Woodard Terri Lynn, Hoffman Aubri S, Crocker Laura C, Holman Deborah A, Hoffman Derek B, Ma Jusheng, Bassett Roland L, Leal Viola B, Volk Robert J
Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Baylor College of Medicine, Houston, Texas, USA.
BMJ Open. 2018 Feb 21;8(2):e019994. doi: 10.1136/bmjopen-2017-019994.
National guidelines recommend that all reproductive-age women with cancer be informed of their fertility risks and offered referral to fertility specialists to discuss fertility preservation options. However, reports indicate that only 5% of patients have consultations, and rates of long-term infertility-related distress remain high. Previous studies report several barriers to fertility preservation; however, initial success has been reported using provider education, patient decision aids and navigation support. This protocol will test effects of a multicomponent intervention compared with usual care on women's fertility preservation knowledge and decision-making outcomes.
This cluster-randomised trial will compare the multicomponent intervention (provider education, patient decision aid and navigation support) with usual care (consultation and referral, if requested). One hundred newly diagnosed English-speaking women of reproductive age who are at risk of cancer-related infertility will be recruited from four regional oncology clinics.The patient decision aid website provides (1) up-to-date evidence and descriptions of fertility preservation and other family-building options, tailored to cancer type; (2) structured guidance to support personalising the information and informed decision-making; and (3) a printable summary to help women prepare for discussions with their oncologist and/or fertility specialist. Four sites will be randomly assigned to intervention or control groups. Participants will be recruited after their oncology consultation and asked to complete online questionnaires at baseline, 1 week and 2 months to assess their demographics, fertility preservation knowledge, and decision-making process and quality. The primary outcome (decisional conflict) will be tested using Fisher's exact test. Secondary outcomes will be assessed using generalised linear mixed models, and sensitivity analyses will be conducted, as appropriate.
The University of Texas MD Anderson Cancer Center provided approval and ongoing review of this protocol. Results will be presented at relevant scientific meetings and submitted for publication in a peer-reviewed journal.
NCT03141437; Pre-results.
国家指南建议，应告知所有患有癌症的育龄妇女其生育风险，并转介至生育专家处，以讨论生育力保存方案。然而，报告显示只有5%的患者进行了咨询，长期不孕相关困扰的发生率仍然很高。先前的研究报告了生育力保存存在的几个障碍；不过，据报道，通过提供者教育、患者决策辅助工具和导航支持已取得初步成功。本方案将测试一种多组分干预措施与常规护理相比，对女性生育力保存知识和决策结果的影响。
本整群随机试验将多组分干预措施（提供者教育、患者决策辅助工具和导航支持）与常规护理（如有需要，进行咨询和转介）进行比较。将从四个地区肿瘤诊所招募100名新诊断的、有患癌症相关不孕风险的英语育龄妇女。患者决策辅助网站提供：（1）根据癌症类型量身定制的生育力保存及其他生育选择的最新证据和描述；（2）支持将信息个性化并做出明智决策的结构化指导；（3）一份可打印的摘要，以帮助女性为与肿瘤学家和/或生育专家的讨论做准备。四个地点将被随机分配到干预组或对照组。参与者将在肿瘤咨询后招募，并被要求在基线、1周和2个月时完成在线问卷，以评估其人口统计学特征、生育力保存知识以及决策过程和质量。主要结局（决策冲突）将使用Fisher精确检验进行测试。次要结局将使用广义线性混合模型进行评估，并在适当时进行敏感性分析。
德克萨斯大学MD安德森癌症中心已批准并持续审查本方案。结果将在相关科学会议上公布，并提交至同行评审期刊发表。
NCT03141437；预结果。
