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Cognitive Rehabilitation for Cancer-related Cognitive Impairment

N/A

Recruiting

Led By Anna E Boone, PhD, OTR/L

Research Sponsored by University of Missouri-Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after study completion, an average of 14 weeks

Awards & highlights

Study Summary

This trial is testing the feasibility of delivering a cognitive rehabilitation program remotely to breast cancer survivors with self-reported cognitive impairment. The team hypothesizes that the program will have a positive effect on activity performance, subjective and objective cognition, and quality of life.

Who is the study for?

This trial is for English-speaking breast cancer survivors who finished chemotherapy within the last 3 years and are experiencing self-reported cognitive issues. They should expect to live more than 6 months, be on stable medication doses, and have no other active cancers or severe neurological conditions.Check my eligibility

What is being tested?

The study tests CO-OP (Cognitive Orientation to daily Occupational Performance) delivered remotely against an attention control procedure. It aims to improve activity performance, cognition, and quality of life in those reporting post-cancer treatment cognitive impairments.See study design

What are the potential side effects?

Since this trial involves non-medical interventions focusing on strategy training and attention control procedures, traditional side effects like with drugs are not expected. Participants may experience fatigue or frustration.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after study completion, an average of 14 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after study completion, an average of 14 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and after study completion, an average of 14 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability of Intervention Measure (AIM)

Canadian Occupational Performance Measure (COPM)

Feasibility measures

+4 more

Secondary outcome measures

Brief Visuospatial Memory Test -Revised

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

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

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment Group: Cognitive Orientation to daily Occupational Performance (CO-OP)Experimental Treatment1 Intervention

Each 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.

Group II: Attention Control GroupActive Control1 Intervention

Each 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor

361 Previous Clinical Trials

627,950 Total Patients Enrolled

1 Trials studying Breast Cancer

130 Patients Enrolled for Breast Cancer

Anna E Boone, PhD, OTR/LPrincipal InvestigatorUniversity of Missouri Occupational Therapy

2 Previous Clinical Trials

93 Total Patients Enrolled

Media Library

CO-OP Procedures Clinical Trial Eligibility Overview. Trial Name: NCT05505045 — N/A

Breast Cancer Research Study Groups: Treatment Group: Cognitive Orientation to daily Occupational Performance (CO-OP), Attention Control Group

Breast Cancer Clinical Trial 2023: CO-OP Procedures Highlights & Side Effects. Trial Name: NCT05505045 — N/A

CO-OP Procedures 2023 Treatment Timeline for Medical Study. Trial Name: NCT05505045 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently involved in this research effort?

"Affirmative, according to the information provided on clinicaltrials.gov this trial is presently enrolling patients. It was first posted on August 9th 2022 and the last update occurred November 10th 2022. The research team requires 44 individuals from 1 medical centre for their study."

Answered by AI

Is there an opportunity to participate in this clinical experiment?

"For this clinical trial, individuals aged 40-80 with neoplasms are offered participation. To qualify for enrollment, the patients must demonstrate a Cognitive Failures Questionnaire (CFQ) score of over 30, have completed chemotherapy in the last three years or less, be competent English speakers and readers, provide valid informed consent to participate; possess an estimated life expectancy of greater than six months at time of enrollment; and own a diagnosis of invasive ductal or lobular breast cancer stages I, II or III that has been treated with chemo within preceding three years while being on stable medication doses (no changes made in past 60 days)."

Answered by AI

Is the age criterion for participation in this experiment over 70 years of age?

"Qualified participants for this medical trial must be between the ages of 40 and 80. There are 89 trials available for those under 18 and 2,737 trials open to seniors aged 65 or above."

Answered by AI

What is the aim of this examination?

"This clinical trial aims to measure the efficacy of a new treatment by assessing participants' Canadian Occupational Performance Measure (COPM) scores over 14 weeks. Secondary objectives include measuring the participant's working memory via Paced Auditory Serial Addition Test, evaluating self-reported symptoms such as depression and anxiety with PROMIS-57 Profile v2.0 and determining quality of life through Functional Assessment of Cancer Therapy-Breast (FACT-B)."

Answered by AI

Are any additional participants being sought for this experiment?

"Affirmative. Clinicaltrials.gov provides evidence that this medical experiment, which was initially listed on August 9th 2022, is actively recruiting patients. Forty-four volunteers are needed from one particular location."

Answered by AI

Recent research and studies

Current Oncology ReportsJournal

Clearing the Air: A Review of Our Current Understanding of “chemo Fog

O’Farrell, Erin, Joyce MacKenzie, and Barbara Collins. 2013. “Clearing the Air: A Review of Our Current Understanding of “chemo Fog””. Current Oncology Reports. Springer Science and Business Media LLC. doi:10.1007/s11912-013-0307-7.

Archives of Physical Medicine and RehabilitationJournal

Evidence-based Cognitive Rehabilitation: Updated Review of the Literature from 2003 Through 2008

Cicerone, Keith D., Donna M. Langenbahn, Cynthia Braden, James F. Malec, Kathleen Kalmar, Michael Fraas, Thomas Felicetti, et al.. 2011. “Evidence-based Cognitive Rehabilitation: Updated Review of the Literature from 2003 Through 2008”. Archives of Physical Medicine and Rehabilitation. Elsevier BV. doi:10.1016/j.apmr.2010.11.015.

Psycho-OncologyJournal

Neuropsychological Functioning and Quality of Life During the First Year After Completing Chemotherapy for Breast Cancer

Reid-Arndt, Stephanie A., Catherine Hsieh, and Michael C. Perry. 2010. “Neuropsychological Functioning and Quality of Life During the First Year After Completing Chemotherapy for Breast Cancer”. Psycho-oncology. Wiley. doi:10.1002/pon.1581.

Cancer Treatment ReviewsJournal