Clinical trial NCT01788839: Longitudinal Sexual and Reproductive Health Study of Women with Breast Cancer and Lymphoma
Official title: Longitudinal Sexual and Reproductive Health Study of Women with Breast Cancer and Lymphoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lymphoma
Hodgkin's Lymphoma
Keywords: Sexual and Reproductive Health
premenopausal
postmenopausal
12-249
Fertility
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2013-02-11
Enrollment: 425
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

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

Primary outcomes:
measure: determine the natural history of sexual and reproductive health
timeFrame: 5 years
Secondary outcomes:
measure: predictors of sexual dysfunction during and after treatment
timeFrame: 5 years
measure: impact of treatment on self-reported future pregnancy/reproductive health
timeFrame: 5 years
measure: factors that influence decisions regarding fertility preservation
timeFrame: 5 years
measure: comparison of sexual function between breast cancer and lymphoma patients
timeFrame: 5 years
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
city: West Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Shari Goldfarb, MD
role: PRINCIPAL_INVESTIGATOR
References: