Pre-habilitation and surveillance for breast cancer patients
A Randomized Pilot Test of the Breast Cancer Pre-habilitation and Prospective Surveillance to Prevent, Detect, and Optimize Physical and Functional Recovery
This study is testing a physical therapy program called 'Moving On-After Breast Cancer' to see if it helps newly diagnosed breast cancer patients manage side effects like joint pain and fatigue before their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Northwestern University Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06081127 on ClinicalTrials.gov |
What this trial studies
This research focuses on assessing the feasibility and potential effects of a physical therapy intervention called 'Moving On-After Breast Cancer' (MOve-ABC) for patients newly diagnosed with breast cancer. The intervention aims to help patients manage physical and functional side effects, such as joint pain and fatigue, before they undergo cancer treatment. The study will compare the effects of MOve-ABC against enhanced usual care within a large academic medical system to refine the intervention for future trials. Additionally, it will evaluate the impact of MOve-ABC on patient self-management and healthcare provider behaviors.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 and older with newly diagnosed breast cancer (stages 0-4) who are eligible for intent-to-cure treatment.
Not a fit: Patients who are male or those with advanced performance status (ECOG score greater than 2) may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the physical well-being and self-management skills of breast cancer patients during treatment.
How similar studies have performed: Other studies have shown promise with similar pre-habilitation approaches, indicating potential for success in this intervention.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois
- Northwestern University — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Bridget Groble, BS
- Email: bridget.groble@northwestern.edu
- Phone: 312-503-5067
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.