Moving On - An RCT to Test Physical Therapy Education

NCT04731805 | Completed

• 1 other identifier: 12-04-17
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Moving On After Breast Cancer - Intervention Arm

EXPERIMENTAL

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.

Behavioral: Moving On After Breast Cancer

Usual Care

NO INTERVENTION

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.

Interventions

Moving On After Breast Cancer BEHAVIORAL

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.

Also known as: Intervention arm

Moving On After Breast Cancer - Intervention Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northeastern University: lead
• American Physical Therapy Association: collaborator

Related Publications (5)

• Warren C. Physical therapy intervention suggestions for women following breast cancer surgery. Journal of Women's Health Physical Therapy. 2005;29(1):21-24.

  BACKGROUND

• 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.

  PMID: 19831159 BACKGROUND

• 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.

  PMID: 20556760 BACKGROUND

• 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.

  PMID: 20068255 BACKGROUND

• 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.

  PMID: 19675330 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ann M Flores, PhD

  Northeastern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized controlled trial, longitudinal and prospective

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: February 1, 2021
• Study Start: May 23, 2012
• Primary Completion: May 22, 2015
• Study Completion: May 22, 2015
• Last Updated: February 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share