Peer Support for Young Women at High Risk for Breast Cancer

Not currently recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Georgetown University

Disqualifiers: Non-English/Spanish speakers, others

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

Compensation: Varies

Number of Visits: 4

Duration: 3 sessions

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to support young women at high risk for breast cancer due to family history. It will test whether three sessions of telephone counseling, led by peer coaches (community peer coaching), can reduce distress and improve decision-making. Participants will either receive this peer coaching or be directed to usual community peer support services. Women aged 21-30 with close relatives carrying the BRCA1 or BRCA2 gene mutations may be a good fit. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance support services for women at risk.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that these peer support interventions are safe?

Research shows that peer coaching programs, like the one in this trial, are generally safe and well-received. Studies have found that similar phone-based programs can help breast cancer survivors become more active and feel better emotionally. These programs often lead to improved self-care and quality of life without causing harm.

Participants in these studies reported no major negative effects, indicating that peer-led coaching is a low-risk option. Since the focus is on conversation and support, the chance of physical side effects remains very low. Overall, peer coaching in this setting appears to be a safe choice for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the peer support approach for young women at high risk for breast cancer because it offers a unique, community-based method of care. Traditional options for these women often focus on medical or genetic counseling, but community peer coaching includes support from peers who share similar experiences, providing emotional and practical guidance. The PeACE peer coaching arm stands out with its streamlined 30-minute telephone counseling sessions led by well-trained peer coaches from high-risk families, ensuring personalized and relatable support. This method not only empowers participants but also fosters a sense of community, potentially leading to improved mental and emotional well-being, which is often under-addressed in standard care options.

What evidence suggests that this trial's peer support interventions could be effective for young women at high risk for breast cancer?

Research has shown that phone counseling can help women at high risk for breast cancer feel less anxious and make better health decisions. One study found that this type of counseling reduced anxiety about cancer and improved understanding of personal risk. Another study discovered that coaching through mobile devices enhanced the overall quality of life and emotional well-being of breast cancer patients. Additionally, phone counseling has successfully encouraged healthy habits related to breast cancer.

In this trial, participants will join different arms to evaluate the effectiveness of peer coaching and counseling. The Community peer coaching arm will connect participants to peer support through various community groups. Meanwhile, the PeACE peer coaching arm will offer three streamlined 30-minute psychosocial telephone counseling sessions delivered by a well-trained peer coach. These findings suggest that peer coaching and counseling could benefit young women at high risk of breast cancer, particularly in managing stress and making informed health choices. ^{6 7 8 9 10}

Who Is on the Research Team?

Suzanne O'Neill

Principal Investigator

Georgetown University

Are You a Good Fit for This Trial?

This trial is for young adult women aged 21-30 who are biological relatives of someone with a BRCA1/2 mutation, indicating high breast cancer risk. Participants must be able to speak English or Spanish and provide informed consent. Men or women carriers of the mutation can also join if they're over 18.

Inclusion Criteria

I am 18 or older with a BRCA mutation, tested for it.

I am a woman aged 21-30 and a close biological relative of someone with the genetic condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either a 3-session peer coach-led telephone counseling intervention or usual care navigation to peer support interventions

3 sessions

3 telephone sessions

Follow-up

Participants are monitored for distress and decision-making outcomes, including uptake of counseling, with interviews at baseline, 1, 6, and 12 months

12 months

Interviews at baseline, 1, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Community peer coaching
• PeACE

Trial Overview The study compares a telephone counseling intervention led by peer coaches against usual care navigation to community support for hereditary cancer. It aims to see how this affects distress, decision-making, and uptake of genetic counseling in participants over time.

How Is the Trial Designed?

Group I: PeACE peer coaching arm Experimental Treatment 1 Intervention

Behavioral, PeACE, PeACE consists of 3 streamlined 30-minute psychosocial telephone counseling sessions delivered by a well-trained peer coach. Coaches are lay YARs from HBOC families demonstrating good knowledge, communication skills, and protocol mastery.

Group II: Community peer coaching arm Active Control 1 Intervention

Behavioral, usual care, Participants in the usual care arm will receive navigation to peer support with a range of community groups who provide these services.

Who Is Running the Clinical Trial?

Georgetown University

Lead Sponsor

Trials

355

Recruited

142,000+

Published Research Related to This Trial

A 6-month peer-counseling intervention for newly diagnosed women with breast cancer (Sojourners) showed significant improvements in trauma symptoms, emotional well-being, and cancer self-efficacy, indicating that peer support can positively impact their quality of life during treatment.

While peer counselors (Navigators) did not experience negative effects from their role, they reported increased dissatisfaction with medical interactions and emotional suppression, highlighting the need for careful training and supervision to ensure the success of peer navigator programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of peer counseling on quality of life following diagnosis of breast cancer: an observational study. Giese-Davis, J., Bliss-Isberg, C., Carson, K., et al.[2022]

A systematic review of 18 studies, including 16 randomized controlled trials, evaluated the effects of peer-led supportive interventions for cancer patients, focusing on various outcomes like emotional health and quality of life.

The results indicate a need for more rigorous, theory-based evaluations to confirm the effectiveness of these peer-led interventions in cancer care, suggesting that while promising, further research is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Peer-Led Interventions for Patients With Cancer: A Meta-Analysis Lee, MK., Suh, SR.[2019]

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]

A randomized controlled trial involving 104 newly diagnosed breast cancer patients showed that peer-counseling significantly improved breast-cancer-specific well-being and marital adjustment compared to a control group, indicating the efficacy of this intervention.

The study found that patients who perceived their diagnosis as a traumatic stressor benefited even more from peer counseling, experiencing greater improvements in well-being, trauma symptoms, and cancer self-efficacy, highlighting the importance of addressing psychological aspects in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer-counseling for women newly diagnosed with breast cancer: A randomized community/research collaboration trial. Giese-Davis, J., Bliss-Isberg, C., Wittenberg, L., et al.[2017]

A telephone-based peer-delivered intervention significantly reduced breast cancer distress among women with BRCA1 or BRCA2 mutations, showing greater effectiveness compared to usual care at both 4 months and 6 months after the intervention.

Participants in the intervention group also reported lower unmet information needs and reduced stress related to cognitive appraisals about genetic testing, indicating that peer support can effectively address emotional and informational challenges faced by these women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a telephone-based peer-support program for women carrying a BRCA1 or BRCA2 mutation: impact on psychological distress. White, VM., Young, MA., Farrelly, A., et al.[2014]

A 7-week peer support program for women with primary breast cancer showed positive outcomes, including reduced feelings of isolation and enhanced coping skills, as identified through focus group discussions with 8 participants.

The study highlighted the importance of tailoring peer support programs to address specific needs, such as support for hair loss and the inclusion of cancer survivors, to improve the overall effectiveness of these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitated peer support in breast cancer: a pre- and post-program evaluation of women's expectations and experiences of a facilitated peer support program. Power, S., Hegarty, J.[2019]

A national peer support program for women at risk for or surviving breast cancer showed that 37% of participants engaged with the program, with higher utilization among mothers and those at increased genetic risk, indicating targeted outreach could enhance participation.

Participants reported high satisfaction with the peer support program, scoring an average of 42.8 out of 50, suggesting that well-trained lay coaches can effectively meet the diverse needs of breast cancer previvors and survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitators of peer coaching/support engagement and dissemination among women at risk for and surviving with breast cancer. Rehberg, K., Fleischmann, A., Silber, E., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/16916540/

Effects of a Telephone Counseling Intervention on Sisters ... Telephone counseling appears to be a viable tool for reducing risk overestimates and promoting healthy behaviors among sisters of women with breast cancer.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11936599/

Effects of a mobile health coaching intervention on symptom ... The 12-week mobile health coaching program significantly reduced symptoms, improved self-management, and enhanced overall QOL and emotional well-being in breast ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04248257/peer-support-for-young-adult-women-with-high-breast-cancer-risk?page=8&state=VA&city=Arlington

Peer Support For Young Adult Women With High Breast ... The 2-arm PeACE trial includes streamlined telephone counseling delivered by well-trained community peer coaches, with session content ...

4. researchgate.net researchgate.net/publication/7346105_Results_of_a_randomized_study_of_telephone_versus_in-person_breast_cancer_risk_counseling

Results of a randomized study of telephone versus in- ... The counseling decreased women's cancer worry, risk perceptions, and intentions to pursue genetic testing. There were similar effects for both ...

5. stacks.cdc.gov stacks.cdc.gov/view/cdc/106684/cdc_106684_DS1.pdf

adapting effective interventions Even though these women face high lifetime breast cancer risks (approximately 50%), young women with BRCA1/2 mutations face relatively low 10-year breast cancer ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11222759/

Adapting an Efficacious Peer-Delivered Physical Activity ... A 3-month peer-delivered PA program (Moving Forward Together [MFT]) significantly increased the moderate to vigorous PA (MVPA) of survivors of breast cancer.

7. journals.lww.com journals.lww.com/md-journal/fulltext/2025/03210/effects_of_a_mobile_health_coaching_intervention.77.aspx

Effects of a mobile health coaching intervention on ... The 12-week mobile health coaching program significantly reduced symptoms, improved self-management, and enhanced overall QOL and emotional well-being in ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2816689

Telephone-Based Rehabilitation Intervention to Optimize ... In this randomized clinical trial that included 284 women, the intervention resulted in significantly greater improvements in self-selected activity ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7365751/

A Telephone-Based Education And Support Intervention ... To compare two implementation telephone-based strategies of an evidence-based educational and support intervention to Rural Breast Cancer Survivor (RBCS)

10. link.springer.com link.springer.com/article/10.1007/s10865-022-00381-8

A remotely delivered, peer-led intervention to improve ... Results showed it was feasible to recruit and retain younger breast cancer survivors into the 3-month intervention. The technology-based, peer- ...