CO-OP Procedures for Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Missouri Occupational Therapy Department, Columbia, MO
Neoplasms+2 More
CO-OP Procedures - Behavioral
Eligibility
18+
Female
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Neoplasms

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

7 Primary · 8 Secondary · Reporting Duration: After study completion, an average of 14 weeks

Week 14
Acceptability of Intervention Measure (AIM)
Feasibility measures
Feasibility of Intervention Measure (FIM)
Intervention Appropriateness Measure (IAM)
Telehealth Usability Questionnaire (TUQ)
Week 14
Brief Visuospatial Memory Test -Revised
Canadian Occupational Performance Measure (COPM)
Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference
Functional Assessment of Cancer Therapy-Breast (FACT-B)
Montreal Cognitive Assessment (MoCA)
NeuroQoL Cognitive Function Short Form
Paced Auditory Serial Addition Test
Patient Health Questionnaire (PHQ-9)
Patient-Reported Outcomes Measurement Information System (PROMIS-57) Profile v2.0
Wechsler Adult Intelligence Scale (WAIS)-IV Letter-Number Sequencing, Coding, Symbol Search subtests

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Attention Control Group
1 of 2
Treatment Group: Cognitive Orientation to daily Occupational Performance (CO-OP)
1 of 2
Active Control
Experimental Treatment

44 Total Participants · 2 Treatment Groups

Primary Treatment: CO-OP Procedures · No Placebo Group · N/A

Treatment Group: Cognitive Orientation to daily Occupational Performance (CO-OP)
Behavioral
Experimental Group · 1 Intervention: CO-OP Procedures · Intervention Types: Behavioral
Attention Control Group
Behavioral
ActiveComparator Group · 1 Intervention: Attention Control Procedures · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: after study completion, an average of 14 weeks
Closest Location: University of Missouri Occupational Therapy Department · Columbia, MO
Photo of columbia 1Photo of columbia 2Photo of columbia 3
N/AFirst Recorded Clinical Trial
0 TrialsResearching Neoplasms
0 CompletedClinical Trials

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor
326 Previous Clinical Trials
601,190 Total Patients Enrolled
2 Trials studying Neoplasms
133 Patients Enrolled for Neoplasms
Anna E Boone, PhD, OTR/LPrincipal InvestigatorUniversity of Missouri Occupational Therapy
1 Previous Clinical Trials
28 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a self-reported cognitive failure score of at least 30.
You have completed a full course of chemotherapy at least 6 months, but no later than 3 years, prior to participation.
You have a life expectancy of greater than 6 months at time of enrollment.
You have a diagnosis of breast cancer and have completed chemotherapy within the preceding three years.
You are on stable doses of medications.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References