Clinical trial NCT05388240: Shoulder Rehabilitation Using a Mobile App Following Breast Reconstruction
Official title: Mobile App for Shoulder Rehabilitation Following Breast Reconstruction: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Dysfunction
Breast Reconstruction
Keywords: Mobile App
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Royal University Hospital Foundation
First posted: 2022-05-24
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial; pilot study
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Shoulder Range of Motion (ROM)
timeFrame: 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:
measure: Quick Disability of Arm, Shoulder and Hand (Quick DASH)
timeFrame: At start of the study, at 4 weeks into the study and again at the end of the study (8 weeks into the study).
measure: Visual Analogue Scale (VAS)
timeFrame: At start of the study, at 4 weeks into the study and again at the end of the study (8 weeks into the study).
measure: Fatigue Assessment Scale (FAS)
timeFrame: At start of the study, at 4 weeks into the study and again at the end of the study (8 weeks into the study).
measure: Short Form 36 (SF-36)
timeFrame: At start of the study, at 4 weeks into the study and again at the end of the study (8 weeks into the study).
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Soo Kim, PhD
role: PRINCIPAL_INVESTIGATOR
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