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

NCT06081127 | Completed

• 1 other identifier: STU00218105
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Average of all scores across the 6-items of Self-Efficacy for Managing Chronic Disease 6-Item (SEMCD-6) Scale

  Baseline, Month 3, Month 6

Study Arms (2)

Intervention

EXPERIMENTAL

Patients assigned to the intervention arm will receive the intervention named Moving On After Breast Cancer (MOve-ABC).

Other: MOve-ABC

Enhanced Usual Care (EUC)

EXPERIMENTAL

All patients will receive EUC. However, participants assigned to this arm will have only EUC.

Other: Enhanced Usual Care

Interventions

MOve-ABC OTHER

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.

Intervention

Enhanced Usual Care OTHER

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

Enhanced Usual Care (EUC)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Northwestern Medicine: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ann Marie Flores, PT, MSPT, MA, PhD, CLT

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Pilot Randomized Controlled Trial

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 13, 2023
• Study Start: November 20, 2023
• Primary Completion: May 13, 2025
• Study Completion: May 13, 2025
• Last Updated: December 30, 2025

Record last verified: 2025-02

Locations

US (1)