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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Device, Behavioral, Other
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

‣ 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

Locations
United States
New Jersey
Memorial Sloan Kettering Basking Ridge
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth
RECRUITING
Middletown
Memorial Sloan Kettering Bergen
RECRUITING
Montvale
New York
Memorial Sloan Kettering Commack
RECRUITING
Commack
Memorial Sloan Kettering Westchester
RECRUITING
East White Plains
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Memorial Sloan Kettering Nassau
RECRUITING
Uniondale
Contact Information
Primary
Shari Goldfarb, MD
646-888-5080
Backup
Jeanne Carter, MD
646-888-5076
Time Frame
Start Date: 2013-02
Estimated Completion Date: 2026-02
Participants
Target number of participants: 425
Treatments
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. In the case that participants miss the follow up questionnaires, study staff may contact the patient by phone to request and record the patients responses. The study staff may also mail the missed questionnaires to each patient.
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. In the case that participants miss the follow up questionnaires, study staff may contact the patient by phone to request and record the patients responses. The study staff may also mail the missed questionnaires to each patient.
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov