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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Illinois
Northwestern University
RECRUITING
Chicago
Contact Information
Primary
Bridget Groble, BS
bridget.groble@northwestern.edu
312-503-5067
Backup
Ann Marie Flores, PT, PhD, CLT
ann.flores@northwestern.edu
Time Frame
Start Date: 2023-11-20
Estimated Completion Date: 2025-06
Participants
Target number of participants: 75
Treatments
Experimental: Intervention
Patients assigned to the intervention arm will receive the intervention named Moving On After Breast Cancer (MOve-ABC).
Experimental: Enhanced Usual Care (EUC)
All patients will receive EUC. However, participants assigned to this arm will have only EUC.
Related Therapeutic Areas
Sponsors
Collaborators: Northwestern Medicine
Leads: Northwestern University

This content was sourced from clinicaltrials.gov

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