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

Not Applicable

Completed

• Conditions: Stage IB Breast Cancer AJCC v7; Stage I Breast Cancer AJCC v7; Stage II Breast Cancer AJCC v6 and v7; Peripheral Neuropathy; Stage IA Breast Cancer AJCC v7; Stage IIB Breast Cancer AJCC v6 and v7; Stage IIA Breast Cancer AJCC v6 and v7
• Interventions: Other: Educational Intervention; Behavioral: Exercise Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survey Administration

• Registration Number: NCT03568526
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-07-02
• Primary Completion: 2018-02-08
• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-06-20
• Study First Posted: 2018-06-26
• Study Completion: 2022-09-14
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-10
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive Care (sensorimotor rehabilitation program)	Educational Intervention	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.
Supportive Care (sensorimotor rehabilitation program)	Questionnaire Administration	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.
Supportive Care (sensorimotor rehabilitation program)	Survey Administration	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.
Supportive Care (sensorimotor rehabilitation program)	Exercise Intervention	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.
Supportive Care (sensorimotor rehabilitation program)	Quality-of-Life Assessment	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.

Primary Outcome Measures

Name	Time	Method
Evaluate patients using post-test scores on the CIPN-20	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.
Assess the differences in patients post-test scores on the Disability of Arm Hand and Shoulder scores	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.
Identify differences in patients scores using post-test scores on the McGill Pain Questionnaire	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.

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States