[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT01788839":3,"trial-entities:NCT01788839":165,"trial-summary:NCT01788839":169},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":14,"conditions":16,"keywords":20,"study_type":25,"primary_purpose":14,"phases":26,"enrollment_info":27,"interventions":30,"primary_outcomes":47,"secondary_outcomes":51,"sex":61,"minimum_age":62,"maximum_age":14,"healthy_volunteers":63,"eligibility_criteria":64,"std_ages":80,"locations":83,"central_contacts":154,"overall_officials":157,"references":160,"see_also_links":161},"NCT01788839","12-249","Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and Lymphoma","RECRUITING","2027-02","2026-03","2026-03-04","2013-02","Memorial Sloan Kettering Cancer Center","OTHER",null,"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.",[17,18,19],"Breast Cancer","Lymphoma","Hodgkin's Lymphoma",[21,22,23,5,24],"Sexual and Reproductive Health","premenopausal","postmenopausal","Fertility","OBSERVATIONAL",[],{"count":28,"type":29},475,"ESTIMATED",[31,38,42],{"type":32,"name":33,"description":34,"armGroupLabels":35},"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\u002Fbefore chemotherapy +\u002F- 1 month, 3 months after baseline +\u002F- 1 month, 6 months after baseline +\u002F- 1 month, 1 year after baseline +\u002F- 1 month, and at intervals during survivorship that include yearly for 5 years +\u002F- 2 months.",[36,37],"women with breast cancer","women with lymphoma",{"type":13,"name":39,"description":40,"armGroupLabels":41},"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 (+\u002F-1 month) and 24 months after baseline (+\u002F-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\u002Fstart of tamoxifen (+\u002F- 2 weeks), 12 months post-start of tamoxifen (+\u002F-1 month) and 24 months post-start of tamoxifen (+\u002F-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\u002Fstart of tamoxifen and during months 1 through 5 post-baseline\u002Fstart of tamoxifen.",[36,37],{"type":43,"name":44,"description":45,"armGroupLabels":46},"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 (+\u002F- 2 weeks).",[36,37],[48],{"measure":49,"timeFrame":50},"determine the natural history of sexual and reproductive health","5 years",[52,54,56,59],{"measure":53,"timeFrame":50},"predictors of sexual dysfunction during and after treatment",{"measure":55,"timeFrame":50},"impact of treatment on self-reported future pregnancy\u002Freproductive health",{"measure":57,"description":58,"timeFrame":50},"factors that influence decisions regarding fertility preservation","Before treatment and family building after treatment",{"measure":60,"timeFrame":50},"comparison of sexual function between breast cancer and lymphoma patients","FEMALE","18 Years",false,{"inclusion":65,"exclusion":76,"raw_text":79},[66,67,68,69,70,71,72,73,67,68,74,70,71,72,73,75,69,70,71,72],"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","Women, 18 years of age and older.","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","Postmenopausal women at time of diagnosis who have been without period for ≥ 2 years.",[77,78],"Active secondary cancer requiring cytotoxic chemotherapy","Prior systemic treatment for a malignancy","Inclusion Criteria:\n\nSubject Inclusion Criteria for Cohort of Premenopausal Women with Early Stage Breast Cancer and Lymphoma\n\n* Women, 18 years of age and older\n* Premenopausal women at time of diagnosis who have either been pregnant or had at least one menstrual period in the last 12 months\n\n  * 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.\n* 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.\n* Breast cancer patients with any receptor type\n* English speaking\n* Able to participate in the informed consent process\n\nSubject Inclusion Criteria for Tamoxifen Only Subset of Cohort of Premenopausal Women with Early Stage Breast Cancer and Lymphoma\n\n* Women, 18 years of age and older.\n* Premenopausal women at time of diagnosis who have either been pregnant or had at least one menstrual period in the last 12 months\n\n  * 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.\n* 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\n* Breast cancer patients with any receptor type\n* English speaking\n* Able to participate in the informed consent process\n\nSubject Inclusion Criteria for Cohort of Postmenopausal Women with Early Stage Breast Cancer and Lymphoma\n\n* Women, 18 years of age and older.\n* Postmenopausal women at time of diagnosis who have been without period for ≥ 2 years.\n* 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.\n* Breast cancer patients with any receptor type\n* English speaking\n* Able to participate in the informed consent process\n\nExclusion Criteria:\n\nSubject Exclusion Criteria for both Pre and Postmenopausal Women with Early Stage Breast Cancer and Lymphoma\n\n* Active secondary cancer requiring cytotoxic chemotherapy\n* Prior systemic treatment for a malignancy",[81,82],"ADULT","OLDER_ADULT",[84,98,107,116,126,135,145],{"facility":85,"status":7,"city":86,"state":87,"zip":88,"country":89,"contacts":90,"geoPoint":95},"Memorial Sloan Kettering Basking Ridge","Basking Ridge","New Jersey","07920","United States",[91],{"name":92,"role":93,"phone":94},"Shari Goldfarb, MD","CONTACT","646-888-5080",{"lat":96,"lon":97},40.70621,-74.54932,{"facility":99,"status":7,"city":100,"state":87,"zip":101,"country":89,"contacts":102,"geoPoint":104},"Memorial Sloan Kettering Monmouth","Middletown","07748",[103],{"name":92,"role":93,"phone":94},{"lat":105,"lon":106},40.39428,-74.11709,{"facility":108,"status":7,"city":109,"state":87,"zip":110,"country":89,"contacts":111,"geoPoint":113},"Memorial Sloan Kettering Bergen","Montvale","07645",[112],{"name":92,"role":93,"phone":94},{"lat":114,"lon":115},41.04676,-74.02292,{"facility":117,"status":7,"city":118,"state":119,"zip":120,"country":89,"contacts":121,"geoPoint":123},"Memorial Sloan Kettering Commack","Commack","New York","11725",[122],{"name":92,"role":93,"phone":94},{"lat":124,"lon":125},40.84288,-73.29289,{"facility":127,"status":7,"city":128,"state":119,"zip":129,"country":89,"contacts":130,"geoPoint":132},"Memorial Sloan Kettering Westchester","Harrison","10604",[131],{"name":92,"role":93,"phone":94},{"lat":133,"lon":134},40.96899,-73.71263,{"facility":12,"status":7,"city":119,"state":119,"zip":136,"country":89,"contacts":137,"geoPoint":142},"10065",[138,139],{"name":92,"role":93,"phone":94},{"name":140,"role":93,"phone":141},"Jeanne Carter, MD","646-888-5076",{"lat":143,"lon":144},40.71427,-74.00597,{"facility":146,"status":7,"city":147,"state":119,"zip":148,"country":89,"contacts":149,"geoPoint":151},"Memorial Sloan Kettering Nassau","Uniondale","11553",[150],{"name":92,"role":93,"phone":94},{"lat":152,"lon":153},40.70038,-73.59291,[155,156],{"name":92,"role":93,"phone":94},{"name":140,"role":93,"phone":141},[158],{"name":92,"affiliation":12,"role":159},"PRINCIPAL_INVESTIGATOR",[],[162],{"label":163,"url":164},"Memorial Sloan-Kettering Cancer Center","http:\u002F\u002Fwww.mskcc.org\u002F",{"nct_id":4,"conditions":166,"biomarkers":168},[167,18],"Breast Carcinoma",[],{"nct_id":4,"found":170,"summary":171,"prompt_version":181},true,{"design":172,"status":173,"heading":174,"summary":175,"follow_up":176,"word_count":177,"commitments":178,"compensation":179,"drugs_mentioned":180},"This is an observational study planning to enroll 475 women with breast cancer or lymphoma. It is not a treatment study, but rather aims to understand health changes over time.","completed","Observational Study on Sexual and Reproductive Health in Women with Breast Cancer and Lymphoma","This observational study aims to understand how breast cancer and lymphoma treatments affect women's sexual and reproductive health over time. Researchers will use surveys, like the Female Sexual Function Index (FSFI), to track changes. For some participants, there's an optional blood draw to see how treatment affects the ovaries and fertility (the ability to have children). Premenopausal women aged 18 and older who have had breast cancer or lymphoma are eligible. The study will look at these effects over five years to understand the natural course of sexual and reproductive health after treatment. The current status of this study is unclear.","The primary endpoint for this study, determining the natural history of sexual and reproductive health, is measured at 5 years.",101,"Participants will complete surveys. Some may also choose to have blood draws at baseline, 12 months, and 24 months, and premenopausal women on Tamoxifen may have transvaginal ultrasounds.","Not stated in the trial record.",[33,39],"v2"]