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Behavioural Intervention

Prehabilitation & Education for Breast Cancer (B-PREPed Trial)

Phase 1

Recruiting

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have an ECOG Performance Scale score of 0, 1, or 2

Patients must be age ≥ 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of one year

Awards & highlights

B-PREPed Trial Summary

This trial aims to assess the effects of physical therapy and enhanced patient education before breast cancer treatment. It will compare two groups and measure physical and functional side effects, self-management, and provider knowledge and behaviors.

Who is the study for?

This trial is for English-speaking women over 18 with newly diagnosed Breast Cancer (stages 0-4) who are set to receive treatment aimed at curing the disease. They must be able to sign consent, have a mobile phone, and an ECOG score of 0-2. Excluded are those with prior cancers (except skin), certain medical conditions like lymphedema or diabetes, current physical therapy, severe brain metastasis effects, or pregnancy.Check my eligibility

What is being tested?

The study tests 'Moving On-After Breast Cancer' (MOve-ABC), which includes patient education on physical function, a physical therapy evaluation, home exercises plus monthly monitoring versus enhanced usual care that only involves monthly monitoring. The goal is to manage side effects from cancer treatment better.See study design

What are the potential side effects?

Potential side effects from the interventions may include joint pain, muscle weakness, and fatigue leading to functional impairment. These are common issues associated with breast cancer treatments that the MOve-ABC program aims to address early.

B-PREPed Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to care for myself and perform daily activities.

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I am 18 years old or older.

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I am female.

B-PREPed Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

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 "Patient Reported Outcome Measurement Information System Physical Function Custom Form v2.0 Computerized Patient Reported Outcomes"

Secondary outcome measures

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

B-PREPed Trial Design

2Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment1 Intervention

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

Group II: Enhanced Usual Care (EUC)Experimental Treatment1 Intervention

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,589 Previous Clinical Trials

917,012 Total Patients Enrolled

38 Trials studying Breast Cancer

12,400 Patients Enrolled for Breast Cancer

Northwestern MedicineOTHER

10 Previous Clinical Trials

8,467 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Intervention met the regulatory standards set forth by the FDA?

"Due to the paucity of clinical data available, Intervention was assigned a safety score of 1. This is in keeping with it being a Phase 1 trial that has limited proof for its efficacy and security."

Answered by AI

Are recruitment efforts currently underway for this experiment?

"According to clinicaltrials.gov, this medical study is no longer enrolling participants; it was initially posted on October 1st 2023 and the most recent update was made on October 9th 2023. Nevertheless, there are still 2718 other trials that are actively recruiting patients at present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Ann Marie Flores 2023. "Breast Cancer Pre-habilitation and Prospective Surveillance to Prevent, Detect, and Optimize Physical and Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06081127.