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

Peripheral Neuropathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03568526
• Other study ID #: OSU-14219
• Secondary ID: NCI-2017-01583
• Status: Completed
• Phase: N/A
• Start date: July 2, 2015
• Est. completion date: September 14, 2022

Study information

• Verified date: October 2022
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 14, 2022
• Est. primary completion date: February 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Peripheral Nervous System Diseases
• 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

Intervention

Other:
• Educational Intervention
Attend a therapy session

Behavioral:
• Exercise Intervention
Complete exercise

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify differences in patients scores using post-test scores on the McGill Pain Questionnaire	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
Primary	Evaluate patients using post-test scores on the CIPN-20	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
Primary	Assess the differences in patients post-test scores on the Disability of Arm Hand and Shoulder scores	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

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