Reproductive Health Program for Cancer Patients

(EROS Trial)

Not currently recruiting at 113 trial locations

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Eastern Cooperative Oncology Group

Disqualifiers: Chemotherapy, Radiation, Endocrine therapy, others

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

Compensation: Varies

Number of Visits: 3

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help female cancer patients understand their reproductive health and options. It compares a special program, which includes educational sessions and health assessments, to the usual care patients receive. Pre-menopausal women who have been recently diagnosed with any type of cancer and have not yet started treatments like chemotherapy are ideal candidates. The goal is to enhance knowledge about reproductive risks and assist women in achieving their reproductive goals. As an unphased trial, it provides a unique opportunity for participants to gain valuable insights into their reproductive health while contributing to important research.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this reproductive health program is safe for cancer patients?

Research has shown that reproductive health programs are generally safe for cancer patients. These programs typically include education about reproductive health risks, assessments, and support networks. They aim to help patients understand and achieve their reproductive goals, even during cancer treatment.

Although specific safety data for the reproductive health program in this trial is not available, studies have emphasized the importance of fertility care and education for cancer patients. These programs usually involve non-invasive educational and support activities, which participants generally find easy to handle.

For those considering joining a trial with a reproductive health program, these programs focus on providing information and support rather than medical procedures, posing minimal risk to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Reproductive Health Program for cancer patients because it offers a comprehensive approach to reproductive health, unlike the usual standard practice. This program includes didactics, which are educational sessions, along with a personalized reproductive health assessment and a navigating algorithm to guide patients through their options. Additionally, it emphasizes building a support network, which can be crucial for patients dealing with the complexities of cancer treatment and its impact on reproductive health. These features aim to empower patients with more information and support, potentially leading to better outcomes in managing reproductive health during and after cancer treatment.

What evidence suggests that the reproductive health program is effective for cancer patients?

Research has shown that a reproductive health program, which participants in this trial may receive, can help cancer patients understand their reproductive risks and make informed decisions. One study found that programs focusing on sexual health improved knowledge and reduced distress in women with breast cancer. Another review highlighted effective communication tools that enhance reproductive health, especially for female cancer patients. Comprehensive, patient-centered approaches to sexual health have been shown to boost well-being in cancer survivors. Overall, these findings suggest that such programs can offer meaningful support to patients aiming to achieve their reproductive health goals. ^{6 7 8 9 10}

Who Is on the Research Team?

Ashlesha Patel

Principal Investigator

Eastern Cooperative Oncology Group

Are You a Good Fit for This Trial?

This trial is for pre-menopausal women aged 15-55 with a new cancer diagnosis, including those pregnant or with DCIS. Eligible participants must have cognitive ability to engage in the study and meet specific hormonal criteria. Women who've started chemo, radiation, endocrine therapy, or had certain sterilizing surgeries can't join.

Inclusion Criteria

I am 47 or older, use hormonal birth control, and my FSH level is below 23mIU/mL.

I am a woman diagnosed with any type of cancer for the first time.

I am mentally capable of participating in the study.

Exclusion Criteria

I have had a hysterectomy, my ovaries removed, or been sterilized.

I have started chemotherapy, radiation, or hormone therapy before enrolling in this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development

3 months

Periodic visits as per program requirements

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Follow-up visits at 3, 6, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Reproductive Health Program

Trial Overview The study evaluates a reproductive health program designed to help female cancer patients understand and manage reproductive risks while pursuing their fertility goals. It includes standard practices plus training modules and referral development tailored to each patient's needs.

How Is the Trial Designed?

Group I: Arm B (reproductive health program) Experimental Treatment 1 Intervention

Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development.

Group II: Arm A (no intervention) Active Control 1 Intervention

Patients undergo usual standard practice related to reproductive health.

Who Is Running the Clinical Trial?

Eastern Cooperative Oncology Group

Lead Sponsor

Trials

272

Recruited

153,000+

ECOG-ACRIN Cancer Research Group

Lead Sponsor

Trials

122

Recruited

160,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12218939/

What factors influence sexual and reproductive health care ... AYA cancer patients experiences with sexual and reproductive health care are influenced by their identity factors and contextual enablers.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1462388925000766

Effects of a sexual health enhancement program for ... The program addressed sexual health challenges in women with breast cancer. Sexual distress, body image, and knowledge were improved in breast cancer survivors.

3. ashpublications.org ashpublications.org/ashclinicalnews/news/8252/Study-Identifies-Effective-Tools-to-Address

Study Identifies Effective Tools to Address Reproductive ... A systematic review of communication tools to improve reproductive and sexual health outcomes in female cancer patients identified significant gendered data ...

4. ascopubs.org ascopubs.org/doi/10.1200/EDBK-25-472856

Enhancing Sexual Health for Cancer Survivors A comprehensive, patient-centered approach to sexual health can help improve outcomes and overall well-being for cancer survivors.

5. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-024-12092-8

Implementation of a sexual health clinic in an oncology setting Sexual dysfunction is prevalent among cancer survivors, significantly impacting patient and partner quality of life. Despite this, sexual ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9378486/

Survival Outcomes Following Pregnancy or Assisted ... The 5-year breast-cancer-specific survival rate was 95.6% in the pregnancy group and 90.6% in the non-pregnant group (P=0.002). In Cox proportional hazards ...

7. asrm.org asrm.org/news-and-events/asrm-news/press-releasesbulletins/fertility-and-sterility-publishes-new-research-underscoring-importance-of-ivf-fertility-preservation-access-for-cancer-patients-during-breast-cancer-awareness-month/

Fertility and Sterility Publishes New Research ... The research paper outlines the best practices for fertility preservation for cancer patients as well as the current barriers to fertility care ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0738399125007116

A longitudinal study of decision-making conflict as mediator A prospective longitudinal survey was conducted with 223 cancer patients (aged 18-50) across three regions in China.

9. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.3322/caac.70011

Cancer treatment and survivorship statistics, 2025 - Wagle When stratified by AJCC staging, the 5-year survival rate is >90% for stage I colon and rectal cancers but declines to 12% and 16%, respectively ...

10. kffhealthnews.org kffhealthnews.org/news/article/title-x-family-planning-hhs-opa-trump-cuts-reproductive-health-maine/

The Quiet Collapse of America's Reproductive Health ... Title X clinics provide millions of STI tests each year and are often the only cancer screening sites for uninsured women. Cuts to Medicaid and ...