330 Participants NeededMy employer runs this trial

Navigation Program for Breast Cancer Survivors

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Overseen ByThe Ohio State University Comprehensive Cancer Center
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Ohio State University Comprehensive Cancer Center
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 determine if a navigation program can help breast cancer survivors better access support services like psychological and nutrition counseling. Many survivors have unmet needs, and participation in these programs is often low, particularly among minority women. The navigation program guides survivors through the healthcare system, assisting with scheduling and attending appointments. This trial suits anyone treated for non-metastatic breast cancer, especially those who are Black, Hispanic, or living in rural areas. As an unphased trial, it provides a unique opportunity to improve access to essential support services and enhance the quality of life for breast cancer survivors.

What prior data suggests that this navigation program is safe for breast cancer survivors?

Research has shown that patient navigation programs are safe and generally well-received, enhancing the quality of life for cancer patients. For example, one study found that patient navigation reduced distress and improved quality of life over 18 months. Another study noted increased satisfaction during the recovery phase due to patient navigation.

No reports of negative effects from patient navigation programs exist. Instead, these programs have positively impacted, especially for disadvantaged groups. In some cases, patient navigation has even been linked to better survival rates. For instance, at Harlem Hospital, the survival rate for breast cancer patients improved significantly after implementing a patient navigation program.

Overall, evidence suggests that patient navigation is a safe option for those considering joining a clinical trial focused on this type of support.12345

Why are researchers excited about this trial?

Researchers are excited about the Navigation Program for Breast Cancer Survivors because it emphasizes personalized support through patient navigation. Unlike traditional follow-up care, which often involves standard medical appointments and monitoring, this program provides tailored coaching sessions and additional support for underserved or vulnerable patients. By helping patients navigate their survivorship care with personalized assistance, the program aims to enhance access to necessary resources and improve overall quality of life for breast cancer survivors.

What evidence suggests that this navigation program is effective for improving survivorship support service participation among non-metastatic breast cancer survivors?

Research shows that patient navigation can greatly benefit cancer patients. Studies have found it helps patients begin treatment sooner and enhances their quality of life. In this trial, participants will receive supportive care through a breast cancer survivor navigation program. Specifically, these programs have led to a 12% increase in mammogram screenings for breast cancer survivors. They also boost patients' confidence and knowledge in managing their care. This evidence suggests that patient navigation can effectively encourage non-metastatic breast cancer survivors to engage in support services.12356

Who Is on the Research Team?

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Bridget A Oppong, MD, MPH

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for people who have survived breast cancer that has not spread beyond the breast (non-metastatic). It aims to include survivors needing more support after treatment, especially those from underserved or minority backgrounds.

Inclusion Criteria

GENERAL INCLUSION (PRIMARY OBJECTIVE): Received care at Stefanie Spielman Breast Center
COACHING INCLUSION (SECONDARY OBJECTIVE): Referred patients who are Black and/or Hispanic
I am 70 years old or older and have been referred as a patient.
See 3 more

Exclusion Criteria

I have metastatic breast cancer now.
Prisoners or individuals unable to consent
Non-English and non-Spanish speakers

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Consultation

Participants receive a referral to survivorship at James Cancer Supportive Care Clinic and attend a survivorship consultation visit consisting of standard survivorship care and referrals.

1 visit
1 visit (in-person)

Navigation Program

Participants receive patient navigator support to help with scheduling survivorship consultation visits. Underserved/vulnerable patients may attend five patient navigator coaching sessions over 90 days.

90 days

Follow-up

Participants are monitored for changes in self-efficacy and quality of life using PROMIS-10 and BSES scores at 90-day follow-up.

90 days

What Are the Treatments Tested in This Trial?

Interventions

  • Patient Navigation

Trial Overview

The study tests whether a patient navigation program—where staff help guide survivors to supportive care services like counseling and nutrition advice—increases participation in these programs compared to usual care. Participants may also complete surveys.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Supportive care (breast cancer survivor navigation program)Experimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials
350
Recruited
295,000+

Citations

Patient Navigation in Cancer Treatment: A Systematic Review

Of these, 70% (n = 16) reported a significant reduction in time to treatment with patients that received navigation. These positive outcomes were observed ...

Patient Navigation Effect on Cancer Patients' Quality of Life ...

Cancer patients all significantly improved from 6 to 18 months after enrollment. Both high and low users of the program had improved DT scores, total FACT-G ...

Patient navigation across the cancer care continuum: An ...

Emerging evidence suggests that patient navigation improves quality of life and patient satisfaction with care in the survivorship phase and ...

Patient navigation for early detection, diagnosis and ...

It has been proven to improve cancer screening rates, reduce time to diagnosis and hospital readmissions, increase adherence to surveillance ...

Patient Navigation in Breast Cancer Treatment and ...

Overall, results demonstrated that patient navigation increases surveillance mammography rates, but only minimal evidence was found with regard ...

Patient Navigators Improve Outcomes for Breast Cancer ...

At Harlem Hospital alone, the five-year survival rate jumped from 39 percent prior at the program's start to 70 percent.