Breast Cancer Pre-habilitation and Prospective Surveillance to Prevent, Detect, and Optimize Physical and Function (B-PREPed)

A Randomized Pilot Test of the Breast Cancer Pre-habilitation and Prospective Surveillance to Prevent, Detect, and Optimize Physical and Functional Recovery

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: MOve-ABC; Other: Enhanced Usual Care

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Mitisha Shah, PT, MPH; Phone Number: 312-503-5638; Email: mitisha.shah@northwestern.edu
• Study Contact Backup: Name: Ann Marie Flores, PT, PhD, CLT; Email: ann.flores@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
      • Contact: Ann Marie Flores, PT, PhD, CLT; Email: ann.flores@northwestern.edu
      • Contact: Mitisha Shah, PT, MPH; Email: mitisha.shah@northwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with newly diagnosed Breast Cancer (BC) (stages 0-4) deemed eligible by the oncology physician team to undergo intent-to-cure treatment
• Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Scale score of 0 (Fully active, able to carry on all pre-disease performance without restriction), 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house- work, office work); or 2 (Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours)
• Patients must be Female [Note: Males are not included as BC in males is less than 1% of all cases]
• Patients must be English speaking
• Patients must be age ≥ 18 years
• Patients must have regular access to a mobile phone that can receive text messages and phone calls
• Patients must have the ability to understand and the willingness to sign a written informed consent document prior to registration on study

Exclusion Criteria:

• Patient with any prior malignancy (except non-melanoma skin)
• Patients with an ECOG Performance Scale score of 3 (Capable of only limited self-care; confined to bed or chair more than 50% of waking hours), 4 (Completely disabled; cannot carry on any self-care; totally confined to bed or chair) or 5 (dead)
• History of pre-existing upper extremity functional impairment, lymphedema, central nervous system damage, other systemic medical condition (e.g. fibromyalgia, rheumatoid arthritis, diabetes)
• Actively receiving physical therapy at the time of recruitment and baseline measurement
• Patients with brain metastasis with adverse events attributable to the metastasis ≥ grade 3
• Patients who are pregnant or lactating
• Patients with any issue that would limit their ability to comply with study requirements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Patients assigned to the intervention arm will receive the intervention named Moving On After Breast Cancer (MOve-ABC).	Other: MOve-ABC; The intervention is called Moving On After Breast Cancer (MOve-ABC) and includes: Three in-person visits for clinical measurements; Enhanced usual care (EUC); Pre-hab ((Pre-Treatment) PT evaluation and individualized home therapeutic exercise prescription with safe progressions).; Teach Back (HEP, post-op movement precautions); Self-management education with reinforcement check-ins via text messaging and phone calls at regular intervals.
Experimental: Enhanced Usual Care (EUC); All patients will receive EUC. However, participants assigned to this arm will have only EUC.	Other: Enhanced Usual Care; All patients will receive EUC. However, half of our sample will have only EUC consisting of; Three in-person visits for clinical measurements; Planned oncology treatment (surgery, chemotherapy, radiation); Nursing education on surgical site and drain care, post-operative movement precautions, pain management; If needed, laboratory and radiological testing to rule out disorders that interfere with treatment outcomes; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility in terms of percentage of participants completing the study protocol		Through study completion, an average of one year
Number of study participants with a score of less than 45 on the "Patient Reported Outcome Measurement Information System Physical Function Custom Form v2.0 Computerized Patient Reported Outcomes"	This questionnaire is a patient reported outcome measure to assess physical function status. The scores range from 23.9 to 58. Higher the score, higher is the physical function.	Baseline, Month 1, Month 2, Month 3, Month 4, Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average of all scores across the 6-items of Self-Efficacy for Managing Chronic Disease 6-Item (SEMCD-6) Scale	Scoring for each item is on a 1-10 scale where 1 is 'Not at all confident' and 10 is 'Totally Confident.' There are 6 such items. The scores of all the 6 items are combined and averaged to get the total score. The final score is between 1-10. Higher scores indicate higher self-efficacy.	Baseline, Month 3, Month 6

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Northwestern Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: October 4, 2023
• First Submitted That Met QC Criteria: October 9, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: STU00218105

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No