Peer Support for Young Women at High Risk for Breast Cancer
Recruiting in Palo Alto (17 mi)
+5 other locations
Overseen bySuzanne O'Neill
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Georgetown University
Disqualifiers: Non-English/Spanish speakers, others
No Placebo Group
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.
12345How 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.
12467Eligibility 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.
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: PeACE peer coaching armExperimental Treatment1 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 armActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Georgetown UniversityWashington, United States
Hackensack University Medical CenterHackensack, NJ
Dana Farber Cancer CenterBoston, MA
Memorial Sloan Kettering Cancer CenterNew York, NY
More Trial Locations
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Who Is Running the Clinical Trial?
Georgetown UniversityLead Sponsor
References
Facilitators of peer coaching/support engagement and dissemination among women at risk for and surviving with breast cancer. [2021]One-on-one peer coaching/support programs hold promise in promoting healthy outcomes among women at risk for and surviving with breast cancer, with the potential to bridge gaps in "whole person care." Although popularly cited for their benefits, emerging evidence is mixed and suggests that peer support program impacts may be attenuated by individual- and community-specific factors. We evaluated a national not-for-profit breast cancer organization's peer support program outcomes (2015-2018) serving women from predominantly Jewish backgrounds to examine program engagement, facilitation, and satisfaction. Of the N = 392 women sampled, 37% utilized the peer support program: the majority were referred by a family member/friend (40%) or had connected with the program online (34%). Logistic regression modeling revealed that mothers (odds ratio [OR] = 1.82; 95% confidence interval [CI] = 1.04 to 3.19), women at increased genetic risk for breast cancer (OR = 2.07; 95% CI = 1.08 to 3.94), and those who connected with the organization through a family member/friend (OR = 1.97; 95% CI = 1.23 to 3.15) were significantly more likely to utilize peer support (all p's
The effect of peer counseling on quality of life following diagnosis of breast cancer: an observational study. [2022]Women with breast cancer express the greatest need for counseling at the time of diagnosis and report that the intervention they want is to be able to speak with someone who has the same cancer, but has lived through the crisis of treatment and is leading a 'normal' life. We conducted an observational study of a 6-month peer-counseling intervention testing outcomes for both newly diagnosed women (Sojourners) and peer counselors (Navigators) as a first step toward the goal of validating a peer navigator program. Significant improvement in the Sojourners was observed in trauma symptoms, emotional well-being, cancer self-efficacy, and desire for information on breast cancer resources. Navigators maintained baseline levels of the outcome variables, but increased in dissatisfaction with their interactions with their medical team and increased emotional suppression. Our findings indicate that peer navigation may halt a decline in quality of life that is commonly found in the first year following breast cancer diagnosis. In addition, Navigators were not adversely affected by their experience; however, careful training and supervision of Navigators is crucial to overall success. Randomized clinical trials are needed to demonstrate the efficacy of peer navigator programs.
Peer-counseling for women newly diagnosed with breast cancer: A randomized community/research collaboration trial. [2017]We conducted a randomized controlled trial of peer-counseling for newly diagnosed breast cancer (BC) patients as a community/research collaboration testing an intervention developed jointly by a community-based-organization serving women with cancer and university researchers.
Breast Cancer Survivor Advocacy at a University Hospital: Development of a Peer Support Program with Evaluation by Patients, Advocates, and Clinicians. [2018]Peer-to-peer support programs provide unique psychosocial and educational support for breast cancer patients. A Patient Survivor Advocacy (PSA) program was developed by the University of Wisconsin Breast Center (UWBC) to provide support for newly diagnosed patients from peers who had completed primary treatment. In this study, we evaluated patient, advocate, and clinician experience with the PSA program. A program matching volunteer peer advocates at least 1 year removed from primary treatment with newly diagnosed patients was developed. Peer advocates were recruited from the practices of UWBC clinicians and received in-person training on six dimensions of peer advocacy. Trained advocates were then paired based on demographic and medical history with new patients referred to the program. Survey assessment tools were distributed to assess peer advocate and patient satisfaction, as well as clinician experience. Forty patients have been matched with seven advocates, with contact largely by email (53 %) or phone (36 %). Patients and peer advocates reported satisfaction with the program. The majority of patients (92.9 %) reported that the program was "helpful" and that they would recommend the PSA program to another woman with breast cancer. All peer advocates (100 %) responded with a sense of achievement in their advocate roles. Clinicians noted challenges in referral to the program. Peer advocates can provide key emotional and psychosocial support to newly diagnosed breast cancer patients. The peer advocate, patient, and clinician feedback collected in this study will inform the future development of this program at our and peer institutions.
Randomized controlled trial of a telephone-based peer-support program for women carrying a BRCA1 or BRCA2 mutation: impact on psychological distress. [2014]To assess the effectiveness of a telephone-based peer-delivered intervention in reducing distress among women with a BRCA1 or BRCA2 gene mutation. The intervention involved trained peer volunteers contacting women multiple times over a 4-month period to provide informational, emotional, and practical support.
Effects of Peer-Led Interventions for Patients With Cancer: A Meta-Analysis [2019]To evaluate the effects of peer-led supportive interventions for patients with cancer. .
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]Peer support programs are associated with the provision of emotional, informational, and appraisal support. The benefits of peer support for women with breast cancer include reduced social isolation, enhanced coping, and access to information.