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Questionnaires in Describing the Natural History of Reproductive and Sexual Health in Patients with Stage 0-III Breast Cancer or Aggressive Lymphoma
Trial Status: active
This research trial studies questionnaires in describing the natural history of reproductive and sexual health in patients with stage 0-III breast cancer or lymphoma that forms, grows, or spreads quickly. Gathering health information over time from patients with stage 0-III breast cancer or aggressive lymphoma may help doctors learn which patients will be more likely to have early menopause, develop sexual problems during treatment, and have difficulty getting pregnant after treatment.
Inclusion Criteria
COHORT OF PREMENOPAUSAL: Women, 18 years of age and older
COHORT OF PREMENOPAUSAL: Premenopausal 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
COHORT OF PREMENOPAUSAL: 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
COHORT OF PREMENOPAUSAL: Breast cancer patients with any receptor type
COHORT OF PREMENOPAUSAL: English speaking
COHORT OF PREMENOPAUSAL: Able to participate in the informed consent process
TAMOXIFEN ONLY SUBSET OF COHORT OF PREMENOPAUSAL: Women, 18 years of age and older
TAMOXIFEN ONLY SUBSET OF COHORT OF PREMENOPAUSAL: Premenopausal 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
TAMOXIFEN ONLY SUBSET OF COHORT OF PREMENOPAUSAL: 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
TAMOXIFEN ONLY SUBSET OF COHORT OF PREMENOPAUSAL: Breast cancer patients with any receptor type
TAMOXIFEN ONLY SUBSET OF COHORT OF PREMENOPAUSAL: English speaking
TAMOXIFEN ONLY SUBSET OF COHORT OF PREMENOPAUSAL: Able to participate in the informed consent process
POSTMENOPAUSAL: Women, 18 years of age and older
POSTMENOPAUSAL: Postmenopausal at time of diagnosis who have been without a period for >= 2 years
POSTMENOPAUSAL: 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
POSTMENOPAUSAL: Breast cancer patients with any receptor type
POSTMENOPAUSAL: English speaking
POSTMENOPAUSAL: Able to participate in the informed consent process
Exclusion Criteria
Active secondary cancer requiring cytotoxic chemotherapy
Prior systemic treatment for a malignancy
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01788839.
Locations matching your search criteria
United States
New Jersey
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Shari Beth Goldfarb
Phone: 646-888-5080
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Shari Beth Goldfarb
Phone: 646-888-5080
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Shari Beth Goldfarb
Phone: 646-888-5080
New York
Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Shari Beth Goldfarb
Phone: 646-888-5080
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Shari Beth Goldfarb
Phone: 646-888-5080
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Shari Beth Goldfarb
Phone: 646-888-5080
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Shari Beth Goldfarb
Phone: 646-888-5080
PRIMARY OBJECTIVE:
I. Describe the natural history of sexual and reproductive health, including the prevalence, severity and trajectory of sexual dysfunction, in a cohort of breast cancer and lymphoma patients being followed from diagnosis through treatment and into survivorship.
OUTLINE: This is an observational study.
Patients complete questionnaires to assess sexual life, prior menstrual history, fertility and other medical conditions for 15-20 minutes at baseline, 3 and 6 months, 1 year, and then yearly for 4 years. Patients also undergo blood sample collection and may undergo transvaginal ultrasound on study.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationMemorial Sloan Kettering Cancer Center