Shoulder Rehabilitation Using a Mobile App Following Breast Reconstruction

NCT05388240 | Completed

• 1 other identifier: Bio2738
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is the most common cancer for Canadian women. Of the women who will have a mastectomy each year in Canada, one in five will elect to have breast reconstruction. However, the significant benefits for body-image, self-esteem, sexuality, and quality of life are tempered by post-treatment shoulder dysfunction for many. As a means to decrease shoulder morbidities in breast cancer survivors (BCS), this study will introduce a mobile application (app)-based shoulder rehabilitation program as an option to improve functional outcomes of the shoulder, for those who have had breast reconstruction.

Conditions

Shoulder Dysfunction; Breast Reconstruction

Keywords

Mobile App

Outcome Measures

Primary Outcomes (1)

• Shoulder Range of Motion (ROM)

  ROM measurements of both shoulders (flexion, extension, abduction, internal and external rotation) will be taken post-operatively, via the downloaded app on each participant's phone, and by visual examination of the research assistant (registered, licensed PT) during the virtual assessment via Zoom. These ROM measures, taken at the beginning of the intervention (week one), mid-intervention (week four), and end of intervention (week eight) will be used as a guide for exercise progression throughout the intervention. The measurements will also be used in our data analysis to understand changes in shoulder ROM from the beginning of the intervention to the end of intervention.

  At start of the study, at 4 weeks into the study and again at the end of the study (8 weeks into the study).

Secondary Outcomes (4)

• Quick Disability of Arm, Shoulder and Hand (Quick DASH)

  At start of the study, at 4 weeks into the study and again at the end of the study (8 weeks into the study).

• Visual Analogue Scale (VAS)

  At start of the study, at 4 weeks into the study and again at the end of the study (8 weeks into the study).

• Fatigue Assessment Scale (FAS)

  At start of the study, at 4 weeks into the study and again at the end of the study (8 weeks into the study).

• Short Form 36 (SF-36)

  At start of the study, at 4 weeks into the study and again at the end of the study (8 weeks into the study).

Study Arms (2)

Education Group

ACTIVE COMPARATOR

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).

Other: Education via a Mobile App

Education plus Exercise Group

EXPERIMENTAL

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.

Other: Education and Exercise via a Mobile App

Interventions

Education via a Mobile App OTHER

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 Group

Education and Exercise via a Mobile App OTHER

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.

Education plus Exercise Group

Eligibility Criteria

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

You may qualify if:

• minimum 18 years of age
• scheduled for immediate or delayed breast reconstruction (implant type only)
• 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

You may not qualify if:

• ongoing or current health-related issues that would interfere with the ability to complete the program (i.e. metastatic cancer, severe cardiovascular disease)
• lack of access to a mobile phone and laptop or desk top computer for Zoom meetings
• inability to comprehend the English language

Sponsors & Collaborators

• University of Saskatchewan: lead
• Royal University Hospital Foundation: collaborator

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N2Z4, Canada

Location

Related Publications (20)

• 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.

  BACKGROUND

• 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.

  PMID: 23090185 BACKGROUND

• 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.

  PMID: 27673514 BACKGROUND

• 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.

  PMID: 19842790 BACKGROUND

• 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.

  PMID: 30153282 BACKGROUND

• 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.

  PMID: 28185324 BACKGROUND

• 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.

  PMID: 31050088 BACKGROUND

• 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.

  PMID: 15186323 BACKGROUND

• 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.

  PMID: 16040476 BACKGROUND

• 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.

  PMID: 30526622 BACKGROUND

• 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.

  PMID: 32430021 BACKGROUND

• 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.

  PMID: 31312791 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 28850536 BACKGROUND

• 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.

  PMID: 17326844 BACKGROUND

• 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.

  PMID: 27757230 BACKGROUND

• 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.

  PMID: 17022814 BACKGROUND

• Lee, S. (2021). Breast cancer statistics. Canadian Cancer Society. Retrieved March 9, 2022, from https://cancer.ca/en/cancer-information/cancer-types/breast/statistics

  BACKGROUND

• Plastic surgery statistics. American Society of Plastic Surgeons. (2020). Retrieved March 9, 2022, from https://www.plasticsurgery.org/news/plastic-surgery-statistics

  BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Soo Kim, PhD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized control trial; pilot study

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 24, 2022
• Study Start: April 28, 2022
• Primary Completion: September 13, 2023
• Study Completion: September 13, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)