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Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and Lymphoma
This study is currently recruiting participants.
Verified March 2017 by Memorial Sloan Kettering Cancer Center
Sponsor:
Memorial Sloan Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01788839
First received: February 7, 2013
Last updated: March 13, 2017
Last verified: March 2017
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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:
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 ]
Secondary Outcome Measures:
- 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
blood draw
| Estimated Enrollment: | 400 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | February 2018 |
| Estimated Primary Completion Date: | February 2018 (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).
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes 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
- 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 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
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 | |
| Memorial Sloan Kettering Monmouth | Recruiting |
| Middletown, New Jersey, United States, 07748 | |
| Contact: Shari Goldfarb, MD 646-888-5080 | |
| 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 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:
| 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: | March 13, 2017 |
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 June 28, 2017