Peer Ambassador Program for Gynecologic Cancers

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Abramson Cancer Center at Penn Medicine

Must be taking: Chemotherapy

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if peer ambassadors can encourage more people with advanced gynecologic cancer to join clinical trials. Peer ambassadors connect with patients to share information and support their consideration of trial participation. This study targets patients with advanced or high-risk gynecologic cancer who are starting or needing chemotherapy and are not currently in a clinical trial. The goal is to increase conversations and awareness about trial opportunities among these patients. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance patient support and access to clinical trials.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on increasing awareness and enrollment in trials rather than changing current treatments.

What prior data suggests that this peer ambassador intervention is safe?

Research has shown that peer ambassador programs are safe and well-received. These programs connect patients with similar experiences to offer support and guidance. No reports of harm or negative effects have emerged from these programs. The main aim is to improve communication and support, making it a safe option for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Peer Ambassador program is unique because it focuses on social support rather than traditional medical interventions, like chemotherapy or radiation, for gynecologic cancers. While most treatments target the cancer itself, this program aims to enhance patient well-being by pairing them with peers who have shared similar experiences. Researchers are excited about this approach because it could improve emotional and psychological outcomes, offering a complementary benefit to standard medical treatments. By fostering a supportive community, this program might help patients navigate their treatment journey with greater ease and resilience.

What evidence suggests that the Peer Ambassador intervention is effective for improving gynecologic cancer trial enrollment?

Research shows that peer support programs, like the Peer Ambassador initiative, can help patients with gynecologic cancers. This trial will evaluate the Peer Ambassador program as the sole intervention. Studies have found that similar programs, such as the Stronger Together program, reduce depression and stress in cancer patients. These programs also enhance overall quality of life by providing emotional support and shared experiences. Peer mentorship has successfully raised awareness and participation in clinical trials. Although specific data for the Peer Ambassador program remains limited, the positive effects of peer support in similar situations are encouraging. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for patients with advanced or recurrent gynecologic cancers. It's designed to see if peer ambassadors can help more people learn about and join clinical trials.

Inclusion Criteria

Patients who have been discussed at tumor board conferences and recommended to consider clinical trials will screened for recruitment.

Patients will be identified from the UPHS gynecologic oncology and medical oncology clinics serving gynecologic cancer patients (Penn Medicine Washington Square, PCAM/HUP, Radnor, Chester County, Penn Medicine Cherry Hill). Clinic rosters over 6 months intervals will be screened for eligibility.

I have advanced or high-risk gynecologic cancer not currently in a clinical trial.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Peer Ambassador Program

Participants engage in a peer ambassador program where ambassadors facilitate discussions to improve awareness and enrollment in clinical trials

12 months

1-2 encounters per ambassador-mentee pairing

Follow-up

Participants are monitored for outcomes such as feasibility, intention, and acceptability of the ambassador program

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Peer Ambassador

Trial Overview The study is testing a 'peer ambassador' program where trained individuals who have experienced similar health issues support and inform patients about clinical trials for gynecologic cancers.

How Is the Trial Designed?

Group I: Peer Ambassador Experimental Treatment 1 Intervention

There is one arm of the trial which includes the Patient Ambassador intervention.

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Published Research Related to This Trial

A qualitative study involving 24 women with gynaecological cancer revealed that one-to-one telephone peer support can foster emotional bonds and provide empathy, guidance, and hope, helping recipients navigate their illness and recovery.

While many participants reported significant benefits from the peer support, about one-third experienced limited or no benefits, indicating that the effectiveness of such interventions may vary and highlighting the need for further research on factors influencing outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone peer support for women with gynaecological cancer: recipients' perspectives. Pistrang, N., Jay, Z., Gessler, S., et al.[2016]

A peer-to-peer support program was developed to provide emotional support and information to women undergoing treatment for gynecologic cancer and their families, highlighting the importance of psychosocial care in cancer treatment.

Participants in the program reported finding it to be a valuable source of support during their treatment, indicating its potential effectiveness in improving emotional well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Woman to woman: a peer to peer support program for women with gynecologic cancer. Moulton, A., Balbierz, A., Eisenman, S., et al.[2013]

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 Society of Gynecologic Oncologists developed a comprehensive outcomes measure for endometrial cancer treatment, incorporating patient-reported data and assessments over a 120-day postoperative period, based on a study of 297 patients.

The tool aims to establish benchmarks for quality of care, showing that a high percentage of patients maintained independence post-surgery and reported high satisfaction scores, indicating effective treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Society of Gynecologic Oncologists Outcomes Task Force. Study of endometrical cancer: initial experiences. Kennedy, AW., Austin, JM., Look, KY., et al.[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]

The study successfully collected patient-reported outcome measures (PROMs) from 2530 women with gynecologic malignancies, achieving a high completion rate of 78.1%, demonstrating that systematic collection of PROMs in a clinical setting is feasible.

Quality of life scores from this non-trial population were lower than those reported in clinical trials, suggesting that data from trials may not fully represent the experiences of routine patient populations, which is important for informed decision-making in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial findings from a prospective, large scale patient reported outcomes program in patients with gynecologic malignancy. Sisodia, RC., Alimena, S., Ferris, W., et al.[2022]

Citations

1. withpower.com withpower.com/trial/peer-ambassador-program-for-gynecologic-cancers-1c7c3

Peer Ambassador Program for Gynecologic Cancers The overall objective of this study is to design and evaluate a peer ambassador intervention to improve gynecologic cancer trial enrollment.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11567052/

Evaluation of the Stronger Together Peer Mentoring Model ... Stronger Together is a promising model to improve mental health and psychosocial outcomes among patients with breast and gynecologic cancer in VN.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06711380?term=AREA%5BBasicSearch%5D(gynecologic%20cancer)&rank=7

Study Details | NCT06711380 | Patient Ambassador The overall objective of this study is to design and evaluate a peer ambassador intervention to improve gynecologic cancer trial enrollment. ... gynecologic ...

4. bu.edu bu.edu/sph/news/articles/2024/peer-support-may-lower-depression-stress-among-cancer-patients-in-low-resource-settings/

Peer Support May Lower Depression, Stress Among ... New research suggests that a cancer peer support program called Stronger Together helped improve psychological outcomes, as well as overall quality of life.

5. researchgate.net researchgate.net/publication/258822032_Woman_to_Woman_A_Peer_to_Peer_Support_Program_for_Women_With_Gynecologic_Cancer

A Peer to Peer Support Program for Women With ... This article describes the origin and implementation of a peer to peer support program providing emotional support and information to women in ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06711380

Study Details | NCT06711380 | Patient Ambassador The overall objective of this study is to design and evaluate a peer ambassador intervention to improve gynecologic cancer trial enrollment. The primary Aim ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8212279/

“There's somebody like me”: perspectives of a peer-to- ... The W2W program facilitates connections between gynecologic cancer patients to provide peer support and mentorship. Our participants actively sought advice ...

8. worldovariancancercoalition.org worldovariancancercoalition.org/ambassador-information/

Ambassador Information Overall, survival rates fall well below that for other cancers, like breast cancer, where five-year survival rates in many countries are close to 90%. The ...

9. ocrahope.org ocrahope.org/advocacy/industry-council/

Gynecologic Cancer Collaborative | OCRA Explore how the Gynecologic Cancer Collaborative drives research and innovation through collaboration with industry partners to improve ...