Back to resultsThe Effects of Pre-operative Physical Therapy Education
Primary Purpose
Breast Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education brochure
Live education and exercise instruction
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer
Eligibility Criteria
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.
Sites / Locations
- St-Mary's of Michigan
- St. Mary's of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Education brochure
Live education and exercise instruction
Arm Description
The control group will receive a standard education brochure which will be provided pre-operatively to the participants.
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.
Outcomes
Primary Outcome Measures
Change in score for Shoulder Pain and Disability Index (SPADI)
Functional outcome measure questionnaire
Secondary Outcome Measures
Change in Shoulder range of motion with goniometer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01669187
Brief Title
The Effects of Pre-operative Physical Therapy Education
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Study withdrawn.
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oakland University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Education brochure
Arm Type
Active Comparator
Arm Description
The control group will receive a standard education brochure which will be provided pre-operatively to the participants.
Arm Title
Live education and exercise instruction
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Education brochure
Intervention Type
Other
Intervention Name(s)
Live education and exercise instruction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in score for Shoulder Pain and Disability Index (SPADI)
Description
Functional outcome measure questionnaire
Time Frame
Before sugery (range 0-4 weeks before surgery), 2 weeks post operatively and 6 weeks post-operatively
Secondary Outcome Measure Information:
Title
Change in Shoulder range of motion with goniometer
Time Frame
Pre-operatively (0-4 weeks pre-operatively), 2 and 6 weeks post-operatively
Other Pre-specified Outcome Measures:
Title
Change in other physical therapy test and measures
Description
6 minute walk test; presence of cording; number of patient reported medical complications; shoulder strength measured by a dynamometer; Arm lymphedema measured by volumeter; Anxiety, general functional abilities, and QOL will be measured by the Functional Assessment of Cancer Therapy- Breast Cancer (FACT-B); Patient satisfaction will be measured using a 5 point Likert Scale.
Time Frame
Once pre-operatively (0-4 weeks before surgery), 2 and 6 weeks after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Eve S Pepin, DPT
Organizational Affiliation
Oakland University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St-Mary's of Michigan
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
St. Mary's of Michigan
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effects of Pre-operative Physical Therapy Education
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