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

Recruiting

• Conditions: Breast Cancer; Lymphoma; Hodgkin's Lymphoma
• Interventions: Behavioral: surveys; Other: Blood draw; Device: Transvaginal ultrasounds

• Registration Number: NCT01788839
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-07
• Study First Submitted QC: 2013-02-07
• Study First Posted: 2013-02-11
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-23
• Last Update Posted: 2024-01-24
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 400

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
women with breast cancer	surveys	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	Transvaginal ultrasounds	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.
women with lymphoma	Blood draw	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.
women with breast cancer	Blood draw	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	surveys	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.
women with breast cancer	Transvaginal ultrasounds	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.

Primary Outcome Measures

Name	Time	Method
determine the natural history of sexual and reproductive health	5 years

Secondary Outcome Measures

Name	Time	Method
predictors of sexual dysfunction during and after treatment	5 years
comparison of sexual function between breast cancer and lymphoma patients	5 years
impact of treatment on self-reported future pregnancy/reproductive health	5 years
factors that influence decisions regarding fertility preservation	5 years	Before treatment and family building after treatment

Trial Locations

Locations (7)

Memorial Sloan Kettering Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Nassau; 🇺🇸 Uniondale, New York, United States

Memorial Sloan Kettering Monmouth; 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen; 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Commack; 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States