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Breast Cancer FemaleNCT05505045

Metacognitive Strategy Training in Cancer-related Cognitive Impairment

A study testing CO-OP Procedures in people with Breast Cancer Female, run by University of Missouri-Columbia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The first aim of this study is to determine the feasibility of delivering CO-OP remotely to breast cancer survivors, who self-report cancer-related cognitive impairment (CRCI), in preparation for a future R01 trial. Read more about this study

Who is it for?
Ages 40 to 80 years, women only
Conditions the study is for
Breast Cancer Female
What is being tested?
CO-OP Procedures
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteUnited States
Study dates
11 Oct 2022to 4 Apr 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 40 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • self-reported CRCI (Cognitive Failures Questionnaire (CFQ) score >30)
  • completed full course of chemotherapy at least 6 months, but no later 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
  • diagnosed with breast cancer (invasive ductal or lobular BrCA Stages I, II, or III) and completed chemotherapy within the preceding three years
  • on stable doses of medications (i.e., no changes in past 60 days)

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 function (e.g., Parkinson's disease, dementia, cerebral infarcts, traumatic brain injury)
  • severe depressive symptoms (Personal Health Questionnaire (PHQ-9) score of ≥21)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Missouri Occupational Therapy Department

    Columbia, Missouri, 65203

Other trials in United States

About this study

Official title: Feasibility of Using Remotely-delivered Metacognitive Strategy Training to Address Cancer-related Cognitive Impairment in Breast Cancer

The first aim of this study is to determine the feasibility of delivering CO-OP remotely to breast cancer survivors, who self-report cancer-related cognitive impairment (CRCI), in preparation for a future R01 trial. The second aim of this study is to assess the effect of CO-OP on activity performance, subjective and objective cognition, and quality of life in a sample of breast cancer survivors who self-report CRCI. The research team hypothesizes that effect size estimations will indicate that CO-OP will have a greater positive effect, compared to attention control, on activity performance, subjective and objective cognition, and quality of life in a sample of breast cancer survivors who self-report CRCI.

Read the detailed description

Breast cancer survivors often self-report cognitive changes after treatment for cancer (e.g. cancer-related cognitive impairment (CRCI)). These cognitive changes have a devastating impact on everyday life activities, such as work/productivity, community involvement, driving, and financial management. While CRCI would likely be amenable to rehabilitation services, breast cancer survivors face two primary barriers to adequate rehabilitation, including (1) inadequate access to rehabilitation services, and (2) limited effective interventions to address CRCI.

Breast cancer survivors have inadequate access to rehabilitation services to address CRCI. A recent report sponsored by the National Cancer Institute (NCI) concluded that most NCI-designated cancer centers do not have integrated cancer rehabilitation services. Even if comprehensive rehabilitation services were provided by these centers, millions of cancer survivors live in rural areas outside close proximity to a cancer center and are more likely to experience poorer outcomes compared to urban counterparts. If rehabilitation services were provided, proximity to facilities may be a limiting factor in individuals from rural communities receiving rehabilitative care. Access to services has been further curtailed amid the COVID-19 pandemic, with calls building from national organizations for improvements in remote delivery of services.

Metacognitive strategy training (MCST) is a practice standard to address cognitive impairment in other conditions, such as traumatic brain injury and stroke. 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. The investigators' preliminary data suggest that CO-OP may have a positive impact on activity performance, subjective and objective cognition, and quality of life in breast cancer survivors with CRCI. While current evidence supports the remote delivery of strategy-based interventions like CO-OP, this intervention has not been evaluated in breast cancer survivors with CRCI.

The investigators' overall research hypothesis is that CO-OP can feasibly be administered remotely and will improve activity performance, subjective and objective cognition, and subjective quality of life in breast cancer survivors with CRCI.

Being tested
CO-OP Procedures, Attention Control Procedures
Keywords
cancer, metacognition, cognition, Telehealth, activities of daily living
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CO-OP ProceduresBehavioural

    CO-OP is a metacognitive strategy training intervention that will be used in this study. First, five functional, everyday life goals are identified collaboratively by the participant and interventionist. In the second meeting, we introduce the approach to the subject and teach the 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.

  • Attention Control ProceduresBehavioural

    Individuals in the attention control group will have dose-equivalent, weekly virtual contact through the Zoom platform for 12-weeks with a a trained interventionist not involved in CO-OP treatment. The control group will control for interpersonal interaction, maturation effects, and testing effects. The focus of each session will include: (1) social interaction characterized by warmth/empathy and (2) provision of usual care CRCI educational resources (e.g. exercise, using memory aids, minimizing distractions) from MD Anderson Cancer Center. These recommendations will be provided without further instruction. Any questions that arise regarding CRCI the subject is experiencing will be answered. The therapist will debrief with the subject on any changes in CRCI symptoms. The content and duration of each call will be tracked. Each session will be recorded with two randomly selected and reviewed for fidelity.

Study groups in NCT05505045
Study groupRoleWhat they receive
Treatment Group: Cognitive Orientation to daily Occupational Performance (CO-OP)ExperimentalEach CO-OP session will last 60 minutes and subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
Receives: Behavioral: CO-OP Procedures
Attention Control GroupActive comparatorEach session will last 60 minutes and subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
Receives: Behavioral: Attention Control Procedures

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Telehealth Usability Questionnaire (TUQ)

    Measure of telehealth usability from participant's perspective. Specifically, the TUQ measures usefulness and utility of technologies including usefulness, ease of use, effectiveness, reliability, and satisfaction. The TUQ uses a self-report Likert scale of 1 (disagree) to 7 (agree).

    Measured: After study completion, an average of 14 weeks

  2. Acceptability of Intervention Measure (AIM)

    Measure of intervention acceptability. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)

    Measured: After study completion, an average of 14 weeks

  3. Intervention Appropriateness Measure (IAM)

    Measure of intervention appropriateness. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)

    Measured: After study completion, an average of 14 weeks

  4. Feasibility of Intervention Measure (FIM)

    Measure of intervention feasibility. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)

    Measured: After study completion, an average of 14 weeks

  5. Canadian Occupational Performance Measure (COPM) Trained Goal 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 14)

  6. NeuroQoL Cognitive Function Short Form

    Self-report measure of cognitive ability in daily life activity. Maximum = 5 (never), Minimum = 1 (Very often/several times per day). The total raw score range is 8-40. The t-score is reported with a mean of 50 and standard deviation of 10. Higher scores mean fewer perceived cognitive challenges.

    Measured: Pre-intervention (week 0) and post-intervention (week 14)

  7. Canadian Occupational Performance Measure (COPM) Trained Goal Satisfaction

    Self-report measure of satisfaction level with activity performance. Minimum = 1, Maximum = 10. Higher scores mean higher satisfaction.

    Measured: After study completion, an average of 14 weeks

Secondary outcomes (6)

  1. Functional Assessment of Cancer Therapy-Breast (FACT-B)

    Self-report measure of quality of life for breast cancer survivors. Domains include questions related to physical, emotional, social, and functional well-being, as well as additional concerns. Minimum = 0 (not at all), Maximum = 4 (very much). The range of scores is 0 to 148. Higher scores indicate decreased perceived well-being and quality of life.

    Measured: Pre-intervention (week 0) and post-intervention (week 14)

  2. Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference Subtest

    Objective measure of inhibition and cognitive flexibility. Data are presented for condition 4 of Number/Letter switching. Age-adjusted scale scores with a mean of 10 and standard deviation of 3 are reported. The total range of scores is 1-19. Higher scores indicate better performance.

    Measured: Pre-intervention (week 0) and post-intervention (week 14)

  3. Wechsler Adult Intelligence Scale (WAIS)-IV Letter-Number, Coding, Symbol Search Subtest

    Objective measure of cognitive performance. The Letter-Number subtest measures working memory. The Coding and Symbol Search subtest measure processing speed. Higher scores indicate better cognitive performance. Age adjusted scaled scores with a mean of 10 and standard deviation of 3 are reported. Range of reported scores is 1 to 19.

    Measured: Pre-intervention (week 0) and post-intervention (week 14)

  4. Brief Visuospatial Memory Test -Revised Trial 1

    Objective measure of episodic memory. Participant is presented with six geometric figures for 10 seconds on three different occasions, and then asked to draw the six figures on a separate sheet of paper in the correct order. Increased errors may indicate challenges with episodic memory. T-scores are reported with a mean of 50 and standard deviation of 10. Higher scores indicate better performance.

    Measured: Pre-intervention (week 0) and post-intervention (week 14)

  5. Paced Auditory Serial Addition Test

    Objective measure of working memory. Participant is presented with single digits every 2 seconds and asked to add each digit to the one immediately prior to it. Total score is out of 60 points, with increased errors indicating challenges with working memory.

    Measured: Pre-intervention (week 0) and post-intervention (week 14)

  6. Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities

    Self-report measure of ability to participate in social roles and activities. Higher scores reflect higher abilities. T-scores are reported with a mean of 50 and a standard deviation of 10.

    Measured: Pre-intervention (week 0) and post-intervention (week 14)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2022
  2. Study start11 Oct 2022
  3. Primary completion4 Apr 2024
  4. Study completion4 Apr 2024

Resources

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
Model description
After baseline assessment, subjects will be randomized to one of two groups: (1) a 10-session Cognitive Orientation to daily Occupational Performance (CO-OP) intervention; or (2) a 10-session attention control group.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05505045
Sponsor's protocol ID
2066383
Status last verified
Oct 2024
First submitted
15 Aug 2022
Last updated
16 Dec 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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 22658913

  • O'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 23483375

  • Reid-Arndt SA, Hsieh C, Perry MC. Neuropsychological functioning and quality of life during the first year after completing chemotherapy for breast cancer. Psychooncology. 2010 May;19(5):535-44. doi: 10.1002/pon.1581.

    PubMed 19472296

  • Reid-Arndt SA, Yee A, Perry MC, Hsieh C. Cognitive and psychological factors associated with early posttreatment functional outcomes in breast cancer survivors. J Psychosoc Oncol. 2009;27(4):415-34. doi: 10.1080/07347330903183117.

    PubMed 19813133

  • Cicerone 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 11128897

  • Cicerone 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 21440699

  • Haskins E. Cognitive Rehabilitation Manual: Translating Evidence-Based Recommendations into Practice. Vol 1. Reston, VA: 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

Questions about this trial

What is this clinical trial studying?

A study testing CO-OP Procedures 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 7 inclusion and 3 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: finished, as of the sponsor's last update on 16 Dec 2024. 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?

Yes. Results are posted in the registry (first posted 16 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Telehealth Usability Questionnaire (TUQ) (time frame: After study completion, an average of 14 weeks). The study lists 7 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 NCT05505045, which also lists 8 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 16 Dec 2024.

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