Prehabilitation & Education for Breast Cancer

(B-PREPed Trial)

Overseen By Bridget Groble, BS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Prior malignancy, ECOG 3+, Upper extremity impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

75 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with your healthcare provider.

How does the treatment 'Enhanced Usual Care, MOve-ABC' differ from other treatments for breast cancer?

The 'Enhanced Usual Care, MOve-ABC' treatment is unique because it incorporates prehabilitation, which involves preparing patients for the physical challenges of cancer treatment through exercise, nutrition, and stress reduction. This approach aims to improve recovery and reduce complications, unlike traditional treatments that focus solely on the cancer itself. ^{1 2 3 4 5}

Eligibility Criteria

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.

Inclusion Criteria

Patients must have regular access to a mobile phone that can receive text messages and phone calls

I am 18 years old or older.

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

Exclusion Criteria

I have had cancer before, but it wasn't skin cancer.

I have a history of conditions affecting my arms, nervous system, or have systemic medical conditions like fibromyalgia.

I am currently undergoing physical therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-habilitation

Participants receive physical therapy and enhanced patient education before breast cancer treatment to help with early identification and self-management of physical and functional side effects.

6 months

3 visits (in-person)

Follow-up

Participants are monitored for physical function and self-efficacy through monthly surveys and assessments.

6 months

Monthly monitoring

Treatment Details

Interventions

• Enhanced Usual Care
• MOve-ABC

Trial Overview 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.

Participant Groups

Group I: Intervention Experimental Treatment 1 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 Treatment 1 Intervention

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

Enhanced Usual Care is already approved in United States, European Union, China for the following indications:

Approved in United States as Lactulose for:

• Hepatic encephalopathy
• Constipation

Approved in European Union as Lactulose for:

• Hepatic encephalopathy
• Constipation

Approved in China as Lactulose for:

• Hepatic encephalopathy
• Constipation

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Northwestern Medicine

Collaborator

Trials

14

Recruited

9,500+

Findings from Research

A systematic review of 25 randomized-controlled trials involving 2682 cancer patients found that prehabilitation programs focusing on exercise training did not show clear benefits over usual care in improving health-related quality of life or reducing postoperative complications.

The overall certainty of the evidence was assessed as very low due to serious methodological concerns, indicating that more research is needed to determine the true effectiveness of prehabilitation programs for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation programs for individuals with cancer: a systematic review of randomized-controlled trials. Meneses-Echavez, JF., Loaiza-Betancur, AF., Díaz-López, V., et al.[2023]

The Prehabilitation process, particularly the Prehab4Cancer program in Greater Manchester, aims to help cancer patients prepare for treatment, reduce recovery time, and improve treatment compliance, especially benefiting older patients.

This program represents a significant advancement in cancer care by integrating physical activity and multi-modal support as a standard practice, showing promise for wider adoption across other regions in the UK.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a system-wide cancer prehabilitation programme: The journey of Greater Manchester's 'Prehab4cancer'. Moore, J., Merchant, Z., Rowlinson, K., et al.[2021]

Prehabilitation for cancer patients is crucial and can be effectively implemented by starting with a small clinical group to refine delivery models and demonstrate proof of concept, as shown through experiences in Canada, the Netherlands, and the UK.

Successful prehabilitation programs require systematic data collection, collaboration among diverse stakeholders, and adaptation to local contexts, emphasizing the importance of a multidisciplinary team and sustainable funding strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From Theory to Practice: An International Approach to Establishing Prehabilitation Programmes. Davis, JF., van Rooijen, SJ., Grimmett, C., et al.[2022]

Prehabilitation for breast cancer survivors is an emerging area that aims to reduce both short- and long-term side effects of cancer treatment, but it is not yet widely studied compared to rehabilitation.

The review suggests five key components for effective prehabilitation: total body exercise, locoregional exercise, nutritional optimization, stress reduction/psychosocial support, and smoking cessation, which could improve outcomes for women undergoing breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Case for Prehabilitation Prior to Breast Cancer Treatment. Santa Mina, D., Brahmbhatt, P., Lopez, C., et al.[2018]

The introduction of an oncological prehabilitation program at our center has been well-received by patients, highlighting its potential to enhance quality of life before cancer treatments.

This program emphasizes the importance of preparatory treatments prior to oncological interventions, suggesting a shift in perspective towards integrating rehabilitation into the continuum of cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Oncological prehabilitation]. Furka, A.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Prehabilitation programs for individuals with cancer: a systematic review of randomized-controlled trials. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Implementing a system-wide cancer prehabilitation programme: The journey of Greater Manchester's 'Prehab4cancer'. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

From Theory to Practice: An International Approach to Establishing Prehabilitation Programmes. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The Case for Prehabilitation Prior to Breast Cancer Treatment. [2018]

5. Hungary pubmed.ncbi.nlm.nih.gov

[Oncological prehabilitation]. [2022]