Moving On - An RCT to Test Physical Therapy Education

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Moving On After Breast Cancer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial, longitudinal and prospective
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moving On After Breast Cancer - Intervention Arm<br>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. | Behavioral: Moving On After Breast Cancer<br>* Patient education intervention that is evidence-based, physical therapy, patient & family centered through the use of face to face instruction, a booklet, and therapeutic exercise DVD. The education materials are designed to deliver information on short term, long term, and late physical and functional effects of breast cancer treatment and given to breast cancer survivors before beginning cancer treatment. The education materials are designed to be used before, during, and after breast cancer treatment.<br>* Other names: Intervention arm;|
| No Intervention: Usual Care<br>Participants are randomized to the usual care 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). Usual care consists of pre-operative testing, pre-operative nursing education on care of the surgical incision and pain management followed by breast cancer surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in active shoulder range of motion | 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. | 3 months |