various cognitive tests. Researchers will collect data on feasibility and use questionnaires to evaluate cognitive failures, executive function, memory, and quality of life. Weekly phone calls will support participant engagement and monitor changes. The study duration is about 12 weeks, with ongoing evaluation of cognitive and functional outcomes.

CONDITIONS

Brief Title

Cognitive Rehabilitation Following Breast Cancer Treatment

Who Can Participate

Age: 20Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Self-reported cancer-related cognitive impairment with moderate to extreme dysfunction and a Cognitive Failures Questionnaire score over 30
  • Completed treatment for invasive ductal or lobular breast cancer (Stages I, II, or III) between 6 months and 3 years prior
  • Able to read, write, and speak English fluently
  • Able to provide valid informed consent
  • Life expectancy greater than 6 months at enrollment
  • On stable doses of medications affecting cognitive function (e.g., anti-depressants) with no changes in past 90 days
Not Eligible

You will not qualify if you...

  • Prior cancer diagnoses at other sites with active disease within the past year
  • Active acute or chronic brain-related neurological conditions affecting brain anatomy or function (e.g., Parkinson's disease, dementia)
  • Dementia symptoms indicated by a Montreal Cognitive Assessment score below 23
  • Severe depressive symptoms with a Personal Health Questionnaire-9 score of 21 or higher
  • History of severe traumatic brain injury or prolonged loss of consciousness
  • Conditions that prevent MRI scanning (e.g., electrical implants, pumps, claustrophobia)
  • Blue-yellow colorblindness
  • Pregnancy

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Approximately 12 weeks

Participants in the experimental group receive 10 weekly, 45-minute in-person sessions of Metacognitive Strategy Training (MCST) with a trained occupational therapist. Participants in the control group receive weekly phone calls to maintain contact and monitor changes.

Weekly visits or calls for 10 weeks

Follow-up

Duration - Immediately following the 12-week treatment period

Participants complete post-intervention assessments to evaluate changes in cognitive performance and other outcomes after treatment.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

University of Missouri

Columbia, Missouri, United States, 65211

Actively Recruiting

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Research Team

A

Anna E. Boone, PhD, OTR/L

J

Juliana H. Earwood, OTD, OTR/L

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Objective and subjective cognitive impairment following chemotherapy for cancer: a systematic review.

Amanda D Hutchinson, Jessica R Hosking, Ganessan Kichenadasse...

https://pubmed.ncbi.nlm.nih.gov/22658913

The Feasibility of Using Metacognitive Strategy Training to Improve Cognitive Performance and Neural Connectivity in Women with Chemotherapy-Induced Cognitive Impairment.

Timothy J Wolf, Meghan Doherty, Dorina Kallogjeri...

https://pubmed.ncbi.nlm.nih.gov/27449501