Clinical trial NCT04731805: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Northeastern University
Sponsor class: OTHER
Collaborators: name: American Physical Therapy Association
First posted: 2021-02-01
Enrollment: 50
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial, longitudinal and prospective
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in active shoulder range of motion
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Northeastern University
name: Ann M Flores, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.