MedTrace Logo

Early Rehabilitation for Breast Cancer - A Randomized Control Trial

NCT04777786 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2023-11-30

No results posted yet for this study

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.

Conditions

  • Neoplasms, Breast

Interventions

OTHER

Physical Therapy

Individualized physical therapy treatments will be provided based on impairments identified during assessments. 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. This type of intervention is considered a pragmatic approach, which will allow for generalization of the results due to the similarity with clinical practice.71 Pilot data indicates women will receive physical therapy intervention 1-2x/week for 3-6 weeks beginning \~4 weeks after surgery (x̄=10 visits).

Sponsors & Collaborators

  • Prisma Health-Midlands

    collaborator OTHER

  • University of South Carolina

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04777786 on ClinicalTrials.gov