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

Primary Purpose

Breast Cancer

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MOve-ABC
Enhanced Usual Care
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 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

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention

Enhanced Usual Care (EUC)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Feasibility in terms of percentage of participants completing the study protocol
Number of study participants with a score of less than 45 on the cPRO Physical Function 2-item Questionnaire
Patient reported outcome measure to assess physical function status

Secondary Outcome Measures

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.

Full Information

First Posted
October 4, 2023
Last Updated
October 9, 2023
Sponsor
Northwestern University
Collaborators
Northwestern Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT06081127
Brief Title
Breast Cancer Pre-habilitation and Prospective Surveillance to Prevent, Detect, and Optimize Physical and Function
Acronym
B-PREPed
Official Title
A Randomized Pilot Test of the Breast Cancer Pre-habilitation and Prospective Surveillance to Prevent, Detect, and Optimize Physical and Functional Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Northwestern Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Pilot Randomized Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients assigned to the intervention arm will receive the intervention named Moving On After Breast Cancer (MOve-ABC).
Arm Title
Enhanced Usual Care (EUC)
Arm Type
Experimental
Arm Description
All patients will receive EUC. However, participants assigned to this arm will have ONLY EUC.
Intervention Type
Other
Intervention Name(s)
MOve-ABC
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Enhanced Usual Care
Intervention Description
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 PROMIS-PF surveys beginning at baseline with alerts from scores = or < 45 (indicating moderate or severe impairment) for physical therapy referral
Primary Outcome Measure Information:
Title
Feasibility in terms of percentage of participants completing the study protocol
Time Frame
Through study completion, an average of one year
Title
Number of study participants with a score of less than 45 on the cPRO Physical Function 2-item Questionnaire
Description
Patient reported outcome measure to assess physical function status
Time Frame
Baseline, Month 1, Month 2, Month 3, Month 4, Month 6
Secondary Outcome Measure Information:
Title
Average of all scores across the 6-items of Self-Efficacy for Managing Chronic Disease 6-Item (SEMCD-6) Scale
Description
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.
Time Frame
Baseline, Month 3, Month 6

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mitisha Shah, PT, MPH
Phone
312-503-5638
Email
mitisha.shah@northwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ann Marie Flores, PT, PhD, CLT
Email
ann.flores@northwestern.edu
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann Marie Flores, PT, PhD, CLT
Email
ann.flores@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Mitisha Shah, PT, MPH
Email
mitisha.shah@northwestern.edu

12. IPD Sharing Statement

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

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