Breast Cancer Clinical Trial
Official title:
"Moving On" - A Randomized Controlled Trial for Acceptability and Feasibility of an Early Physical Therapy Education Intervention for Breast Cancer Surgical Candidates
NCT number | NCT04731805 |
Other study ID # | 12-04-17 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 23, 2012 |
Est. completion date | May 22, 2015 |
Verified date | January 2021 |
Source | Northeastern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | May 22, 2015 |
Est. primary completion date | May 22, 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 21 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Northeastern University | American Physical Therapy Association |
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. Review. — View 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. — View 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. — View Citation
Torres Lacomba M, Yuste Sánchez MJ, Zapico Goñi A, Prieto Merino D, Mayoral del Moral O, Cerezo Téllez E, Minayo Mogollón 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. — View 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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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