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

Memorial Sloan Kettering Cancer Center (MSK) logo

Memorial Sloan Kettering Cancer Center (MSK)

Status

Enrolling

Conditions

Breast Cancer
Hodgkin's Lymphoma
Lymphoma

Treatments

Behavioral: surveys
Other: Blood draw
Device: Transvaginal ultrasounds

Study type

Observational

Funder types

Other

Identifiers

NCT01788839
12-249

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

  • 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

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

  • 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

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

  • 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 criteria

Subject Exclusion Criteria for both Pre and Postmenopausal Women with Early Stage Breast Cancer and Lymphoma

  • Active secondary cancer requiring cytotoxic chemotherapy
  • Prior systemic treatment for a malignancy

Trial design

400 participants in 2 patient groups

women with breast cancer
Description:
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.
Treatment:
Device: Transvaginal ultrasounds
Other: Blood draw
Behavioral: surveys
women with lymphoma
Description:
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.
Treatment:
Device: Transvaginal ultrasounds
Other: Blood draw
Behavioral: surveys

Trial contacts and locations

7

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Central trial contact

Jeanne Carter, MD; Shari Goldfarb, MD

Data sourced from clinicaltrials.gov

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