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

Recruiting at 7 trial locations

Overseen By Shari Goldfarb, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Active secondary cancer, Prior systemic treatment

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

Compensation: Varies

Number of Visits: Unknown

425 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to see how cancer treatment affects sexual and reproductive function. The patient will also be asked to participate in blood draws to see if and how cancer treatment affects the ovaries and the ability to have children (fertility). These blood draws are optional and the patient can still participate in the questionnaire portion of the study even if they choose not to have their blood drawn.

Research Team

Shari Goldfarb, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

Inclusion Criteria

Subject Inclusion Criteria for Cohort of Premenopausal Women with Early Stage Breast Cancer and Lymphoma

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observational Study

Participants complete comprehensive questionnaires related to sexual and reproductive function

5 years

Follow-up

Participants are monitored for changes in sexual and reproductive health, with follow-up questionnaires administered

5 years

Treatment Details

Interventions

• Blood draw
• Surveys
• Transvaginal ultrasounds

Participant Groups

Group I: women with lymphoma Experimental Treatment 3 Interventions

This study is a prospective, observational, longitudinal study assessing the prevalence of sexual dysfunction and distress in premenopausal and postmenopausal women with Diffuse Large B-cell Lymphoma or Hodgkin's Lymphoma. This study will also evaluate the severity, time course, and predictors of sexual dysfunction. Lymphoma patients and survivors will be administered surveys of comprehensive questionnaires related to sexual function. In the case that participants miss the follow up questionnaires, study staff may contact the patient by phone to request and record the patients" responses. The study staff may also mail the missed questionnaires to each patient.

Group II: women with breast cancer Experimental Treatment 3 Interventions

This study is a prospective, observational, longitudinal study assessing the prevalence of sexual dysfunction and distress in premenopausal and postmenopausal women with breast cancer. This study will also evaluate the severity, time course, and predictors of sexual dysfunction. Breast cancer patients and survivors will be administered surveys of comprehensive questionnaires related to sexual function. In the case that participants miss the follow up questionnaires, study staff may contact the patient by phone to request and record the patients" responses. The study staff may also mail the missed questionnaires to each patient.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+