N/A
N=45
Metacognitive Strategy Training in Cancer-related Cognitive Impairment
Breast Cancer Female
Bottom Line
View on ClinicalTrials.gov: NCT05505045 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Telehealth Usability Questionnaire (TUQ) — 6.38; 6.31 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CO-OP Procedures (Behavioral); Attention Control Procedures (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- University of Missouri-Columbia
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Telehealth Usability Questionnaire (TUQ) |
6.38; 6.31 | — |
| PRIMARY Acceptability of Intervention Measure (AIM) |
4.58; 4.25 | — |
| PRIMARY Intervention Appropriateness Measure (IAM) |
4.43; 3.83 | — |
| PRIMARY Feasibility of Intervention Measure (FIM) |
4.64; 4.20 | — |
| PRIMARY Canadian Occupational Performance Measure (COPM) Trained Goal Performance |
4.4; 4.1; 6.83; 5.7 | — |
| PRIMARY NeuroQoL Cognitive Function Short Form |
36.4; 37.2; 44.0; 42.6 | — |
| PRIMARY Canadian Occupational Performance Measure (COPM) Trained Goal Satisfaction |
4.2; 3.4; 6.9; 5.4 | — |
| SECONDARY Functional Assessment of Cancer Therapy-Breast (FACT-B) |
91.9; 90; 99.8; 104.3 | — |
| SECONDARY Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference Subtest |
10.2; 9.9; 11.2; 10.3 | — |
| SECONDARY Wechsler Adult Intelligence Scale (WAIS)-IV Letter-Number, Coding, Symbol Search Subtest |
9.4; 9.6; 10.6; 10.1; 10.5; 9.2 | — |
| SECONDARY Brief Visuospatial Memory Test -Revised Trial 1 |
51.0; 56.4; 47.0; 54.8 | — |
| SECONDARY Paced Auditory Serial Addition Test |
26.8; 26.2; 29.9; 25.7 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities |
45.5; 47.1; 48.2; 49.7 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- 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)
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 function (e.g., Parkinson's disease, dementia, cerebral infarcts, traumatic brain injury)
- severe depressive symptoms (Personal Health Questionnaire (PHQ-9) score of ≥21)
Data sourced from ClinicalTrials.gov (NCT05505045). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.