Implementation of a Prospective Surveillance Rehabilitation Model for Women With Breast Cancer - A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of South Carolina
- Enrollment
- 3
- Locations
- 2
- Primary Endpoint
- Change in Active range of motion
Study Overview
Brief Summary
Upper extremity strength, range of motion, activity limitations, fatigue and pain are well-documented concerns for women receiving treatment for breast cancer. Research has shown that cancer-related treatment side effects are amenable to rehabilitation interventions when identified early during treatment for breast cancer. Despite this, early rehabilitation has been reported in only 1-2% of individuals diagnosed with cancer. The Prospective Surveillance Model (PSM), a comprehensive model of survivorship care supported by the American Cancer Society and the National Cancer Institute, recommends a baseline assessment (near the time of diagnosis) and ongoing surveillance and intervention of impairments that minimize the impact of cancer treatments. A significant gap in knowledge currently exists with regards to the effectiveness of employing the PSM.
The purpose of this study is to examine the impact of implementing the PSM on impairments and functional limitations in women diagnosed with breast cancer during the first six months of treatment. A randomized controlled trial will be applied to examine a total of 28 women diagnosed with stage I-III breast cancer who will receive a mastectomy at Prisma Health in Columbia, S.C. Women will be randomized to one of two groups: PSM or usual care.
Detailed Description
The overall objective of this study is to examine the impact of employing early rehabilitation by implementing a randomized controlled trial at Prisma Health Midlands on women diagnosed with stage I-III breast cancer who will receive a mastectomy.
The following outcomes will be collected at 3-time points (baseline, 3 months and 6 months post-surgery)
- Objective measures: Upper extremity active range of motion, upper extremity, strength, physical function, and arm volume
- Patient reported (questionnaire) measures: Upper extremity function, functional mobility, balance, health-related quality f life, pain, fatigue, falls and distress.
The patient reported measures will also be collected electronically 24 hours after each of the 3 assessments (baseline, 3 months and 6 months post-surgery)
Each of the 3 study visits will last ~60 minutes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcomes assessors will be blinded to participant group allocation.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Eligible participants include adult female patients, ≥18 years of age, with a primary first-time diagnosis of breast cancer, and referred on or after January 1, 2021 for mastectomy surgery.
Exclusion Criteria
- •Women will be excluded if they will have bilateral surgery, breast-conserving surgery, recurrence of breast cancer, stage IV, or neoadjuvant treatment prior to surgery.
Outcomes
Primary Outcomes
Change in Active range of motion
Time Frame: Pre-surgery (baseline), 3- and 6-months post-surgery.
Active range of motion (AROM) will be measured in degrees. Measures will include shoulder flexion, external rotation at 90° of shoulder abduction, and shoulder abduction
Secondary Outcomes
- Upper extremity strength(Pre-surgery (baseline), 3- and 6-months post-surgery.)
- Pain interference(Pre-surgery (baseline), 3- and 6-months post-surgery. 24 hours after baseline assessment, 24 hours after 3-and 6-month post-surgery assessments)
- Balance(Pre-surgery (baseline), 3- and 6-months post-surgery.)
- Pain intensity(Pre-surgery (baseline), 3- and 6-months post-surgery. 24 hours after baseline assessment, 24 hours after 3-and 6-month post-surgery assessments)
- Arm volume(Pre-surgery (baseline), 3- and 6-months post-surgery.)
- 2-minute step test(Pre-surgery (baseline), 3- and 6-months post-surgery.)
- Timed arm curl(Pre-surgery (baseline), 3- and 6-months post-surgery.)
- Timed up and go(Pre-surgery (baseline), 3- and 6-months post-surgery.)
- 30 second sit to stand(Pre-surgery (baseline), 3- and 6-months post-surgery.)
- Health-Related Quality of Life(Pre-surgery (baseline), 3- and 6-months post-surgery. 24 hours after baseline assessment, 24 hours after 3-and 6-month post-surgery assessments)
- NCCN Distress Problem list(Pre-surgery (baseline), 3- and 6-months post-surgery. 24 hours after baseline assessment, 24 hours after 3-and 6-month post-surgery assessments)
- Fatigue(Pre-surgery (baseline), 3- and 6-months post-surgery. 24 hours after baseline assessment, 24 hours after 3-and 6-month post-surgery assessments)
- Falls(Pre-surgery (baseline), 3- and 6-months post-surgery.)
- NCCN Distress Thermometer(Pre-surgery (baseline), 3- and 6-months post-surgery. 24 hours after baseline assessment, 24 hours after 3-and 6-month post-surgery assessments)
- Upper Extremity Function(Pre-surgery (baseline), 3- and 6-months post-surgery.)
Investigators
Shana Harrington
Clinical Associate Professor
University of South Carolina