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Sensorimotor Rehabilitation Program in Improving Quality of Life in Patients With Early Stage Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03568526
Recruitment Status : Active, not recruiting
First Posted : June 26, 2018
Last Update Posted : April 2, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Amy Darragh, Ohio State University Comprehensive Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Peripheral Neuropathy Stage I Breast Cancer AJCC v7 Stage IA Breast Cancer AJCC v7 Stage IB Breast Cancer AJCC v7 Stage II Breast Cancer AJCC v6 and v7 Stage IIA Breast Cancer AJCC v6 and v7 Stage IIB Breast Cancer AJCC v6 and v7 Other: Educational Intervention Behavioral: Exercise Intervention Other: Quality-of-Life Assessment Other: Questionnaire Administration Other: Survey Administration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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
Actual Study Start Date : July 2, 2015
Actual Primary Completion Date : February 8, 2018
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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.
Other: Educational Intervention
Attend a therapy session
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

Behavioral: Exercise Intervention
Complete exercise

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Other: Survey Administration
Ancillary studies




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568526


Locations
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United States, Ohio
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Amy Darragh, PhD, OTR/L Ohio State University Comprehensive Cancer Center

Additional Information:
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Responsible Party: Amy Darragh, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03568526    
Other Study ID Numbers: OSU-14219
NCI-2017-01583 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA016058 ( U.S. NIH Grant/Contract )
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: April 2, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Breast Neoplasms
Peripheral Nervous System Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neuromuscular Diseases
Nervous System Diseases