Shoulder Rehabilitation Using a Mobile App Following Breast Reconstruction

November 28, 2023 updated by: Soo Kim, University of Saskatchewan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N2Z4
        • University of Saskatchewan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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).
Other: 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.
Experimental: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quick Disability of Arm, Shoulder and Hand (Quick DASH)
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).
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.
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)
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).
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).
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)
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).
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.
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)
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).
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.
At start of the study, at 4 weeks into the study and again at the end of the study (8 weeks into the study).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Saskatchewan

Collaborators

Royal University Hospital Foundation

Investigators

  • Principal Investigator: Soo Kim, PhD, University of Saskatchewan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2022

Primary Completion (Actual)

September 13, 2023

Study Completion (Actual)

September 13, 2023

Study Registration Dates

First Submitted

May 18, 2022

First Submitted That Met QC Criteria

May 18, 2022

First Posted (Actual)

May 24, 2022

Study Record Updates

Last Update Posted (Actual)

December 5, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Bio2738

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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