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

Обзор

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.

Вмешательства

• Поведенческое 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-basel
• Другое 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 mon
• Устройство 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 tamox

Первичные конечные точки

• determine the natural history of sexual and reproductive health [Срок оценки: 5 years]

Вторичные конечные точки (4)

• predictors of sexual dysfunction during and after treatment [Срок оценки: 5 years]
• impact of treatment on self-reported future pregnancy/reproductive health [Срок оценки: 5 years]
• factors that influence decisions regarding fertility preservation [Срок оценки: 5 years]
• comparison of sexual function between breast cancer and lymphoma patients [Срок оценки: 5 years]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 7 центров

• Memorial Sloan Kettering Basking Ridge — Basking Ridge
• Memorial Sloan Kettering Monmouth — Middletown
• Memorial Sloan Kettering Bergen — Montvale
• Memorial Sloan Kettering Commack — Commack
• Memorial Sloan Kettering Westchester — Harrison
• Memorial Sloan Kettering Cancer Center — New York
• Memorial Sloan Kettering Nassau — Uniondale

Идентификаторы

NCT: NCT01788839 · 12-249

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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