Cancer Treatment Effects for Breast Cancer and Lymphoma

Recruiting at 8 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

475 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how cancer treatments affect sexual and reproductive health in women with breast cancer and lymphoma. Participants will answer surveys about their sexual health and may choose to have blood draws and transvaginal ultrasounds to assess fertility. Women recently diagnosed with breast cancer or lymphoma, who are starting treatment soon, and who have either had a period or been pregnant in the last year, might be suitable candidates. This study is open to both premenopausal and postmenopausal women. As an unphased trial, it offers participants the opportunity to contribute to important research that could improve future care for women facing similar health challenges.

Do I have to stop taking my current medications for this 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.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to shed light on the sexual and reproductive health of women with breast cancer and lymphoma, areas that are often overlooked in standard care. Unlike typical treatments that focus primarily on cancer eradication, this observational study dives into understanding sexual dysfunction and distress, which are significant quality of life issues for many women. By using detailed surveys and medical assessments like blood draws and transvaginal ultrasounds, the trial seeks to identify the prevalence, severity, and predictors of these issues, potentially guiding future interventions to improve overall patient well-being.

Who Is on the Research Team?

Shari Goldfarb, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Blood draw
• Surveys
• Transvaginal ultrasounds

How Is the Trial Designed?

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+