Moving On - An RCT to Test Physical Therapy Education

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04731805
• Other study ID #: 12-04-17
• Status: Completed
• Phase: N/A
• Start date: May 23, 2012
• Est. completion date: May 22, 2015

Study information

• Verified date: January 2021
• Source: Northeastern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Moving On After Breast Cancer
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Northeastern University	American Physical Therapy Association

References & Publications (5)

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.

Outcome

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