Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 475
- 试验地点
- 12
- 主要终点
- determine the natural history of sexual and reproductive health
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: surveys (Behavioral)
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.
干预措施: Blood draw (Other)
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.
干预措施: Transvaginal ultrasounds (Device)
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.
干预措施: Blood draw (Other)
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.
干预措施: surveys (Behavioral)
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.
干预措施: Transvaginal ultrasounds (Device)
结局指标
主要结局
determine the natural history of sexual and reproductive health
时间窗: 5 years
次要结局
- impact of treatment on self-reported future pregnancy/reproductive health(5 years)
- predictors of sexual dysfunction during and after treatment(5 years)
- comparison of sexual function between breast cancer and lymphoma patients(5 years)
- factors that influence decisions regarding fertility preservation(5 years)