Adults 40 to 80, female only, with Breast Cancer Female. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Telehealth Usability Questionnaire (TUQ)Primary· After study completion, an average of 14 weeks
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).
Group
Value
95% CI
Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP)
6.38
± 0.61
Attention Control Group
6.31
± 0.61
Acceptability of Intervention Measure (AIM)Primary· After study completion, an average of 14 weeks
Measure of intervention acceptability. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)
Group
Value
95% CI
Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP)
4.58
± 0.55
Attention Control Group
4.25
± 0.58
Intervention Appropriateness Measure (IAM)Primary· After study completion, an average of 14 weeks
Measure of intervention appropriateness. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)
Group
Value
95% CI
Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP)
4.43
± 0.62
Attention Control Group
3.83
± 0.90
Feasibility of Intervention Measure (FIM)Primary· After study completion, an average of 14 weeks
Measure of intervention feasibility. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)
Group
Value
95% CI
Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP)
4.64
± 0.53
Attention Control Group
4.20
± 1.06
Canadian Occupational Performance Measure (COPM) Trained Goal PerformancePrimary· Pre-intervention (week 0) and post-intervention (week 14)
Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.
Baseline
Group
Value
95% CI
Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP)
4.4
± 1.3
Attention Control Group
4.1
± 1.6
Post
Group
Value
95% CI
Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP)
6.83
± 1.2
Attention Control Group
5.7
± 1.7
NeuroQoL Cognitive Function Short FormPrimary· Pre-intervention (week 0) and post-intervention (week 14)
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.
Baseline
Group
Value
95% CI
Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP)
36.4
± 5.9
Attention Control Group
37.2
± 6.3
Post
Group
Value
95% CI
Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP)
44.0
± 6.8
Attention Control Group
42.6
± 6.3
Canadian Occupational Performance Measure (COPM) Trained Goal SatisfactionPrimary· After study completion, an average of 14 weeks
Self-report measure of satisfaction level with activity performance. Minimum = 1, Maximum = 10. Higher scores mean higher satisfaction.
Baseline
Group
Value
95% CI
Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP)
4.2
± 2.3
Attention Control Group
3.4
± 1.8
Post
Group
Value
95% CI
Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP)
6.9
± 1.5
Attention Control Group
5.4
± 2.3
Functional Assessment of Cancer Therapy-Breast (FACT-B)Secondary· Pre-intervention (week 0) and post-intervention (week 14)
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.
Baseline
Group
Value
95% CI
Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP)
91.9
± 23.3
Attention Control Group
90
± 21.6
Post
Group
Value
95% CI
Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP)
99.8
± 21.8
Attention Control Group
104.3
± 14.3
Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference SubtestSecondary· Pre-intervention (week 0) and post-intervention (week 14)
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.
Baseline
Group
Value
95% CI
Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP)
10.2
± 2.5
Attention Control Group
9.9
± 2.4
Post
Group
Value
95% CI
Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP)
11.2
± 3.1
Attention Control Group
10.3
± 2.6
Wechsler Adult Intelligence Scale (WAIS)-IV Letter-Number, Coding, Symbol Search SubtestSecondary· Pre-intervention (week 0) and post-intervention (week 14)
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.
Letter Number Baseline
Group
Value
95% CI
Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP)
9.4
± 2.4
Attention Control Group
9.6
± 3.6
Letter Number Post
Group
Value
95% CI
Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP)
10.6
± 3.1
Attention Control Group
10.1
± 2.3
Symbol Search Baseline
Group
Value
95% CI
Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP)
10.5
± 2.6
Attention Control Group
9.2
± 2.3
Symbol Search Post
Group
Value
95% CI
Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP)
12.2
± 2.3
Attention Control Group
11.1
± 3.1
Coding Baseline
Group
Value
95% CI
Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP)
10.6
± 2.6
Attention Control Group
9.8
± 2.6
Coding Post
Group
Value
95% CI
Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP)
9.4
± 2.7
Attention Control Group
9.8
± 2.6
Brief Visuospatial Memory Test -Revised Trial 1Secondary· Pre-intervention (week 0) and post-intervention (week 14)
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.
Baseline
Group
Value
95% CI
Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP)
51.0
± 11.4
Attention Control Group
56.4
± 12.0
Post
Group
Value
95% CI
Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP)
47.0
± 9.4
Attention Control Group
54.8
± 16.2
Paced Auditory Serial Addition TestSecondary· Pre-intervention (week 0) and post-intervention (week 14)
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.
Baseline
Group
Value
95% CI
Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP)
26.8
± 10.2
Attention Control Group
26.2
± 6.8
Post
Group
Value
95% CI
Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP)
29.9
± 10.7
Attention Control Group
25.7
± 9.4
Adverse events — posted to ClinicalTrials.gov
Time frame: Through study completion, up to 14 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP)
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Missouri-Columbia
Last refreshed: 16 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05505045.