Breast Cancer FemaleNCT06545045
Cognitive Rehabilitation Following Breast Cancer Treatment
A study testing Metacognitive Strategy Training (MCST) in people with Breast Cancer Female, run by University of Missouri-Columbia at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Metacognitive Strategy Training (MCST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Missouri
Columbia, Missouri, 65211
Anna E Boone, 5738827023, booneae@umsystem.edu
Juliana H Earwood, 5738846681, jmhudson@health.missouri.edu
About this study
Official title: Pilot Testing of Metacognitive Strategy Training to Address Cancer-related Cognitive Impairment in Breast Cancer
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.
Read the detailed description
Breast cancer survivors often self-report cognitive deficits, primarily in executive functioning (planning, problem solving, multitasking), memory, and processing speed after cancer treatment, i.e., cancer-related cognitive impairment (CRCI). The prevalence of CRCI following breast cancer is as high as 78% and can persist chronically after treatment has ended. In other health conditions associated with cognitive impairment, such as traumatic brain injury, the only evidence-based recommended practice standard for deficits in executive function is metacognitive strategy training (MCST). In this approach, participants are taught a general cognitive strategy that can be applied in known and novel contexts to devise task specific strategies to successfully engage in an activity. While the cognitive deficits identified in and described by breast cancer survivors seem quite amenable to MCST, there is no study in the published literature which measures the efficacy of MCST on CRCI. The Cognitive Orientation to daily Occupational Performance (CO-OP) approach is a MCST intervention in which subjects are taught a general cognitive strategy that can be applied in known and novel contexts to devise task specific strategies to engage in an activity. Preliminary data suggest that CO-OP may have a positive impact on subjective and objective cognitive performance in breast cancer survivors with CRCI. Further, this study will evaluate the neurophysiological underpinnings associated with treatment changes through the use of neuroimaging methods.
- Conditions
- Breast Cancer Female
- Being tested
- Metacognitive Strategy Training (MCST), Inactive Control Group
- Keywords
- Cancer, Breast Cancer, Cognition, Metacognition, Activities of daily living
- Medical subject headings
- Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive Strategy Training (MCST)Behavioural
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.
Inactive Control GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Inactive Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility measures
Recruitment rate, retention rate
Measured: 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.
Measured: 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.
Measured: Pre-intervention (week 0) and post-intervention (week 12)
Secondary outcomes (9)
Cognitive Failures Questionnaire (CFQ)
Self-report measure of lapses in motor function memory and perception. This questionnaire contains 25 items and scores range from 0 to 100. Higher scores = greater perceived impairment.
Measured: Pre-intervention (week 0) and post-intervention (week 12)
Dysexecutive Questionnaire (DEX)
Self-report measure of the functional impact of executive dysfunction. It consists of 20 items within four domains: (1) emotional, (2) motivational, (3) behavioral, and (4) cognitive. Each item is rated for frequency using a 5-point Likert scale ranging from 0 (never) to 4 (very often).
Measured: Pre-intervention (week 0) and post-intervention (week 12)
Trail Making Test (TMT)
Part A is an attention, visual search, and motor speed task that involves connecting a series of numbers in ascending order. Part B requires alternating between numbers and letters to assess set shifting and executive abilities.
Measured: Pre-intervention (week 0) and post-intervention (week 12)
Controlled Oral Word Association (COWA)
Measure of verbal fluency that requires spontaneous word production for a different letter of the alphabet across three different trials.
Measured: Pre-intervention (week 0) and post-intervention (week 12)
The Activity Card Sort (ACS)
Self-report measure of participation in various everyday life activities that are in the categories of low demand leisure, high demand leisure, instrumental activities of daily living, and social activity. Cards are sorted according to if the subject is performing each activity as much, less than, or more as compared to before experiencing cancer-related cognitive impairment.
Measured: Pre-intervention (week 0) and post-intervention (week 12)
Functional Assessment of Cancer Therapy-Breast (FACT-B)
A quality-of-life measure across five domains: Physical, social, emotional, functional well-being, and breast-cancer subscale.
Measured: Pre-intervention (week 0) and post-intervention (week 12)
Participation Strategies Self Efficacy Scale (PS-SES)
Self-report measure of self-efficacy in using participation strategies. The subject rates confidence across 35 items within six subscales: (1) managing home participation, (2) staying organized, (3) planning and managing community participation, (4) managing work and productivity), (5) managing communication, and (6) advocating for resources.
Measured: Pre-intervention (week 0) and post-intervention (week 12)
Paced Auditory Serial Addition Test (PASAT)
Measure of working memory and attention in which a series of single digit numbers are presented audibly individuals. The most recent two digits are to be summed prior to the next digit presented. Two commonly used subversions use a 2 second or 3 second inter-stimulus interval.
Measured: Pre-intervention (week 0) and post-intervention (week 12)
Hopkins Verbal Learning Test-Revised (HVLT-R)
Measure of verbal learning and memory in which a list of 12 words is to be recalled. Three learning trials with free recall followed by a delayed recall at 20 minutes and a recognition trial.
Measured: Pre-intervention (week 0) and post-intervention (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start31 Oct 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Anna Boone, University of Missouri-Columbia
- Investigators
- Anna E Boone, PhD, OTR/L, Principal investigator, University of Missouri Occupational Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545045
- Sponsor's protocol ID
- 2101565
- Other IDs
- 1R21CA286404
- Status last verified
- Feb 2026
- First submitted
- 5 Aug 2024
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22658913O'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.
PubMed 23483375Schagen 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.
PubMed 26217131Myers JS. Chemotherapy-related cognitive impairment. Clin J Oncol Nurs. 2009 Aug;13(4):413-21. doi: 10.1188/09.CJON.413-421.
PubMed 19648097Janelsins 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.
PubMed 21600374Wefel JS, Schagen SB. Chemotherapy-related cognitive dysfunction. Curr Neurol Neurosci Rep. 2012 Jun;12(3):267-75. doi: 10.1007/s11910-012-0264-9.
PubMed 22453825Janelsins 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.
PubMed 24716504Cicerone 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.
PubMed 11128897Cicerone 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.
PubMed 21440699Haskins E. Cognitive Rehabilitation Manual: Translating Evidence-Based Recommendations into Practice. vol 1. American Congress of Rehabilitation Medicine; 2012.
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.
PubMed 27449501
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing of Metacognitive Strategy Training to Address Cancer-related Cognitive Impairment in Breast Cancer
- ClinicalTrials.gov ID
- NCT06545045
- Acronym / sponsor ID
- 2101565
- Conditions
- Breast Cancer Female
- Keywords
- Cancer, Breast Cancer, Cognition, Metacognition, Activities of daily living
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Breast cancer survivors often self-report cognitive deficits, primarily in executive functioning (planning, problem solving, multitasking), memory, and processing speed after cancer treatment, i.e., cancer-related cognitive impairment (CRCI). The prevalence of CRCI following breast cancer is as high as 78% and can persist chronically after treatment has ended. In other health conditions associated with cognitive impairment, such as traumatic brain injury, the only evidence-based recommended practice standard for deficits in executive function is metacognitive strategy training (MCST). In this approach, participants are taught a general cognitive strategy that can be applied in known and novel contexts to devise task specific strategies to successfully engage in an activity. While the cognitive deficits identified in and described by breast cancer survivors seem quite amenable to MCST, there is no study in the published literature which measures the efficacy of MCST on CRCI. The Cognitive Orientation to daily Occupational Performance (CO-OP) approach is a MCST intervention in which subjects are taught a general cognitive strategy that can be applied in known and novel contexts to devise task specific strategies to engage in an activity. Preliminary data suggest that CO-OP may have a positive impact on subjective and objective cognitive performance in breast cancer survivors with CRCI. Further, this study will evaluate the neurophysiological underpinnings associated with treatment changes through the use of neuroimaging methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metacognitive strategy training (MCST) | Experimental | Behavioral: Metacognitive Strategy Training (MCST)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. |
| Inactive Control Group | Active comparator | Behavioral: Inactive Control GroupParticipants will receive a weekly phone call from study staff to maintain contact and monitor changes in activity. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metacognitive Strategy Training (MCST)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. | Behavioural | Metacognitive strategy training (MCST) |
| Inactive Control GroupWeekly 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. | Behavioural | Inactive Control Group |
Primary outcome
Feasibility measures
Time frame: After study completion, an average of 12 weeks
Recruitment rate, retention rate
Canadian Occupational Performance Measure (COPM) Performance
Time frame: Pre-intervention (week 0) and post-intervention (week 12)
Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.
Canadian Occupational Performance Measure (COPM) Satisfaction
Time frame: Pre-intervention (week 0) and post-intervention (week 12)
Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.
9 secondary outcomes
Cognitive Failures Questionnaire (CFQ)
Time frame: Pre-intervention (week 0) and post-intervention (week 12)
Dysexecutive Questionnaire (DEX)
Time frame: Pre-intervention (week 0) and post-intervention (week 12)
Trail Making Test (TMT)
Time frame: Pre-intervention (week 0) and post-intervention (week 12)
Controlled Oral Word Association (COWA)
Time frame: Pre-intervention (week 0) and post-intervention (week 12)
The Activity Card Sort (ACS)
Time frame: Pre-intervention (week 0) and post-intervention (week 12)
Functional Assessment of Cancer Therapy-Breast (FACT-B)
Time frame: Pre-intervention (week 0) and post-intervention (week 12)
Participation Strategies Self Efficacy Scale (PS-SES)
Time frame: Pre-intervention (week 0) and post-intervention (week 12)
Paced Auditory Serial Addition Test (PASAT)
Time frame: Pre-intervention (week 0) and post-intervention (week 12)
Hopkins Verbal Learning Test-Revised (HVLT-R)
Time frame: Pre-intervention (week 0) and post-intervention (week 12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Background: PubMed 22658913Hutchinson 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.
- Background: PubMed 23483375O'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.
- Background: PubMed 26217131Schagen 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.
- Background: PubMed 19648097Myers JS. Chemotherapy-related cognitive impairment. Clin J Oncol Nurs. 2009 Aug;13(4):413-21. doi: 10.1188/09.CJON.413-421.
- Background: PubMed 21600374Janelsins 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.
- Background: PubMed 22453825Wefel JS, Schagen SB. Chemotherapy-related cognitive dysfunction. Curr Neurol Neurosci Rep. 2012 Jun;12(3):267-75. doi: 10.1007/s11910-012-0264-9.
- Background: PubMed 24716504Janelsins 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.
- Background: PubMed 11128897Cicerone 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.
- Background: PubMed 21440699Cicerone 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.
- BackgroundHaskins E. Cognitive Rehabilitation Manual: Translating Evidence-Based Recommendations into Practice. vol 1. American Congress of Rehabilitation Medicine; 2012.
- Background: PubMed 27449501Wolf 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna E Boone, PhD, OTR/L principal investigator
University of Missouri Occupational Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive Strategy Training (MCST) in people with Breast Cancer Female, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna E. Boone, PhD, OTR/L (5738827023, booneae@umsystem.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility measures (time frame: After study completion, an average of 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06545045, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.