The Effects of Pre-operative Physical Therapy Education

Study Overview
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Brief Summary
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It is expected that patients who receive physical therapy before surgery will have greater range of motion (ROM), strength, function, satisfaction, and less swelling, pain, and anxiety following surgery compared to those in the control group.

Official Title
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Phase 1 of the The Effects of Pre-operative Physical Therapy Education and Exercise on Patient Outcomes Post Breast Cancer Surgery: a Randomized Controlled Trial

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Education brochure
* Other: Live education and exercise instruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be over the age of 18, have a good understanding of the English language, and be scheduled to undergo either a mastectomy, lumpectomy, ALND or Sentinel Lymph Node Dissection (SLND) with or without breast reconstruction. Exclusion Criteria: if they previously underwent one of the previously mentioned procedures mastectomy, lumpectomy, ALND or Sentinel Lymph Node Dissection (SLND) with or without breast reconstruction.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Education brochure<br>The control group will receive a standard education brochure which will be provided pre-operatively to the participants. | Other: Education brochure<br> <br> |
| Experimental: Live education and exercise instruction<br>The intervention group will receive one to two physical therapy visits consisting of education on the lymphedema risks and prevention factors, along with detailed information about what to except post-surgery as well as with radiation/chemotherapy. Additionally, those in the intervention group will be instructed on exercises to maintain or increase glenohumeral and scapulothoracic joint ROM post surgery and will be set up with a walking program. | Other: Live education and exercise instruction<br>* Participants will receive one to two physical therapy visits consisting of education on the lymphedema risks and prevention factors, along with detailed information about what to except post-surgery as well as with radiation/chemotherapy. Additionally, those in the intervention group will be instructed on exercises to maintain or increase glenohumeral and scapulothoracic joint ROM post surgery and will be set up with a walking program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in score for Shoulder Pain and Disability Index (SPADI) | Functional outcome measure questionnaire | Before sugery (range 0-4 weeks before surgery), 2 weeks post operatively and 6 weeks post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Shoulder range of motion with goniometer |  | Pre-operatively (0-4 weeks pre-operatively), 2 and 6 weeks post-operatively |