Moving On - An RCT to Test Physical Therapy Education

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: Moving On After Breast Cancer

• Registration Number: NCT04731805
• Lead Sponsor: Northeastern University

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.

Study Timeline

• Study Start: 2012-05-23
• Primary Completion: 2015-05-22
• Study Completion: 2015-05-22
• Status Verified: 2021-01
• Study First Submitted: 2021-01-24
• Study First Submitted QC: 2021-01-28
• Last Update Submitted: 2021-01-28
• Study First Posted: 2021-02-01
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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
• Female
• 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
• Dementia
• History of other previous cancers (except non-melanoma skin)
• Systemic medical conditions (e.g.: fibromyalgia, rheumatoid arthritis, etc.)
• Amputation of either upper extremity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moving On After Breast Cancer - Intervention Arm	Moving On After Breast Cancer	Participants are randomized to the intervention arm after their breast cancer diagnosis (but before cancer surgery) and baseline measurements (T0) are taken. They are followed up again at 2 weeks after their breast cancer surgery (T1), and again at 3 months after surgery (T2). Participants are given the patient education materials (booklet, therapeutic exercise DVD, small ball, range of motion wand). The research assistant orients the participant to the education materials and summarizes each section of the booklet. The research assistant also teaches the participant how to do the therapeutic exercises in the booklet. All participants in the intervention also receive usual care.

Primary Outcome Measures

Name	Time	Method
Change in active shoulder range of motion	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.