Sensorimotor Rehabilitation Program in Improving Quality of Life in Patients With Early Stage Breast Cancer
October 10, 2022 updated by: Amy Darragh, Ohio State University Comprehensive Cancer Center
The Effects of a Sensorimotor Rehabilitation Program on the Upper and Lower Limbs of Persons With Cancer Following Taxane-Based Chemotherapy for Early Stage Breast Cancer
This clinical trial studies how well the sensorimotor rehabilitation program works in improving quality of life in patients with early stage breast cancer.
A hand and foot sensory improvement program from occupational and physical therapists may improve patients' function in everyday tasks and overall quality of life.
Study Overview
Status
Completed
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. To investigate the effects of an innovative, new sensorimotor rehabilitation program on persons with cancer following taxane-based chemotherapy for early stage breast cancer.
OUTLINE:
Patients attend 1 therapy session to receive education and training in the use of the home program. Patients then complete exercises over 90 minutes per week for 6 weeks.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Ohio State University Comprehensive Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Persons with a primary diagnosis of grade 1 or greater peripheral neuropathy of the upper and lower extremities
- Taxane-based chemotherapy for early stage breast cancer
- Diagnosis of early stage breast cancer
Exclusion Criteria:
- Individuals with late stage breast cancer
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Supportive Care (sensorimotor rehabilitation program)
Patients attend 1 therapy session to receive education and training in the use of the home program.
Patients then complete exercises over 90 minutes per week for 6 weeks.
|
Ancillary studies
Other Names:
Ancillary studies
Ancillary studies
Attend a therapy session
Other Names:
Complete exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identify differences in patients scores using post-test scores on the McGill Pain Questionnaire
Time Frame: Up to 2 years
|
The McGill Pain Questionnaire-Short Form (MPQ-SF).
The purpose of the MPQ-SF is to rate qualities and intensities of pain.
Fifteen words describe pain and the subject rates the pain words using a 4-point Likert scale.
A visual analogue scale is used to identify intensity of pain and symptoms are rated on current and length of pain.
The MPQ-SF has been shown to be a valid and reliable tool in the assessment of pain and specifically the assessment of cancer pain.7.8,9
The Breast Edge Task Force Outcomes Committee rated the MPQ-SF as "highly recommend" for use in the breast cancer population.
|
Up to 2 years
|
|
Evaluate patients using post-test scores on the CIPN-20
Time Frame: Up to 2 years
|
The purpose of the CIPN-20 is to identify quality of life.
Twenty items are used to identify symptoms and functional limitations related to CIPN.
Three subscales represent sensory, motor, and autonomic function and provide a more complete picture of the nature, frequency, and severity of CIPN.
The CIPN-20 is a multidimensional scale that was specifically developed to capture patients' symptoms and functional limitations as related to CIPN 11,12.
The CIPN-20 is best utilized when combined with other pain and quality of life tools.
|
Up to 2 years
|
|
Assess the differences in patients post-test scores on the Disability of Arm Hand and Shoulder scores
Time Frame: Up to 2 years
|
The purpose of the Quick-DASH is to measure physical function and symptoms of persons with musculoskeletal disorders of the upper limb.
3 It is a shortened version of the DASH, using 11 items instead of 30.
In the breast cancer population, the DASH has shown good outcome measures when testing physical, social and psychological concerns.13,14
The DASH is highly recommended in the breast cancer population and the Quick DASH is also recommended but has not been used as frequently in research.
|
Up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Amy Darragh, PhD, OTR/L, Ohio State University Comprehensive Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 2, 2015
Primary Completion (Actual)
February 8, 2018
Study Completion (Actual)
September 14, 2022
Study Registration Dates
First Submitted
March 20, 2018
First Submitted That Met QC Criteria
June 20, 2018
First Posted (Actual)
June 26, 2018
Study Record Updates
Last Update Posted (Actual)
October 12, 2022
Last Update Submitted That Met QC Criteria
October 10, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSU-14219
- NCI-2017-01583 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.