Shoulder Rehabilitation Using a Mobile App Following Breast Reconstruction
NCT ID: NCT05388240
Last Updated: 2023-12-05
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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COMPLETED
NA
22 participants
INTERVENTIONAL
2022-04-28
2023-09-13
Brief Summary
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Detailed Description
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The researchers' interest in the feasibility of a shoulder rehabilitation mobile app for post-surgical BCS is to improve access to rehabilitation (including education, exercises, and remote support with a physical therapist, PT) for these women, allowing for better functional outcomes which could translate into decreased reliance on medical care, improved quality of life (QoL), and ability to participate in life roles.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Education Group
The Education Group will be provided with standard education by the physiotherapist at the hospital prior to surgery and will be advised to continue with their normal activities of daily living (ADL). They will have access to the "standard education and resources" tabs on the mobile app. Shoulder specific exercises tab on the app will be available to them upon their completion of the study (eight weeks post-intervention).
Education via a Mobile App
This group will have access to "Education and Resources" tab that includes customary information given at a pre-op appointment plus some additional related education and resources.
Education plus Exercise Group
The Exercise plus Education Group will be provided with standard education by the physiotherapist at the hospital prior to surgery. Participants in this group will have access to the "education and resources" tabs on the app.
Education and Exercise via a Mobile App
This group will have access to "Education and Resources" tab that includes customary information given at a pre-op appointment plus some additional related education and resources. The app will also be used to help guide participants through an eight-week shoulder exercise program, together with physical therapy remote support.
Interventions
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Education via a Mobile App
This group will have access to "Education and Resources" tab that includes customary information given at a pre-op appointment plus some additional related education and resources.
Education and Exercise via a Mobile App
This group will have access to "Education and Resources" tab that includes customary information given at a pre-op appointment plus some additional related education and resources. The app will also be used to help guide participants through an eight-week shoulder exercise program, together with physical therapy remote support.
Eligibility Criteria
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Inclusion Criteria
* scheduled for immediate or delayed breast reconstruction (implant type only)
* 6 weeks or less from time of surgery
* must have mobile phone capable of app download
* need desk top or laptop computer for Zoom meetings
* medically stable
* able to be informed and consent in English
Exclusion Criteria
* lack of access to a mobile phone and laptop or desk top computer for Zoom meetings
* inability to comprehend the English language
18 Years
FEMALE
No
Sponsors
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Royal University Hospital Foundation
OTHER
University of Saskatchewan
OTHER
Responsible Party
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Soo Kim
Associate Professor
Principal Investigators
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Soo Kim, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Saskatchewan
Locations
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University of Saskatchewan
Saskatoon, Saskatchewan, Canada
Countries
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References
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Canadian Cancer Statistics 2019. Toronto, ON. (2019). Retrieved November 30, 2020 from http://www.cancer.ca/~/media/cancer.ca/CW/cancer information/cancer 101/Canadian cancer statistics/Canadian-Cancer-Statistics 2019-EN.pdf?la=en.
Ditsch N, Bauerfeind I, Vodermaier A, Tripp C, Lohrs B, Toth B, Himsl I, Graeser M, Harbeck N, Lenhard M. A retrospective investigation of women's experience with breast reconstruction after mastectomy. Arch Gynecol Obstet. 2013 Mar;287(3):555-61. doi: 10.1007/s00404-012-2590-1. Epub 2012 Oct 23.
Zhong T, Hu J, Bagher S, Vo A, O'Neill AC, Butler K, Novak CB, Hofer SOP, Metcalfe KA. A Comparison of Psychological Response, Body Image, Sexuality, and Quality of Life between Immediate and Delayed Autologous Tissue Breast Reconstruction: A Prospective Long-Term Outcome Study. Plast Reconstr Surg. 2016 Oct;138(4):772-780. doi: 10.1097/PRS.0000000000002536.
Nesvold IL, Fossa SD, Holm I, Naume B, Dahl AA. Arm/shoulder problems in breast cancer survivors are associated with reduced health and poorer physical quality of life. Acta Oncol. 2010 Apr;49(3):347-53. doi: 10.3109/02841860903302905.
Blackburn NE, Mc Veigh JG, Mc Caughan EM, Kennedy RD, McIntosh SA, Wilson IM. The musculoskeletal consequences of latissmus dorsi breast reconstruction in women following mastectomy for breast cancer. PLoS One. 2018 Aug 28;13(8):e0202859. doi: 10.1371/journal.pone.0202859. eCollection 2018.
Blackburn NE, Mc Veigh JG, Mc Caughan E, Wilson IM. The musculoskeletal consequences of breast reconstruction using the latissimus dorsi muscle for women following mastectomy for breast cancer: A critical review. Eur J Cancer Care (Engl). 2018 Mar;27(2):e12664. doi: 10.1111/ecc.12664. Epub 2017 Feb 10.
Verbelen H, Tjalma W, Meirte J, Gebruers N. Long-term morbidity after a negative sentinel node in breast cancer patients. Eur J Cancer Care (Engl). 2019 Sep;28(5):e13077. doi: 10.1111/ecc.13077. Epub 2019 May 3.
Riekki R, Harvima IT, Jukkola A, Risteli J, Oikarinen A. The production of collagen and the activity of mast-cell chymase increase in human skin after irradiation therapy. Exp Dermatol. 2004 Jun;13(6):364-71. doi: 10.1111/j.0906-6705.2004.00164.x.
Karki A, Simonen R, Malkia E, Selfe J. Impairments, activity limitations and participation restrictions 6 and 12 months after breast cancer operation. J Rehabil Med. 2005 May;37(3):180-8. doi: 10.1080/16501970410024181.
Budtz CR, Andersen JH, de Vos Andersen NB, Christiansen DH. Responsiveness and minimal important change for the quick-DASH in patients with shoulder disorders. Health Qual Life Outcomes. 2018 Dec 10;16(1):226. doi: 10.1186/s12955-018-1052-2.
Chan KS, Zeng D, Leung JHT, Ooi BSY, Kong KT, Yeo YH, Goo JTT, Chia CLK. Measuring upper limb function and patient reported outcomes after major breast cancer surgery: a pilot study in an Asian cohort. BMC Surg. 2020 May 19;20(1):108. doi: 10.1186/s12893-020-00773-0.
Duymaz T, Iyigun ZE, Ilgun AS, Ordu C, Ucuncu M, Alco G, Ozturk A, Elbuken F, Aktepe F, Ozmen V. The Effect of Mini-Latissimus Dorsi Flap (MLDF) Reconstruction on Shoulder Function in Breast Cancer Patients. Eur J Breast Health. 2019 Jul 1;15(3):158-162. doi: 10.5152/ejbh.2019.4727. eCollection 2019 Jul.
Lang, A. (2020). Towards Improving Clinical Evaluation of the Shoulder: Defining Upper Limb Biomechanics of Breast Cancer Survivors During Functional Evaluation Tasks (Doctoral Dissertation). University of Saskatchewan.
Heller GZ, Manuguerra M, Chow R. How to analyze the Visual Analogue Scale: Myths, truths and clinical relevance. Scand J Pain. 2016 Oct;13:67-75. doi: 10.1016/j.sjpain.2016.06.012. Epub 2016 Jul 27.
Hjollund NH, Andersen JH, Bech P. Assessment of fatigue in chronic disease: a bibliographic study of fatigue measurement scales. Health Qual Life Outcomes. 2007 Feb 27;5:12. doi: 10.1186/1477-7525-5-12.
Lins L, Carvalho FM. SF-36 total score as a single measure of health-related quality of life: Scoping review. SAGE Open Med. 2016 Oct 4;4:2050312116671725. doi: 10.1177/2050312116671725. eCollection 2016.
Reulen RC, Zeegers MP, Jenkinson C, Lancashire ER, Winter DL, Jenney ME, Hawkins MM. The use of the SF-36 questionnaire in adult survivors of childhood cancer: evaluation of data quality, score reliability, and scaling assumptions. Health Qual Life Outcomes. 2006 Oct 5;4:77. doi: 10.1186/1477-7525-4-77.
Lee, S. (2021). Breast cancer statistics. Canadian Cancer Society. Retrieved March 9, 2022, from https://cancer.ca/en/cancer-information/cancer-types/breast/statistics
Plastic surgery statistics. American Society of Plastic Surgeons. (2020). Retrieved March 9, 2022, from https://www.plasticsurgery.org/news/plastic-surgery-statistics
Ware, J. E. (1993, January). SF-36 Health Survey: Manual & Interpretation Guide. ResearchGate. https://www.researchgate.net/publication/313050850_SF-36_Health_Survey_Manual_Interpretation_Guide
Other Identifiers
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Bio2738
Identifier Type: -
Identifier Source: org_study_id