Early Rehabilitation for Breast Cancer - A Randomized Control Trial
NCT ID: NCT04777786
Last Updated: 2023-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
3 participants
INTERVENTIONAL
2021-04-01
2023-03-31
Brief Summary
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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.
Detailed Description
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The following outcomes will be collected at 3-time points (baseline, 3 months and 6 months post-surgery)
* Objective measures: Upper extremity active range of motion, upper extremity, strength, physical function, and arm volume
* Patient reported (questionnaire) measures: Upper extremity function, functional mobility, balance, health-related quality f life, pain, fatigue, falls and distress.
The patient reported measures will also be collected electronically 24 hours after each of the 3 assessments (baseline, 3 months and 6 months post-surgery)
Each of the 3 study visits will last \~60 minutes.
If you are randomized into the intervention group, you will receive \~10 treatment visits with a licensed physical therapist. Scheduling will be at your convenience and based on what the physical therapist recommends. Those in the intervention group will receive individualized physical therapy treatments based on impairments identified. 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. Physical therapy intervention will occur 1-2x/week for 3-6 weeks beginning \~4 weeks after surgery (x̄=10 visits). Each visit will last \~60 minutes in duration.
The usual care groups will be instructed to continue with their typical daily activities.
All study participants will receive a handout containing education and home exercise instruction which is considered routine care.
Participants will receive a $25 gift card gift card for each completed in person assessment (baseline, 3 and 6 months post surgery) for a total of $75.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Physical Therapy Intervention
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
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).
Usual Care
The usual care group will be instructed to continue with their typical daily activities.
No interventions assigned to this group
Interventions
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Physical Therapy
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).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Prisma Health-Midlands
OTHER
University of South Carolina
OTHER
Responsible Party
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Shana Harrington
Clinical Associate Professor
Locations
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University of South Carolina
Columbia, South Carolina, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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115300-20-52703
Identifier Type: -
Identifier Source: org_study_id