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

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

NCT ID: NCT06081127

Condition: Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Pilot Randomized Controlled Trial

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: MOve-ABC
Description: 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.
Arm group label: Intervention

Intervention type: Other
Intervention name: Enhanced Usual Care
Description: 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
Arm group label: Enhanced Usual Care (EUC)

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.

Criteria for eligibility:
Criteria:
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

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Northwestern University

Address:
City: Chicago
Zip: 60611
Country: United States

Status: Recruiting

Contact:
Last name: Ann Marie Flores, PT, PhD, CLT
Email: ann.flores@northwestern.edu

Contact backup:
Last name: Mitisha Shah, PT, MPH
Email: mitisha.shah@northwestern.edu

Start date: November 20, 2023

Completion date: June 2024

Lead sponsor:
Agency: Northwestern University
Agency class: Other

Collaborator:
Agency: Northwestern Medicine
Agency class: Other

Source: Northwestern University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06081127