Reproductive Health Program for Cancer Patients

(EROS Trial)

Recruiting at 108 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

434 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This clinical trial studies reproductive health program in patients with cancer. A reproductive health program may improve patients' understanding of reproductive risks and receipt of appropriate treatment to achieve their reproductive health goals.

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 mentally capable of participating in the study.

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

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+