Prehabilitation & Education for Breast Cancer

(B-PREPed Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Northwestern University

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

No Placebo Group

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.

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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.

Trial 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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Northwestern University Chicago, IL

Who Is Running the Clinical Trial?

Northwestern University Lead Sponsor

Northwestern Medicine Collaborator

References

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

Prehabilitation programs for individuals with cancer: a systematic review of randomized-controlled trials. [2023] Prehabilitation programs focusing on exercise training as the main component are known as a promising alternative for improving patients' outcomes before cancer surgery. This systematic review determined the benefits and harms of prehabilitation programs compared with usual care for individuals with cancer.

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

Implementing a system-wide cancer prehabilitation programme: The journey of Greater Manchester's 'Prehab4cancer'. [2021] Patients undergoing major cancer interventions such as major surgical resection, chemotherapy, radiotherapy, and immunotherapy are prone to the adverse effects of their cancer, as well as to the side effects of the treatments designed to cure them. The Prehabilitation process supports cancer patients in preparing for the physiological challenges of their cancer treatments, whilst aiming to shorten recovery time, reduce peri-operative complications and improve compliance with non-surgical treatments. Prehabilitation will be most useful in older patients. Greater Manchester Integrated Care system is the first regional system in the UK to introduce delivery of system-wide, large scale physical activity supported multi-modal prehabilitation and recovery programme, Prehab4Cancer as a standard of care for cancer patients. It builds upon the successful implementation of Enhanced Recovery After Surgery + programme to improve surgical care in Greater Manchester. During this review we describe the journey to develop a system wide prehabilitation model for patients with cancer. Prehab4Cancer to date has focused on robust co-design, development, and implementation of an effective service model with attention paid to stakeholder engagement. This has led to receipt of high numbers of referrals from across Greater Manchester for the all the cancer groups involved. The successful implementation of the P4C pathway in GM presents a best practice model that might be adopted by other local and combined authority areas nationally.

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

From Theory to Practice: An International Approach to Establishing Prehabilitation Programmes. [2022] This article focuses on the following:The importance of prehabilitation in people with cancer and the known and hypothesised benefits.Exploration of the principles that can be used when developing services in the absence of a single accepted model of how these services could be established or configured.Description of approaches and learning in the development and implementation of prehabilitation across three different countries: Canada, the Netherlands and the United Kingdom, based on the authors' experiences and perspectives.

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

The Case for Prehabilitation Prior to Breast Cancer Treatment. [2018] Cancer rehabilitation in breast cancer survivors is well established, and there are many studies that focus on interventions to treat impairments as well as therapeutic exercise. However, very little is known about the role of prehabilitation for people with breast cancer. In this narrative review, we describe contemporary clinical management of breast cancer and associated treatment-related morbidity and mortality considerations. Knowing the common short- and long-term sequelae, as well as less frequent but serious sequelae, informs our rationale for multimodal breast cancer prehabilitation. We suggest 5 core components that may help to mitigate short- and long-term sequelae that align with consensus opinion of prehabilitation experts: total body exercise; locoregional exercise pertinent to treatment-related deficits; nutritional optimization; stress reduction/psychosocial support; and smoking cessation. In each of these categories, we review the literature and discuss how they may affect outcomes for women with breast cancer.

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

[Oncological prehabilitation]. [2022] Cancer is currently the second leading cause of death in developed countries. Precision oncology treatments have significantly improved morbidity and mortality rates, 60% of patients can be cured or the disease can be managed as a chronic condition, so preserving and optimizing quality of life is just as important as successful treatment. The integration of rehabilitation has become generally accepted, however, preparatory treatments prior to oncological interventions should also receive more and more emphasis. In our center, we introduced the so-called oncological prehabilitation program that is a preparation treatment before oncological interventions. The program is popular among patients, and the positive feedback affects team members as well. Our goal is to present the structure and expected benefits of oncology prehabilitation as well as the possibilities of integrating it into the continuum of care, thereby introducing a change of perspective and paradigm shift. With oncological prehabilitation, we can witness a change of attitude and paradigm shift. Additional services supporting successful oncology treatments improve the quality of life, which - if there is an intention and need - could be implemented in oncology centers even with the current human resources. Orv Hetil. 2022; 163(50): 1975-1981.