AzTrials
AzTrials

Shoulder DysfunctionNCT05388240

Shoulder Rehabilitation Using a Mobile App Following Breast Reconstruction

A study testing Education via a Mobile App and Education and Exercise via a Mobile App in people with Shoulder Dysfunction and Breast Reconstruction, run by University of Saskatchewan at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Shoulder Dysfunction, Breast Reconstruction
What is being tested?
Education via a Mobile App and Education and Exercise via a Mobile App
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteCanada
Study dates
28 Apr 2022to 13 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • minimum 18 years of age
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Saskatchewan

    Saskatoon, Saskatchewan, S7N2Z4

Other trials in Canada

About this study

Official title: Mobile App for Shoulder Rehabilitation Following Breast Reconstruction: A Pilot Study

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.

Read the detailed description

The percentage of Canadian women surviving at least 5 years beyond initial diagnosis is currently approaching 90% and many of these women are choosing to have breast reconstruction following mastectomy. Potential sequelae from both mastectomy and all types of breast reconstruction surgeries can result in various functional limitations. The most common adverse effect from breast cancer surgery is shoulder morbidity, having both short and long-term consequences for survivors, and evidence suggests women who undergo breast reconstruction are at even higher risk of developing shoulder problems. Shoulder/arm pain, reductions in strength, and limitations in range of motion (ROM) are some of the common physical issues plaguing BCS, often for years after the initial treatment. Fibrosis of the direct area of the target tissue is a common finding post radiation therapy, specifically of the anterior chest/ pectoralis and axilla regions in BCS and most noticeable starting six months post-surgically.

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.

Being tested
Education via a Mobile App, Education and Exercise via a Mobile App
Keywords
Mobile App

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Education via a Mobile AppOther

    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 AppOther

    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.

Study groups in NCT05388240
Study groupRoleWhat they receive
Education GroupActive comparatorThe 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).
Receives: Other: Education via a Mobile App
Education plus Exercise GroupExperimentalThe 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.
Receives: Other: Education and Exercise via a Mobile App

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Quick Disability of Arm, Shoulder and Hand (Quick DASH)

    The Quick DASH is an 11-item questionnaire measuring perceived upper extremity functional ability as well as symptoms on a 5-point scale from 1 (no difficulty) to 5 (unable) (Budtz, 2018). The Quick DASH is quick and easy to administer and to score, and has been used to measure shoulder function in the BCS population in previous studies (Chan et al., 2020; Duymaz et al., 2019; Lang et al., 2020). Data from this questionnaire will be used to better understand changes in upper extremity functional ability and symptoms from the start to end of intervention.

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

  2. Visual Analogue Scale (VAS)

    The VAS is a tool measuring intensity of symptoms from 0 (no pain) to 10 (worst pain). Each participant will be asked to rate their current shoulder pain on the continuum of this tool and this rating will be used to understand the level of shoulder pain of each participant on the day of assessment. Pain levels from start of intervention, to mid-intervention (at four weeks), to end of intervention (at eight weeks), will be analyzed using continuous ordinal regression or normal-distribution methods (t-test, linear regression) depending on the data collected, and to best understand significance of changes in pain levels from beginning to end of the intervention (Heller et al., 2016). Because of its simplicity and ease of use, it can be administered broadly across a wide variety of populations and can be presented in multiple ways, targeting certain populations of interest (Wewers et al., 1990).

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

  3. Fatigue Assessment Scale (FAS)

    The FAS is a 10-item questionnaire, that measures fatigue symptoms on a 5-point scale from "Never" (1) to "Always" (5). Although the development and use of most fatigue scales, including the FAS, have been disease specific, most often they have been developed to assess fatigue in people with cancer (Hjollund, 2007). The FAS will be analyzed similarly to the VAS to best understand significance of changes in fatigue levels from beginning to end of intervention.

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

  4. Short Form 36 (SF-36)

    The SF-36 is a 36-question survey aimed at measuring quality of life (QoL). This tool has been well researched and highly used in all populations, including healthy and disease specific populations (Ware et al., 1992), as well as in research (Ware et al., 1992; Lins et al., 2016). Reliability of the SF-36 is good for several diagnoses, including adult survivors of childhood cancer (Reulen, 2006). As the SF-36 measures both physical and mental health, research suggests its use in combination with other outcome measures when assessing overall QoL (Lins et al., 2016), hence the inclusion of other outcome measures as described above.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2022
  2. Study start28 Apr 2022
  3. Primary completion13 Sep 2023
  4. Study completion13 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized control trial; pilot study
Masking
Single blind
Who is masked
Investigator
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05388240
Sponsor's protocol ID
Bio2738
Status last verified
Nov 2023
First submitted
18 May 2022
Last updated
5 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23090185

  • 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.

    PubMed 27673514

  • 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.

    PubMed 19842790

  • 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.

    PubMed 30153282

  • 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.

    PubMed 28185324

  • 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.

    PubMed 31050088

  • 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.

    PubMed 15186323

  • 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.

    PubMed 16040476

  • 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.

    PubMed 30526622

  • 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.

    PubMed 32430021

  • 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.

    PubMed 31312791

  • 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.

    PubMed 28850536

  • 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.

    PubMed 17326844

Questions about this trial

What is this clinical trial studying?

A study testing Education via a Mobile App and Education and Exercise via a Mobile App in people with Shoulder Dysfunction and Breast Reconstruction, run by University of Saskatchewan at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Shoulder Range of Motion (ROM) (time frame: At start of the study, at 4 weeks into the study and again at the end of the study (8 weeks into the study).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05388240, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in