75 Participants Needed

Prehabilitation & Education for Breast Cancer

(B-PREPed Trial)

MS
AM
BG
Overseen ByBridget Groble, BS
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Northwestern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether physical therapy and improved patient education before breast cancer treatment can help manage side effects such as joint pain, muscle weakness, and fatigue. Participants will either receive a new program called MOve-ABC, which includes personalized exercise plans and educational support, or enhanced usual care, which may include treatments like Duphalac or Kristalose, with regular check-ins. The goal is to determine if these approaches ease the physical challenges of cancer treatment. Women newly diagnosed with breast cancer, who can stay active and receive text messages, are suitable candidates for this study. As an unphased trial, this study provides an opportunity to contribute to innovative methods for managing cancer treatment side effects.

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.

What prior data suggests that this protocol is safe for breast cancer patients?

A previous study found that patients who did physical therapy before starting breast cancer treatment reported fewer side effects, such as joint pain and muscle weakness. These therapies were manageable, with no new safety issues identified. This finding suggests that starting physical therapy early could help manage or reduce some physical challenges associated with cancer treatment.

For the MOve-ABC program specifically, no direct safety data from past research exists. However, since the trial involves physical therapy and education, which are generally safe, the risk of side effects is likely low. This trial is in a "Not Applicable" phase, meaning it is still exploring practicality and effectiveness, but such activities have a history of being safe. Always consult healthcare providers to ensure it suits individual health needs.12345

Why are researchers excited about this trial?

Researchers are excited about the trial for "Prehabilitation & Education for Breast Cancer" because it explores innovative ways to support recovery and improve outcomes for patients. Unlike the usual care, which typically focuses on post-surgery recovery, the MOve-ABC intervention emphasizes prehabilitation. This means preparing patients physically and mentally before surgery, which could potentially enhance recovery and overall well-being. By incorporating this proactive approach, the trial aims to determine if addressing health and fitness before surgery leads to better outcomes than standard post-treatment care alone.

What evidence suggests that this trial's treatments could be effective for breast cancer?

Research has shown that physical therapy before cancer treatment can help manage side effects like joint pain and muscle weakness. Studies indicate that starting early enables people to better handle these side effects themselves. In this trial, participants in the intervention arm will receive the "Moving On After Breast Cancer" (MOve-ABC) program, which combines physical therapy with education to give patients more control. Early results suggest this method may improve physical abilities and quality of life during and after breast cancer treatment. By offering personalized exercise plans and ongoing support, MOve-ABC aims to boost recovery and overall well-being. Meanwhile, participants in the other arm will receive Enhanced Usual Care (EUC) only.23567

Are You a Good Fit for This Trial?

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 able to care for myself and perform daily activities.
Patients must have the ability to understand and the willingness to sign a written informed consent document prior to registration on study
See 3 more

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.
See 4 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
Group II: Enhanced Usual Care (EUC)Experimental Treatment1 Intervention

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

🇺🇸
Approved in United States as Lactulose for:
🇪🇺
Approved in European Union as Lactulose for:
🇨🇳
Approved in China as Lactulose for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

Northwestern Medicine

Collaborator

Trials
14
Recruited
9,500+

Published Research Related to This Trial

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.
Implementing a system-wide cancer prehabilitation programme: The journey of Greater Manchester's 'Prehab4cancer'.Moore, J., Merchant, Z., Rowlinson, K., et al.[2021]
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.
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]
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.
From Theory to Practice: An International Approach to Establishing Prehabilitation Programmes.Davis, JF., van Rooijen, SJ., Grimmett, C., et al.[2022]

Citations

Improving survival outcomes of people with ABCThe main findings are: a) Clinical trials showed significant survival gains for ABC in 2015-2025, particularly for hormone receptor-positive and ...
Breast Cancer: The good, the bad, and an important call to ...In the past 35 years, breast cancer mortality rates have decreased by 44%. This decrease is attributed to early diagnosis stemming from ...
a global expert review and call-to-action for 2025−2035 ...Advanced breast cancer (ABC) remains an incurable yet treatable disease, requiring lifelong care. While treatment advancements have extended ...
Moving on After Breast Cancer Trial for Depressed ...This large-scale trial in Pakistan aims to evaluate the clinical and cost-effectiveness of a three-stage adaptive intervention to manage depression among breast ...
315P Real-world safety and effectiveness of T-DXd in older ...Median T-DXd line was 5 (range: 2–12) for HER2-low and 4 (range: 2–14) for HER2+ patients. Objective response rates were 45.5% (HER2-low) and 65.6% (HER2+), ...
Real-World Experience of HER2-Positive Advanced Breast ...Advanced breast cancer (ABC) is an incurable disease, with a median overall survival (OS) of 3 years, even in high-income countries.
Treatment Patterns, Safety, and Patient Reported ...This real-world study assessed the breast cancer susceptibility gene 1 or 2 mutation (BRCA1/2mut) status on treatment patterns, safety, and patient-reported ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security