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

145 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Peer Navigator Education for breast cancer survivorship?

Research shows that peer support programs, like the Peer Navigator Education, provide valuable emotional and educational support to breast cancer patients. Studies have found that these programs are well-received by patients and can improve their quality of life by offering guidance and reducing barriers to care. ^{1 2 3 4 5}

Is Peer Navigator Education safe for humans?

The studies on peer navigation programs, including those for cancer survivors, generally focus on feasibility and effectiveness rather than safety. However, no safety concerns have been reported in these studies, suggesting that peer navigation is generally safe for participants. ^{1 5 6 7 8}

How is Peer Navigator Education different from other treatments for breast cancer survivorship?

Peer Navigator Education is unique because it involves trained peers who have experienced breast cancer themselves, providing emotional and psychosocial support to newly diagnosed patients. This approach focuses on personal mentorship and shared experiences, which can enhance the support system for survivors compared to traditional medical treatments. ^{1 2 3 5 9}

What is the purpose of this trial?

This randomized clinical trial studies peer navigator education in improving survivorship care in African American breast cancer survivors. An educational intervention involving peer groups may help to improve the well-being and quality of life (QOL) in breast cancer survivors

Research Team

Kimlin Ashing-Giwa

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Adapting a peer-led self-management program for breast cancer survivors in Switzerland using a co-creative approach. [2020]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Peer navigation in African American breast cancer survivors. [2020]

3. England 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. [2018]

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

Patient Navigation in Breast Cancer Treatment and Survivorship: A Systematic Review. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

Training prostate cancer survivors and caregivers to be peer navigators: a blended online/in-person competency-based training program. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Providing community education: lessons learned from Native Patient Navigators. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Web-Based Peer Navigation for Men with Prostate Cancer and Their Family Caregivers: A Pilot Feasibility Study. [2023]

8. England pubmed.ncbi.nlm.nih.gov

A qualitative evaluation of the Avon Foundation Community Education and Outreach Initiative Patient Navigation Program. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

A core competency framework for prostate cancer peer navigation. [2021]