Clinical Trials Directory

Trials / Completed

CompletedNCT05388240

Shoulder Rehabilitation Using a Mobile App Following Breast Reconstruction

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
22 (actual)
Sponsor
University of Saskatchewan · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
OTHEREducation via a Mobile AppThis 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.
OTHEREducation and Exercise via a Mobile AppThis 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.

Timeline

Start date
2022-04-28
Primary completion
2023-09-13
Completion
2023-09-13
First posted
2022-05-24
Last updated
2023-12-05

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT05388240. Inclusion in this directory is not an endorsement.