Early Rehabilitation for Breast Cancer - A Randomized Control Trial

NCT04777786 | Terminated

• 1 other identifier: 115300-20-52703
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Upper extremity strength, range of motion, activity limitations, fatigue and pain are well-documented concerns for women receiving treatment for breast cancer. Research has shown that cancer-related treatment side effects are amenable to rehabilitation interventions when identified early during treatment for breast cancer. Despite this, early rehabilitation has been reported in only 1-2% of individuals diagnosed with cancer. The Prospective Surveillance Model (PSM), a comprehensive model of survivorship care supported by the American Cancer Society and the National Cancer Institute, recommends a baseline assessment (near the time of diagnosis) and ongoing surveillance and intervention of impairments that minimize the impact of cancer treatments. A significant gap in knowledge currently exists with regards to the effectiveness of employing the PSM. The purpose of this study is to examine the impact of implementing the PSM on impairments and functional limitations in women diagnosed with breast cancer during the first six months of treatment. A randomized controlled trial will be applied to examine a total of 28 women diagnosed with stage I-III breast cancer who will receive a mastectomy at Prisma Health in Columbia, S.C. Women will be randomized to one of two groups: PSM or usual care.

Conditions

Neoplasms, Breast

Outcome Measures

Primary Outcomes (1)

• Change in Active range of motion

  Active range of motion (AROM) will be measured in degrees. Measures will include shoulder flexion, external rotation at 90° of shoulder abduction, and shoulder abduction

  Pre-surgery (baseline), 3- and 6-months post-surgery.

Secondary Outcomes (16)

• Upper extremity strength

  Pre-surgery (baseline), 3- and 6-months post-surgery.

• Upper Extremity Function

  Pre-surgery (baseline), 3- and 6-months post-surgery.

• Upper Extremity Function

  Pre-surgery (baseline), 3- and 6-months post-surgery.

• Balance

  Pre-surgery (baseline), 3- and 6-months post-surgery.

• Health-Related Quality of Life

  Pre-surgery (baseline), 3- and 6-months post-surgery. 24 hours after baseline assessment, 24 hours after 3-and 6-month post-surgery assessments

Study Arms (2)

Physical Therapy Intervention

EXPERIMENTAL

Individualized physical therapy treatments will be provided based on impairments identified during assessments. Treatment may include but is not limited to the following: passive, assisted and active ROM, manual therapy, soft tissue massage, myofascial release, therapeutic activities and exercise and patient education. Treatment duration and frequency will be specific to each patient, providing personalized care. This type of intervention is considered a pragmatic approach, which will allow for generalization of the results due to the similarity with clinical practice.71 Pilot data indicates women will receive physical therapy intervention 1-2x/week for 3-6 weeks beginning \~4 weeks after surgery (x̄=10 visits).

Other: Physical Therapy

Usual Care

NO INTERVENTION

The usual care group will be instructed to continue with their typical daily activities.

Interventions

Physical Therapy OTHER

Individualized physical therapy treatments will be provided based on impairments identified during assessments. Treatment may include but is not limited to the following: passive, assisted and active ROM, manual therapy, soft tissue massage, myofascial release, therapeutic activities and exercise and patient education. Treatment duration and frequency will be specific to each patient, providing personalized care. This type of intervention is considered a pragmatic approach, which will allow for generalization of the results due to the similarity with clinical practice.71 Pilot data indicates women will receive physical therapy intervention 1-2x/week for 3-6 weeks beginning \~4 weeks after surgery (x̄=10 visits).

Physical Therapy Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Females with breast cancer are the population of interest.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible participants include adult female patients, ≥18 years of age, with a primary first-time diagnosis of breast cancer, and referred on or after January 1, 2021 for mastectomy surgery.

You may not qualify if:

• Women will be excluded if they will have bilateral surgery, breast-conserving surgery, recurrence of breast cancer, stage IV, or neoadjuvant treatment prior to surgery.

Sponsors & Collaborators

• University of South Carolina: lead
• Prisma Health-Midlands: collaborator

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Related Publications (7)

• Harrington S, Padua D, Battaglini C, Michener LA, Giuliani C, Myers J, Groff D. Comparison of shoulder flexibility, strength, and function between breast cancer survivors and healthy participants. J Cancer Surviv. 2011 Jun;5(2):167-74. doi: 10.1007/s11764-010-0168-0. Epub 2011 Jan 12.

  PMID: 21225372 BACKGROUND

• Becker, A.M., Vanlandingham, S., Grogan, M.M., McGowan, M.H., Harrington, S.E. (2019) Impact of Early Rehabilitation in Women Actively Receiving Treatment for Breast Cancer. Rehabilitation Oncology. 38(1): E20, January 2020.

  BACKGROUND

• Harrington SE, Stout NL, Hile E, Fisher MI, Eden M, Marchese V, Pfalzer LA. Cancer Rehabilitation Publications (2008-2018) With a Focus on Physical Function: A Scoping Review. Phys Ther. 2020 Mar 10;100(3):363-415. doi: 10.1093/ptj/pzz184.

  PMID: 32043151 BACKGROUND

• Stout NL, Binkley JM, Schmitz KH, Andrews K, Hayes SC, Campbell KL, McNeely ML, Soballe PW, Berger AM, Cheville AL, Fabian C, Gerber LH, Harris SR, Johansson K, Pusic AL, Prosnitz RG, Smith RA. A prospective surveillance model for rehabilitation for women with breast cancer. Cancer. 2012 Apr 15;118(8 Suppl):2191-200. doi: 10.1002/cncr.27476.

  PMID: 22488693 BACKGROUND

• Stout NL, Silver JK, Raj VS, Rowland J, Gerber L, Cheville A, Ness KK, Radomski M, Nitkin R, Stubblefield MD, Morris GS, Acevedo A, Brandon Z, Braveman B, Cunningham S, Gilchrist L, Jones L, Padgett L, Wolf T, Winters-Stone K, Campbell G, Hendricks J, Perkin K, Chan L. Toward a National Initiative in Cancer Rehabilitation: Recommendations From a Subject Matter Expert Group. Arch Phys Med Rehabil. 2016 Nov;97(11):2006-2015. doi: 10.1016/j.apmr.2016.05.002. Epub 2016 May 27.

  PMID: 27237580 BACKGROUND

• Schmitz KH, Stout NL, Andrews K, Binkley JM, Smith RA. Prospective evaluation of physical rehabilitation needs in breast cancer survivors: a call to action. Cancer. 2012 Apr 15;118(8 Suppl):2187-90. doi: 10.1002/cncr.27471. No abstract available.

  PMID: 22488692 BACKGROUND

• Stout NL, Andrews K, Binkley JM, Schmitz KH, Smith RA. Stakeholder perspectives on dissemination and implementation of a prospective surveillance model of rehabilitation for breast cancer treatment. Cancer. 2012 Apr 15;118(8 Suppl):2331-4. doi: 10.1002/cncr.27470.

  PMID: 22488707 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors will be blinded to participant group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Randomized clinical trial design

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: March 2, 2021
• Study Start: April 1, 2021
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)