Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and Lymphoma - Full Text View

Purpose

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.

Condition	Intervention
Breast Cancer Lymphoma Hodgkin's Lymphoma	Behavioral: surveys Other: Blood draw Device: Transvaginal ultrasounds


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and Lymphoma

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Lymphoma

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Hodgkin Lymphoma

U.S. FDA Resources

Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:

determine the natural history of sexual and reproductive health [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

predictors of sexual dysfunction during and after treatment [ Time Frame: 5 years ] [ Designated as safety issue: No ]
impact of treatment on self-reported future pregnancy/reproductive health [ Time Frame: 5 years ] [ Designated as safety issue: No ]
factors that influence decisions regarding fertility preservation [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Before treatment and family building after treatment
comparison of sexual function between breast cancer and lymphoma patients [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

blood draw


Estimated Enrollment:	400
Study Start Date:	February 2013
Estimated Study Completion Date:	February 2017
Estimated Primary Completion Date:	February 2017 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.	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.	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).

Groups/Cohorts

Assigned Interventions

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.

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.

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).

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Women for both the premenopausal and postmenopausal cohorts diagnosed with stage 0-III breast cancer or any aggressive lymphpoma will be recruited from breast cancer and lymphoma clinics.

Criteria

Inclusion Criteria:

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

Premenopausal women at time of diagnosis ages 18 to 50 who have either been pregnant or had at least one menstrual period in 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 Cohort of Postmenopausal Women with Early Stage Breast Cancer and Lymphoma

Postmenopausal women at time of diagnosis > age 50 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

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01788839

Contacts


Contact: Shari Goldfarb, MD	646-888-5080
Contact: Maura Dickler, MD	646-888-5456

Locations


United States, New Jersey
Memorial Sloan Kettering at Basking Ridge	Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Shari Goldfarb, MD 646-888-5080
Contact: Maura Dickler, MD 646-888-5456
United States, New York
Memorial Sloan Kettering Cancer Center @ Suffolk	Recruiting
Commack, New York, United States, 11725
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: Maura Dickler, MD 646-888-5456
Memorial Sloan Kettering at Mercy Medical Center	Recruiting
Rockville Centre, New York, United States
Contact: Shari Goldfarb, MD 646-888-5080
Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center	Recruiting
Sleepy Hollow, New York, United States, 10591
Contact: Shari Goldfarb, MD 646-888-5080
Memorial Sloan Kettering Westchester	Recruiting
West Harrison, New York, United States, 10604
Contact: Shari Goldfarb, MD 646-888-5080

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center

Investigators


Principal Investigator:	Shari Goldfarb, MD	Memorial Sloan Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site


Responsible Party:	Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT01788839 History of Changes
Other Study ID Numbers:	12-249
Study First Received:	February 7, 2013
Last Updated:	July 27, 2016
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan Kettering Cancer Center:


Sexual and Reproductive Health premenopausal postmenopausal 12-249 Fertility

Additional relevant MeSH terms:


Lymphoma Breast Neoplasms Hodgkin Disease Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders	Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Neoplasms by Site Breast Diseases Skin Diseases

ClinicalTrials.gov processed this record on September 23, 2016