Shoulder Rehabilitation Using a Mobile App Following Breast Reconstruction

Status Completed

Clinical 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 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05388240
Study type	Interventional
Source	University of Saskatchewan
Contact
Status	Completed
Phase	N/A
Start date	April 28, 2022
Completion date	September 13, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03757793` - Near-infrared Spectroscopy for Monitoring Tissue Oxygenation in Breast Reconstruction
Completed	`NCT05491473` - Negative Pressure in PAP Donor Sites
Not yet recruiting	`NCT06013514` - Post-market Prospective Clinical Study of Nagor Perle Mammary Implants
Completed	`NCT02169011` - Secondary Breast Reconstruction With a Flap of Skin From the Back	N/A
Completed	`NCT01216319` - Evaluation of the Cook Biodesign Plastic Surgery Matrix	N/A
Completed	`NCT01176786` - Reusable Versus Disposable Draping System in Breast Reconstruction Surgery	N/A
Not yet recruiting	`NCT00973544` - Do Closed Suction Drains Affect the Complications Rate of Breast Reconstruction With Silicone Prosthesis?	N/A
Active, not recruiting	`NCT00748722` - Pre-Operative Imaging of Abdominal Wall Perforators Using CT Angiography	N/A
Completed	`NCT00753922` - Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses	Phase 3
Completed	`NCT05897463` - Nipple Neurotization
Recruiting	`NCT05377723` - Abdominal Scar Improvement in Microsurgical Breast Reconstruction	N/A
Completed	`NCT04350411` - Comparison of PEAK PlasmaBlade™ to Conventional Diathermy in Abdominal Based Free Flap Breast Reconstruction	N/A
Completed	`NCT06321549` - New Era of DIEP With Minimally Invasive Mastectomy
Withdrawn	`NCT03135392` - Sensation After Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer	N/A
Completed	`NCT01256502` - The SERI® Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery	N/A
Active, not recruiting	`NCT04715802` - Options on the Breast Reconstruction Timing and Method After Removal of Polyacrylamide Hydrogel
Active, not recruiting	`NCT04491591` - Implementing BREASTChoice Into Practice	N/A
Recruiting	`NCT04661501` - BREAST ADM Trial for Alloplastic Breast Reconstruction	N/A
Suspended	`NCT03625765` - Integrated Imaging System for In Vivo Visualization of Free Flap Perfusion Using Indocyanine Dye	N/A
Withdrawn	`NCT00778947` - Single Centre Study to Compare Harmonic Scalpel to Conventional Diathermy in Free Tissue Transfer Breast Reconstruction	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.