What is metacognitive strategy training (MCST) studying for breast cancer cognitive impairment?

Metacognitive strategy training (MCST) is being studied to help breast cancer survivors with cognitive problems after treatment. Researchers want to see if MCST can improve thinking skills, daily activities, and quality of life while also examining brain connectivity changes. The University of Missouri-Columbia sponsors this research to better support those affected by cancer-related cognitive impairment.

Who may be eligible for this breast cancer clinical trial?

Women aged 20 to 75 who have completed treatment for certain stages of breast cancer 6 months to 3 years ago may be eligible. Participants need to report cognitive difficulties and be on stable doses of certain medications. Please review eligibility criteria for more details.

Is there any cost to participate in this breast cancer clinical trial?

Study-related care, including the study sessions and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase Not Applicable

Age: 20Years - 75Years

FEMALE

ID06545045

Testing Metacognitive Strategy Training to Improve Thinking and Daily Activities in Women Treated for Breast Cancer

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

Participants Needed

Research Sites

N/A

Total Duration

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

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	MCST Cognitive Rehabilitation	Inactive Control (Weekly Social Contact)
What it is	A behavioral cognitive rehabilitation program where participants identify personal functional goals and learn to use a structured problem-solving strategy (GOAL-PLAN-DO-CHECK) through therapist-supported sessions.	A control group where participants receive weekly phone calls for engagement and social interaction, but no formal cognitive intervention, serving to mimic non-specific effects such as contact with study staff.
Role in the trial	Serves as the experimental intervention under active investigation for improving cognitive function after breast cancer treatment.	Serves as the comparator group to distinguish effects of the MCST intervention from general engagement or social contact.
Primary use	Intended to help breast cancer survivors with self-reported cognitive impairment improve their functioning in everyday life by teaching effective problem-solving and goal management strategies.	Intended to act as a neutral comparator, allowing measurement of the specific effects of MCST versus no structured cognitive rehabilitation.
How it is given or performed	MCST involves individualized sessions with a therapist, during which participants identify personal goals and are guided to develop, implement, and evaluate plans for achieving these goals using a metacognitive problem-solving approach.	Participants receive weekly phone calls from study staff to provide social engagement and maintain study contact, with no cognitive training provided.
Evidence status	Metacognitive strategy training for cancer-related cognitive impairment is considered promising, with feasibility and small-sample studies supporting its use, but large-scale efficacy is still under clinical investigation.	There is no established evidence that weekly social contact alone leads to improved cognitive function in breast cancer survivors with cognitive impairment.
Important limitations	Most existing evidence for MCST in cancer survivors comes from small studies and single centers. The long-term effectiveness and real-world implementation in diverse populations remain unclear.	Does not provide active cognitive rehabilitation, so does not reflect real-world therapy or clinical recommendations. Any measured effects may be limited to placebo or engagement.

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 20Years - 75Years

FEMALE

Eligibility Criteria

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

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

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)