Back to resultsMoving On - An RCT to Test Physical Therapy Education
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Moving On After Breast Cancer
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer
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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Moving On After Breast Cancer - Intervention Arm
Usual Care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04731805
First Posted
January 24, 2021
Last Updated
January 28, 2021
Sponsor
Northeastern University
Collaborators
American Physical Therapy Association
1. Study Identification
Unique Protocol Identification Number
NCT04731805
Brief Title
Moving On - An RCT to Test Physical Therapy Education
Official Title
"Moving On" - A Randomized Controlled Trial for Acceptability and Feasibility of an Early Physical Therapy Education Intervention for Breast Cancer Surgical Candidates
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 23, 2012 (Actual)
Primary Completion Date
May 22, 2015 (Actual)
Study Completion Date
May 22, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northeastern University
Collaborators
American Physical Therapy Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial, longitudinal and prospective
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Moving On After Breast Cancer - Intervention Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Moving On After Breast Cancer
Other Intervention Name(s)
Intervention arm
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in active shoulder range of motion
Description
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.
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann M Flores, PhD
Organizational Affiliation
Northeastern University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Warren C. Physical therapy intervention suggestions for women following breast cancer surgery. Journal of Women's Health Physical Therapy. 2005;29(1):21-24.
Results Reference
background
PubMed Identifier
19831159
Citation
Mustian KM, Peppone L, Darling TV, Palesh O, Heckler CE, Morrow GR. A 4-week home-based aerobic and resistance exercise program during radiation therapy: a pilot randomized clinical trial. J Support Oncol. 2009 Sep-Oct;7(5):158-67.
Results Reference
background
PubMed Identifier
20556760
Citation
McNeely ML, Campbell K, Ospina M, Rowe BH, Dabbs K, Klassen TP, Mackey J, Courneya K. Exercise interventions for upper-limb dysfunction due to breast cancer treatment. Cochrane Database Syst Rev. 2010 Jun 16;(6):CD005211. doi: 10.1002/14651858.CD005211.pub2.
Results Reference
background
PubMed Identifier
20068255
Citation
Torres Lacomba M, Yuste Sanchez MJ, Zapico Goni A, Prieto Merino D, Mayoral del Moral O, Cerezo Tellez E, Minayo Mogollon E. Effectiveness of early physiotherapy to prevent lymphoedema after surgery for breast cancer: randomised, single blinded, clinical trial. BMJ. 2010 Jan 12;340:b5396. doi: 10.1136/bmj.b5396.
Results Reference
background
PubMed Identifier
19675330
Citation
Schmitz KH, Ahmed RL, Troxel A, Cheville A, Smith R, Lewis-Grant L, Bryan CJ, Williams-Smith CT, Greene QP. Weight lifting in women with breast-cancer-related lymphedema. N Engl J Med. 2009 Aug 13;361(7):664-73. doi: 10.1056/NEJMoa0810118.
Results Reference
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Moving On - An RCT to Test Physical Therapy Education
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