Observational Study on Sexual and Reproductive Health in Women with Breast Cancer and Lymphoma

This observational study aims to understand how breast cancer and lymphoma treatments affect women's sexual and reproductive health over time. Researchers will use surveys, like the Female Sexual Function Index (FSFI), to track changes. For some participants, there's an optional blood draw to see how treatment affects the ovaries and fertility (the ability to have children). Premenopausal women aged 18 and older who have had breast cancer or lymphoma are eligible. The study will look at these effects over five years to understand the natural course of sexual and reproductive health after treatment. The current status of this study is unclear.

Study design
This is an observational study planning to enroll 475 women with breast cancer or lymphoma. It is not a treatment study, but rather aims to understand health changes over time.
What's involved
Participants will complete surveys. Some may also choose to have blood draws at baseline, 12 months, and 24 months, and premenopausal women on Tamoxifen may have transvaginal ultrasounds.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for this study, determining the natural history of sexual and reproductive health, is measured at 5 years.

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NCT01788839

Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and Lymphoma

Recruiting
Not specifiedAges 18+Observational
Memorial Sloan Kettering Cancer Center
~475 participants
Updated 2026-03-04 on ClinicalTrials.gov
What's tested:surveysBlood drawTransvaginal ultrasounds

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
determine the natural history of sexual and reproductive health
Measured over 5 years
Breast Cancer
Lymphoma
Hodgkin's Lymphoma
7 sites across 2 states
New York4
New Jersey3
  • Shari Goldfarb, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Shari Goldfarb, MD
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Eligibility criteria

Inclusion

Women, 18 years of age and older
Premenopausal women at time of diagnosis who have either been pregnant or had at least one menstrual period in the last 12 months
Note: premenopausal women at time of diagnosis who have not been pregnant or have not had at least one menstrual period in the last 12 months are able to participate only if they have had an intrauterine device (IUD) in place within the last 12 months.
Women with newly diagnosed breast cancer (stage 0-III) who are within 1 month of starting systemic treatment or women with any aggressive lymphoma being treated with first line therapy with curative intent.
Breast cancer patients with any receptor type
English speaking
Able to participate in the informed consent process
Women, 18 years of age and older.
Premenopausal women at time of diagnosis who have either been pregnant or had at least one menstrual period in the last 12 months
Note: premenopausal women at time of diagnosis who have not been pregnant or have not had at least one menstrual period in the last 12 months are able to participate only if they have had an intrauterine device (IUD) in place within the last 12 months.
Women with newly diagnosed breast cancer (stage 0-III) who have not yet started treatment and are planning to start Tamoxifen as their only form of systemic treatment within one month
Breast cancer patients with any receptor type
English speaking
Able to participate in the informed consent process
Women, 18 years of age and older.
Postmenopausal women at time of diagnosis who have been without period for ≥ 2 years.
Women with newly diagnosed breast cancer (stage 0-III) who are within 1 month of starting systemic treatment or women with any aggressive lymphoma being treated with first line therapy with curative intent.
Breast cancer patients with any receptor type
English speaking
Able to participate in the informed consent process

Exclusion

Active secondary cancer requiring cytotoxic chemotherapy
Prior systemic treatment for a malignancy
  • determine the natural history of sexual and reproductive health5 years