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Clinical Trials/NCT04731805
NCT04731805
Completed
Not Applicable

"Moving On" - A Randomized Controlled Trial for Acceptability and Feasibility of an Early Physical Therapy Education Intervention for Breast Cancer Surgical Candidates

Northeastern University0 sites50 target enrollmentMay 23, 2012
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Northeastern University
Enrollment
50
Primary Endpoint
Change in active shoulder range of motion
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The purpose of this study is to test the acceptability, feasibility and explore the possible effects of an early physical therapy education intervention for breast cancer survivors.

Detailed Description

This study uses a randomized controlled and longitudinal study design. We will compare two groups - an intervention group and a control group - to test the effects of an early physical therapy education intervention for breast cancer survivors who are candidates for breast cancer surgery. Because of the nature of the intervention (patient early education with 1:1 discussion of educational materials) we will be unable to introduce blinding of the participant as well as the staff.

Registry
clinicaltrials.gov
Start Date
May 23, 2012
End Date
May 22, 2015
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ann Marie Flores

Assistant Professor

Northeastern University

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed with unilateral breast cancer
  • Candidate for breast cancer surgery as first line of cancer treatment
  • Undergo breast cancer surgery at Brigham and Woman's Hospital, Boston, Massachusetts
  • English speaking
  • Greater than or equal to 21 years old

Exclusion Criteria

  • Previous history of breast cancer and/or recurrent/metastatic disease
  • Receiving neoadjuvant chemotherapy treatment
  • Bilateral breast cancer
  • History of shoulder impairments or severe upper quarter scarring
  • Pregnancy
  • Central nervous system damage
  • History of other previous cancers (except non-melanoma skin)
  • Systemic medical conditions (e.g.: fibromyalgia, rheumatoid arthritis, etc.)
  • Amputation of either upper extremity

Outcomes

Primary Outcomes

Change in active shoulder range of motion

Time Frame: 3 months

Active shoulder range of motion is measured with a standard goniometer in degrees. Change from baseline to 3 months for shoulder flexion, extension, abduction, and internal and external ranges are measured.

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