Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and Lymphoma
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01788839 |
Recruitment Status :
Recruiting
First Posted : February 11, 2013
Last Update Posted : March 2, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Breast Cancer Lymphoma Hodgkin's Lymphoma | Behavioral: surveys Other: Blood draw Device: Transvaginal ultrasounds |
Study Type : | Observational |
Estimated Enrollment : | 400 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and Lymphoma |
Study Start Date : | February 2013 |
Estimated Primary Completion Date : | February 2024 |
Estimated Study Completion Date : | February 2024 |

Group/Cohort | Intervention/treatment |
---|---|
women with breast cancer
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.
|
Behavioral: surveys
A survey including the Female Sexual Function Index (FSFI), the Modified Female Sexual Function Index (FSFI-M), the Modified Female Sexual Function Index Follow-Up (FSFI-M Follow-Up) the Sexual Activity Questionnaire (SAQ), the Female Sexual Distress Scale (FSDS-R), the Menopausal Symptom Check List (MSCL), Patient-reported Outcomes Measurement Information System Sexual Function Instrument (PROMIS-SF), Abbreviated Dyadic Adjustment Scale for Relationships (ADAS), Reproductive Health Survey-baseline (RHS-B). Reproductive Health Survey-followup and (RHS-F1)Reproductive Health Survey-followup (RHS-F2) will be conducted at the following intervals: baseline/before chemotherapy +/- 1 month, 3 months after baseline +/- 1 month, 6 months after baseline +/- 1 month, 1 year after baseline +/- 1 month, and at intervals during survivorship that include yearly for 5 years +/- 2 months. Other: Blood draw Those patients receiving chemotherapy who consent to the optional blood draw will provide blood at baseline (before start of chemotherapy), 12 months after baseline (+/-1 month) and 24 months after baseline (+/-2 months). All patients in the subset of the premenopausal cohort receiving tamoxifen only will have required blood draws at baseline (before they begin taking tamoxifen), at 6 months post-baseline/start of tamoxifen (+/- 2 weeks), 12 months post-start of tamoxifen (+/-1 month) and 24 months post-start of tamoxifen (+/-2 months). We will ask these participants for blood draws on day 1, 2, 3 or 4 of their menses at baseline and 6 months post-baseline/start of tamoxifen and during months 1 through 5 post-baseline/start of tamoxifen. Device: Transvaginal ultrasounds Transvaginal ultrasounds are used to determine the number of antral follicles in each ovary. They will be performed to evaluate both the number and size of antral follicles of premenopausal women on Tamoxifen as antral follicle count is a good predictor of ovarian reserve and response. All patients in the subset of the premenopausal cohort receiving tamoxifen only will also have required transvaginal ultrasounds at baseline (before they begin taking tamoxifen) and at 6 months post-start of tamoxifen (+/- 2 weeks). |
women with lymphoma
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.
|
Behavioral: surveys
A survey including the Female Sexual Function Index (FSFI), the Modified Female Sexual Function Index (FSFI-M), the Modified Female Sexual Function Index Follow-Up (FSFI-M Follow-Up) the Sexual Activity Questionnaire (SAQ), the Female Sexual Distress Scale (FSDS-R), the Menopausal Symptom Check List (MSCL), Patient-reported Outcomes Measurement Information System Sexual Function Instrument (PROMIS-SF), Abbreviated Dyadic Adjustment Scale for Relationships (ADAS), Reproductive Health Survey-baseline (RHS-B). Reproductive Health Survey-followup and (RHS-F1)Reproductive Health Survey-followup (RHS-F2) will be conducted at the following intervals: baseline/before chemotherapy +/- 1 month, 3 months after baseline +/- 1 month, 6 months after baseline +/- 1 month, 1 year after baseline +/- 1 month, and at intervals during survivorship that include yearly for 5 years +/- 2 months. Other: Blood draw Those patients receiving chemotherapy who consent to the optional blood draw will provide blood at baseline (before start of chemotherapy), 12 months after baseline (+/-1 month) and 24 months after baseline (+/-2 months). All patients in the subset of the premenopausal cohort receiving tamoxifen only will have required blood draws at baseline (before they begin taking tamoxifen), at 6 months post-baseline/start of tamoxifen (+/- 2 weeks), 12 months post-start of tamoxifen (+/-1 month) and 24 months post-start of tamoxifen (+/-2 months). We will ask these participants for blood draws on day 1, 2, 3 or 4 of their menses at baseline and 6 months post-baseline/start of tamoxifen and during months 1 through 5 post-baseline/start of tamoxifen. Device: Transvaginal ultrasounds Transvaginal ultrasounds are used to determine the number of antral follicles in each ovary. They will be performed to evaluate both the number and size of antral follicles of premenopausal women on Tamoxifen as antral follicle count is a good predictor of ovarian reserve and response. All patients in the subset of the premenopausal cohort receiving tamoxifen only will also have required transvaginal ultrasounds at baseline (before they begin taking tamoxifen) and at 6 months post-start of tamoxifen (+/- 2 weeks). |
- determine the natural history of sexual and reproductive health [ Time Frame: 5 years ]
- predictors of sexual dysfunction during and after treatment [ Time Frame: 5 years ]
- impact of treatment on self-reported future pregnancy/reproductive health [ Time Frame: 5 years ]
- factors that influence decisions regarding fertility preservation [ Time Frame: 5 years ]Before treatment and family building after treatment
- comparison of sexual function between breast cancer and lymphoma patients [ Time Frame: 5 years ]
Biospecimen Retention: Samples Without DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01788839
Contact: Shari Goldfarb, MD | 646-888-5080 | ||
Contact: Jeanne Carter, MD | 646-888-5076 |
United States, New Jersey | |
Memorial Sloan Kettering Basking Ridge | Recruiting |
Basking Ridge, New Jersey, United States, 07920 | |
Contact: Shari Goldfarb, MD 646-888-5080 | |
Memorial Sloan Kettering Monmouth | Recruiting |
Middletown, New Jersey, United States, 07748 | |
Contact: Shari Goldfarb, MD 646-888-5080 | |
Memorial Sloan Kettering Bergen | Recruiting |
Montvale, New Jersey, United States, 07645 | |
Contact: Shari Goldfarb, MD 646-888-5080 | |
United States, New York | |
Memorial Sloan Kettering Commack | Recruiting |
Commack, New York, United States, 11725 | |
Contact: Shari Goldfarb, MD 646-888-5080 | |
Memorial Sloan Kettering Westchester | Recruiting |
Harrison, New York, United States, 10604 | |
Contact: Shari Goldfarb, MD 646-888-5080 | |
Memorial Sloan Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Shari Goldfarb, MD 646-888-5080 | |
Contact: Jeanne Carter, MD 646-888-5076 | |
Memorial Sloan Kettering Nassau | Recruiting |
Uniondale, New York, United States, 11553 | |
Contact: Shari Goldfarb, MD 646-888-5080 |
Principal Investigator: | Shari Goldfarb, MD | Memorial Sloan Kettering Cancer Center |
Responsible Party: | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT01788839 |
Other Study ID Numbers: |
12-249 |
First Posted: | February 11, 2013 Key Record Dates |
Last Update Posted: | March 2, 2022 |
Last Verified: | March 2022 |
Sexual and Reproductive Health premenopausal postmenopausal 12-249 Fertility |
Lymphoma Breast Neoplasms Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Neoplasms by Site Breast Diseases Skin Diseases |