Early Rehabilitation for Breast Cancer - A Randomized Control Trial

Neoplasms, Breast Clinical Trial

Official title: Implementation of a Prospective Surveillance Rehabilitation Model for Women With Breast Cancer - A Randomized Controlled Trial

Status Terminated

Clinical Trial 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.

Clinical Trial 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.

If you are randomized into the intervention group, you will receive ~10 treatment visits with a licensed physical therapist. Scheduling will be at your convenience and based on what the physical therapist recommends. Those in the intervention group will receive individualized physical therapy treatments based on impairments identified. Treatment may include but is not limited to the following: passive, assisted and active ROM, manual therapy, soft tissue massage, myofascial release, therapeutic activities and exercise and patient education. Treatment duration and frequency will be specific to each patient, providing personalized care. Physical therapy intervention will occur 1-2x/week for 3-6 weeks beginning ~4 weeks after surgery (x̄=10 visits). Each visit will last ~60 minutes in duration.

The usual care groups will be instructed to continue with their typical daily activities.

All study participants will receive a handout containing education and home exercise instruction which is considered routine care.

Participants will receive a $25 gift card gift card for each completed in person assessment (baseline, 3 and 6 months post surgery) for a total of $75. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Neoplasms, Breast

• NCT number: NCT04777786
• Study type: Interventional
• Source: University of South Carolina
• Status: Terminated
• Phase: N/A
• Start date: April 1, 2021
• Completion date: March 31, 2023