Peer Support for Young Women at High Risk for Breast Cancer

Recruiting at 5 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

560 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will recruit young adult female relatives (YARs) of male or female carriers of BRCA1/2. YARs who consent to participate will be randomized to either a 3-session peer coach-led telephone counseling intervention or usual care navigation to peer support interventions provided by community organizations that support the hereditary cancer community. Study aims are to 1) Assess intervention effects on distress and decision making outcomes, including uptake of counseling for untested YARs, 2) Identify YARs most likely to engage with and benefit from the intervention, 3) Understand intervention mechanisms. Participants will complete interviews at baseline, 1, 6, and 12 months.

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 data supports the effectiveness of the treatment Community peer coaching, Peer Support, Telephone Counseling Intervention, PeACE for young women at high risk for breast cancer?

Research shows that peer support programs can improve emotional well-being and provide valuable psychosocial support for women at risk for or diagnosed with breast cancer. Studies indicate that these programs can help maintain quality of life and reduce psychological distress, especially when delivered through trained peer volunteers. ^{1 2 3 4 5}

How is the treatment 'Community peer coaching' unique for young women at high risk for breast cancer?

Community peer coaching is unique because it involves one-on-one support from someone who has experienced a similar health journey, providing emotional and informational support through phone calls. This approach focuses on the whole person, aiming to reduce social isolation and improve coping skills, which is different from traditional medical treatments that primarily focus on physical health. ^{1 2 4 6 7}

Research Team

Suzanne O'Neill

Principal Investigator

Georgetown University

Eligibility Criteria

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.

Exclusion Criteria

I can speak English or Spanish and can give informed consent.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Facilitators of peer coaching/support engagement and dissemination among women at risk for and surviving with breast cancer. [2021]

2. England pubmed.ncbi.nlm.nih.gov

The effect of peer counseling on quality of life following diagnosis of breast cancer: an observational study. [2022]

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

Peer-counseling for women newly diagnosed with breast cancer: A randomized community/research collaboration trial. [2017]

4. 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]

5. United States 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. [2014]

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

Effects of Peer-Led Interventions for Patients With Cancer: A Meta-Analysis [2019]

7. United States 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. [2019]