Infertility Survey Among Reproductive Age Women With Gynecological and Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,410
- 试验地点
- 1
- 主要终点
- Known-group validity
研究概览
简要总结
This study develops infertility survey among reproductive age women with gynecological and breast cancer. This study aims to learn how women consider whether or not to try to have a baby after surviving cancer. The advice gathered from this survey may be shared with patients and survivors in the future, so that they have information to inform their decisions about cancer treatment and family planning.
详细描述
PRIMARY OBJECTIVES:
I. To tailor the National Fertility Barriers (NFB) Survey for women who have had gynecological and breast cancers.
II. To administer the tailored survey and evaluate if utilization of infertility clinics and treatments is associated with pregnancies leading to live births after gynecological or breast cancer.
SECONDARY OBJECTIVE:
I. To evaluate whether potential covariates are associated with utilization of infertility clinics and live births after gynecological and breast cancers (e.g. socio-demographic, clinical, psychological, lifestyle, and decision-making characteristics).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •FOCUS GROUP: Women seen at the MD Anderson Oncofertility Clinic and Adolescent and Young Adult Program who are 18-45 years old at the time of cancer diagnosis
- •SURVEY VALIDATION: Women seen at the MD Anderson Oncofertility Clinic and Adolescent and Young Adult Program who are 18-45 years old at the time of cancer diagnosis
- •TELEPHONE SURVEY: Women in the California Cancer Registry
- •TELEPHONE SURVEY: Are 18-45 years old
- •TELEPHONE SURVEY: Were diagnosed with early-stage ovarian (IA and IC), endometrial (IA), cervical (IA1-IB1), or breast cancer (I-III)
- •TELEPHONE SURVEY: Are 5-12 years post diagnosis between the years of 2007-2014
- •TELEPHONE SURVEY: Underwent fertility-preservation treatments
排除标准
- •FOCUS GROUP: Do not speak English or Spanish
- •SURVEY VALIDATION: Do not read and understand English
- •TELEPHONE SURVEY: Do not speak English or Spanish
研究组 & 干预措施
Observational (focus group, survey)
FOCUS GROUP: Patients attend an audiotaped focus group over 90 minutes to provide feedback for survey development.
SURVEY VALIDATION: Patients complete an online survey over 15-30 minutes at baseline and 2 days later.
TELEPHONE SURVEY: Patients complete a telephone survey.
干预措施: Healthcare Activity (Behavioral)
Observational (focus group, survey)
FOCUS GROUP: Patients attend an audiotaped focus group over 90 minutes to provide feedback for survey development.
SURVEY VALIDATION: Patients complete an online survey over 15-30 minutes at baseline and 2 days later.
TELEPHONE SURVEY: Patients complete a telephone survey.
干预措施: Survey Administration (Other)
结局指标
主要结局
Known-group validity
时间窗: Up to 3 years
Will use t-test to compare two groups. If the distributional assumptions are not met, will use the Mann Whitney test.
Underlying constructs
时间窗: Up to 3 years
Will be measured by the Oncofertility Barriers Scale. Will perform factor analysis using principal axis factoring with oblique rotation to simplify the construct interpretation.
Live birth
时间窗: Up to 3 years
Will compare cancer diagnosis, treatment characteristics and patient reported survey results by live birth (yes versus no) using a 2-sample t-test (or Wilcoxon depending on underlying distribution) and chi-squared test (or Fisher's exact test). Will also conduct logistic regression analysis regressing live birth on predictors of interest, and build a multivariable model based on univariate results including all terms significant at the 0.10 level then refining the model using backwards selection to include variables significant at the 0.05 level in the final model.
Convergent validity
时间窗: Up to 3 years
Will correlate Oncofertility Barriers Scale scores with Evaluation and Nurturing Relationship Issues, Communication and Happiness scores. Analysis of variance will be used to generate a generalizability coefficient for relevant factors, as distributions allow. As distributions allow, will also assess a priori hypotheses that divergence will be observed among groups of women with different ages, cancer types, time since completing cancer treatment, and priori fertility concerns, as well as access to and utilization of fertility care. All tests will be two-sided and use a significance level of 0.05.
次要结局
未报告次要终点