Breast Cancer Pre-habilitation and Prospective Surveillance to Prevent, Detect, and Optimize Physical and Function

Summary

The goal of this research study is to determine the feasibility and potential effects of physical therapy and enhanced patient education delivered before breast cancer treatment. Physical therapy before cancer treatment aims to help with early identification and self-management of physical and functional side effects from cancer treatment. Side effects could be joint pain, muscle weakness, or fatigue that contribute to functional impairment.

The main questions this study aims to answer are:

1. Determine the feasibility (acceptability and suitability) and potential effects of an early intervention called 'Moving On-After Breast Cancer' (MOve-ABC) on physical and functional side effects of cancer compared to enhanced usual care in a large academic medical system to help us refine and adjust the intervention in preparation for a large randomized, double-blinded, controlled trial.
2. Determine whether MOve-ABC also affects patient self-management and provider knowledge and behaviors related to detection and management of physical and functional effects associated with cancer.

Participants will be randomly assigned to either of the two arms of the study which are 'Intervention' and 'Enhanced usual care.'

Participants in the intervention arm will receive:

1\. Planned care per their oncology physician team plus: 1.1. Patient education on physical function in breast cancer 1.2. Physical therapy evaluation 1.3. Individualized home exercise prescription 1.4. Education materials in the form of a study booklet, study website, text messaging, and phone calls 1.5. Monthly monitoring of physical and functional survey scores to identify the need for physical therapy and provide referrals as needed

Participants in the enhanced usual care arm will receive:

1\. Planned care per their oncology physician team plus 1.2. Monthly monitoring of their physical functional scores to identify the need for physical therapy and provide referrals as needed

All participants will attend three in-person visits for clinical measurements.

Conditions

• Breast Cancer

Interventions

OTHER

MOve-ABC

The intervention is called Moving On After Breast Cancer (MOve-ABC) and includes: 1. Three in-person visits for clinical measurements 2. Enhanced usual care (EUC) 3. Pre-hab (Pre-Treatment (PT) evaluation and individualized home therapeutic exercise prescription with safe progressions). 4. Teach Back (HEP, post-op movement precautions) 5. Self-management education with reinforcement check-ins via text messaging and phone calls at regular intervals.

OTHER

Enhanced Usual Care

All patients will receive EUC. However, half of our sample will have only EUC consisting of 1. Three in-person visits for clinical measurements 2. Planned oncology treatment (surgery, chemotherapy, radiation) 3. Nursing education on surgical site and drain care, post-operative movement precautions, pain management 4. If needed, laboratory and radiological testing to rule out disorders that interfere with treatment outcomes 5. Monthly monitoring with Patient-Reported Outcomes Measurement Information System - Physical Function (PROMIS-PF) surveys beginning at baseline with alerts from scores = or \< 45 (indicating moderate or severe impairment) for physical therapy referral

Sponsors & Collaborators

• Northwestern Medicine

  collaborator OTHER

• Northwestern University

  lead OTHER

Principal Investigators

• Ann Marie Flores, PT, MSPT, MA, PhD, CLT · Northwestern University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-20

Primary Completion

2025-05-13

Completion

2025-05-13

Countries

• United States

Study Locations