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患有妇科和乳腺癌的育龄妇女不孕不育调查

2026年10月5日 更新者：M.D. Anderson Cancer Center

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.

研究概览

地位

主动，不招人

条件

干预/治疗

详细说明

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).

OUTLINE:

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.

研究类型

观察性的

注册 (估计的)

1410

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Texas
      • Houston、Texas、美国、77030
        • M D Anderson Cancer Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 45年 (成人)

接受健康志愿者

不

有资格学习的性别

女性

取样方法

非概率样本

研究人群

Women seen at the MD Anderson Oncofertility Clinic and Adolescent and Young Adult Program or women in the California Cancer Registry

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • FOCUS GROUP: Do not speak English or Spanish
  • SURVEY VALIDATION: Do not read and understand English
  • TELEPHONE SURVEY: Do not speak English or Spanish

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：COHORT
  • 时间观点：CROSS_SECTIONAL

队列和干预

团体/队列
干预/治疗
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.
其他：Survey Administration

Complete survey

行为的：Healthcare Activity

Attend focus group

其他名称：
  • 保健活动
  • 卫生保健

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Underlying constructs
大体时间：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.
Up to 3 years
Known-group validity
大体时间：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.
Up to 3 years
Convergent validity
大体时间：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.
Up to 3 years
Live birth
大体时间：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.
Up to 3 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

M.D. Anderson Cancer Center

调查人员

  • 首席研究员：Jose A Rauh-Hain、M.D. Anderson Cancer Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年4月1日

初级完成 (估计的)

2027年2月2日

研究完成 (估计的)

2027年2月2日

研究注册日期

首次提交

2020年12月16日

首先提交符合 QC 标准的

2020年12月16日

首次发布 (实际的)

2020年12月22日

研究记录更新

最后更新发布 (实际的)

2026年10月6日

上次提交的符合 QC 标准的更新

2026年10月5日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2018-0477
  • 2018-0477 (其他标识符：M D Anderson Cancer Center)
  • NCI-2020-08295 (注册表标识符：CTRP (Clinical Trial Reporting Program))

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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