Primary Care Program for Breast Cancer Management

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Overseen ByShawna V Hudson, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Rutgers, The State University of New Jersey
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 aims to improve how clinics help people manage symptoms and risks after breast cancer treatment. It tests a new approach, the Practice Led Intervention, where clinic staff receive special training and expert advice to better support breast cancer survivors. Participants in the trial will either experience this new method or continue with the usual care. People who have had breast cancer and are part of a participating practice might be a good fit for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative care strategies that could enhance support for breast cancer survivors.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this organizational intervention is safe for breast cancer management?

Research has shown that supportive care programs like the Practice Led Intervention are safe and effective. For example, a study on a similar nurse-led program found it safe for women with breast cancer undergoing chemotherapy. Another study discovered that exercise programs for cancer patients are generally safe, with only minor side effects. These findings suggest that participants should tolerate the Practice Led Intervention well.12345

Why are researchers excited about this trial?

Researchers are excited about the Practice Led Intervention for breast cancer management because it focuses on enhancing the skills and collaboration of primary care clinic staff. Unlike typical treatments that might involve medication or surgery, this approach emphasizes learning, expert consultation, and feedback to improve patient care. The goal is to integrate comprehensive support within primary care clinics, potentially leading to better outcomes for patients by ensuring they receive consistent and well-coordinated care.

What evidence suggests that this practice led intervention is effective for breast cancer management?

This trial will compare a Practice Led Intervention with Standard of Care for breast cancer management. Research has shown that hands-on approaches, like the Practice Led Intervention in this trial, can improve breast cancer care in local clinics. One study found that training and expert feedback for clinic staff led to better follow-up care for breast cancer patients. Another study demonstrated that using tablets to educate patients about cancer risks in primary care settings had a positive effect. Additionally, nurse-led programs have successfully improved symptoms and quality of life for cancer patients. Overall, these studies suggest that hands-on approaches manage breast cancer symptoms and risks more effectively.678910

Who Is on the Research Team?

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Shawna V Hudson, PhD

Principal Investigator

Rutgers University

Are You a Good Fit for This Trial?

This trial is for staff members or patients who have had breast cancer and are part of a participating practice. They must be able to speak, understand, and read English as well as provide informed consent.

Inclusion Criteria

You work at the clinic or have been a patient there and have had breast cancer.

Exclusion Criteria

I am unable to understand and give consent for treatment.
Unable to speak, understand and/or read English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of intervention strategies including practice facilitation, expert consultation, collaborative learning events, and audit and feedback

6 months
Baseline assessment and intervention activities

Follow-up

Participants are monitored for effectiveness of the intervention and sustainability of follow-up care, symptom, and risk management activities

18 months
Assessments at 6, 12, 18, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Practice Led Intervention
Trial Overview The study is testing an organizational intervention aimed at improving the management of symptoms and risks in breast cancer survivors within primary care settings.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Practice Led InterventionActive Control1 Intervention
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials
471
Recruited
81,700+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

Adapting and implementing breast cancer follow-up in primary ...The primary clinical outcome to test effectiveness is comprehensive breast cancer follow-up care. Implementation will be assessed using ...
Impact of a primary care based intervention on breast ...To estimate the effects of a tablet-based, breast cancer risk education intervention for use in primary care settings (BreastCARE) on patients' breast ...
Co-designing a Primary Care Physiotherapist-led Cancer ...We have described the essential intervention elements and implementation planning of a primary care exercise-based cancer rehabilitation ...
The effectiveness of nurse-led interventions for cancer ...This study aimed to identify, appraise and evaluate the nature and effectiveness of nurse-led interventions on symptoms for people with cancer.
The effectiveness of a nurse-led intervention with the distress ...This study will evaluate the effect of an oncology nurse-led DT intervention compared to usual care on improving the quality of life of patients ...
Effects of a Personal Trainer-Led Exercise Intervention on ...This study examines effects of a personal trainer led exercise intervention on physical activity levels, physical function and quality of life (QoL) in breast ...
Transforming breast cancer management with real-world ...Real-world data (RWD) provide essential insights into the effectiveness and safety of breast cancer treatments, particularly in diverse patient populations, ...
8.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38433074/
The Effects of Nurse-Led Supportive Care Program on ...Our nurse-led supportive care program is an effective, safe and acceptable method to support women with BC receiving adjuvant chemotherapy.
Implementing exercise and self-management for women ...The study assessed the effectiveness of an institution-based exercise and SM program for females with BC undergoing treatment. RE-AIM results ...
Feasibility, safety, and adherence of home-based exercise ...Home-based exercise interventions are feasible and safe for people diagnosed with cancer, with minor adverse events being the most common.
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