Peer Navigator Education for Breast Cancer Survivorship

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Metastatic cancer, Second primary cancer, others

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

Compensation: Varies

Number of Visits: 10

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if peer navigator education, a supportive program led by trained peers, can enhance the quality of life for African American breast cancer survivors. Participants will either join peer-led sessions tailored to their needs or receive educational materials. The trial targets individuals 1-12 months post-treatment for early-stage breast cancer, receiving care through an HMO, and without other major health conditions. As an unphased trial, it offers a unique opportunity to contribute to research that could improve support systems for future breast cancer survivors.

Will I have to stop taking my current medications?

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

What prior data suggests that Peer Navigator Education is safe for breast cancer survivors?

Research has shown that peer navigator education is safe for African American breast cancer survivors. Studies have found this program easy to manage, with no negative effects reported. Participants in these programs experienced benefits such as fewer trauma symptoms and improved emotional well-being. This indicates the program supports survivors without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional breast cancer survivorship care, which often relies on self-driven use of educational materials, the Peer Navigator Education program offers a personalized approach. This treatment is unique because it involves peer navigators who provide tailored support through four sessions, plus a booster session after six months. Researchers are excited about this approach as it aims to enhance patient empowerment and improve outcomes by offering ongoing, personalized guidance, rather than just standard American Cancer Society (ACS) materials alone. This human-centered touch could potentially address the emotional and practical challenges that survivors face, providing a more holistic support system.

What evidence suggests that peer navigator education is effective for improving survivorship care in breast cancer survivors?

Research has shown that education from peer navigators can greatly benefit breast cancer survivors. In this trial, participants in one arm will receive Peer Navigator Education along with ACS materials. One study found that survivors who worked with peer navigators felt more in control, with over 71% feeling confident about managing their care. They also experienced fewer trauma symptoms, particularly feeling less on edge, which improved their emotional well-being. Additionally, survivors felt better informed and more accepting of their illness. This approach has increased confidence and overall quality of life for many who have completed treatment. ^{2 3 4 5 6}

Who Is on the Research Team?

Kimlin Ashing-Giwa

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for African American breast cancer survivors who are 1-12 months post-treatment for stage 0-3 cancer, over 18 years old, and receive care through an HMO. It's not for those with metastatic or a second primary cancer, nor for individuals with major medical conditions like severe anxiety, depression, or substance abuse issues.

Inclusion Criteria

I finished my breast cancer treatment 1-12 months ago.

I have metastatic cancer or a second primary cancer.

Receiving health care primarily through a health maintenance organization (HMO)

Exclusion Criteria

If you have a serious medical or mental health condition, such as anxiety, depression, or problems with alcohol or tobacco, you will not be able to participate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive peer navigator education and ACS materials, with 4 PN sessions and a 6-month booster session

6 months

4 PN sessions, 1 booster session

Follow-up

Participants are monitored for adherence to the SCP schedule of follow-up examinations

6 months

Follow-up at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Peer Navigator Education

Trial Overview

The study tests if peer navigator education can improve the quality of life in these survivors. Participants will be randomly placed into groups where they'll receive educational sessions and counseling from peers to help manage their survivorship care.

How Is the Trial Designed?

Group I: Arm I (PN and ACS material) Experimental Treatment 5 Interventions

Participants receive 4 PN sessions tailored to their needs followed by a 6 month booster session and ACS materials.

Group II: Arm II (ACS material) Active Control 4 Interventions

Participants receive ACS materials only.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The Patient Survivor Advocacy (PSA) program at the University of Wisconsin Breast Center successfully matched 40 newly diagnosed breast cancer patients with trained peer advocates, leading to high satisfaction rates; 92.9% of patients found the program helpful and would recommend it.

All peer advocates reported a sense of achievement in their roles, highlighting the program's effectiveness in providing emotional and psychosocial support, although clinicians faced challenges in referring patients to the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast Cancer Survivor Advocacy at a University Hospital: Development of a Peer Support Program with Evaluation by Patients, Advocates, and Clinicians. Mirrielees, JA., Breckheimer, KR., White, TA., et al.[2018]

The True North Peer Navigation program for men with prostate cancer and their caregivers demonstrated high feasibility and acceptability, with a recruitment rate of 57.9% and a post-questionnaire completion rate of 66.7%.

Participants showed significant improvements in activation, quality of life, and support needs after 3 months, indicating the program's potential effectiveness, which warrants further investigation in a randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Peer Navigation for Men with Prostate Cancer and Their Family Caregivers: A Pilot Feasibility Study. Bender, JL., Flora, PK., Soheilipour, S., et al.[2023]

The Avon Foundation Community Education and Outreach Initiative's Patient Navigation Program was positively received by breast cancer patients, highlighting the strong relationships formed between patients and navigators, who were also breast cancer survivors.

While patients appreciated the navigators' support during appointments, they noted that the enrollment process could be improved, suggesting that enhancing this aspect could benefit similar programs across the US.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative evaluation of the Avon Foundation Community Education and Outreach Initiative Patient Navigation Program. Schlueter, DF., Thompson, WW., Mason, TA., et al.[2019]

Patient navigation programs can significantly increase the rates of post-treatment surveillance mammography in women with breast cancer, suggesting a benefit in monitoring after treatment.

However, there is limited evidence that patient navigation improves treatment outcomes during breast cancer care, indicating a need for further research to fully understand its efficacy in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Navigation in Breast Cancer Treatment and Survivorship: A Systematic Review. Baik, SH., Gallo, LC., Wells, KJ.[2019]

The TrueNTH Peer Navigation Training Program (PNTP) was found to be highly acceptable and effective for training prostate cancer survivors as peer navigators, with a satisfaction score of 9.4 out of 10 and a high usability rating of 84.5 out of 100.

Participants showed significant improvements in understanding learning objectives, self-efficacy, and eHealth literacy, indicating that the program effectively enhanced their knowledge and confidence in supporting others with cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training prostate cancer survivors and caregivers to be peer navigators: a blended online/in-person competency-based training program. Bender, JL., Flora, PK., Milosevic, E., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11507469/

The Role of Peer Support and Patient Navigation for ...

Under CBO-led cancer control, empowerment was high: most survivors felt confident in (71.2%) and knowledgeable about (66.4%) managing their care.

2.

jons-online.com

jons-online.com/issues/2011/february-2011-vol-2-no-1/jons-153

Program Turns Cancer Survivors Into Peer Navigators

For patients, being matched with a peer navigator correlated with a decrease in trauma symptoms— most notably arousal—and improvements in emotional well-being ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01450020

Peer Navigator Education in Improving Survivorship Care ...

Study Overview. Brief Summary. This randomized clinical trial studies peer navigator education in improving survivorship care in African American breast cancer ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11680672/

Empowerment among breast cancer survivors using an ...

The most commonly experienced empowerment outcomes were “being better informed” and “improved acceptance of the illness.” “Exchanging ...

5.

iaap-journals.onlinelibrary.wiley.com

iaap-journals.onlinelibrary.wiley.com/doi/full/10.1111/aphw.12473

What works in peer support for breast cancer survivors: A ...

The aim of the present systematic review and meta-ethnography is to explore the qualitative evidence on the experience of breast cancer survivors in peer ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4230185/

Peer navigation in African American breast cancer survivors

The purpose of this study was to explore the feasibility and acceptability of a peer navigation survivorship program for African American (AA) breast cancer ...