PDF(Pubmed)
Abstract：
With the increase in the number of long-term survivors, interest is shifting from cancer survival to life and quality of life after cancer. These include consequences of long-term side effects of treatment, such as gonadotoxicity. Fertility preservation is becoming increasingly important in cancer management. International recommendations agree on the need to inform patients prior to treatments about the risk of fertility impairment and refer them to specialized centers to discuss fertility preservation. However, the literature reveals suboptimal access to fertility preservation on an international scale, and particularly in France, making information for patients and oncologists a potential lever for action. Our overall goal is to improve access to fertility preservation consultations for women with breast cancer through the development and evaluation of a combined intervention targeting the access and diffusion of information for these patients and brief training for oncologists.
Firstly, we will improve existing information tools and create brief training content for oncologists using a qualitative, iterative, user-centred and participatory approach (objective 1). We will then use these tools in a combined intervention to conduct a stepped-wedge cluster randomized trial (objective 2) including 750 women aged 18 to 40 newly treated with chemotherapy for breast cancer at one of the 6 participating centers. As the primary outcome of the trial will be the access to fertility preservation counselling before and after using the combined intervention (brochures and brief training for oncologists), we will compare the rate of fertility preservation consultations between the usual care and intervention phases using linear regression models. Finally, we will analyse our approach using a context-sensitive implementation analysis and provide key elements for transferability to other contexts in France (objective 3).
We expect to observe an increase in access to fertility preservation consultations as a result of the combined intervention. Particular attention will be paid to the effect of this intervention on socially disadvantaged women, who are known to be at greater risk of inappropriate treatment. The user-centred design principles and participatory approaches used to optimize the acceptability, usability and feasibility of the combined intervention will likely enhance its impact, diffusion and sustainability.
Registry: ClinicalTrials.gov.
NCT05989776. Date of registration: 7th September 2023. URL: https://classic.
gov/ct2/show/NCT05989776 .
Manuscript based on study protocol version 2.0, 21st may 2023.
Firstly, we will improve existing information tools and create brief training content for oncologists using a qualitative, iterative, user-centred and participatory approach (objective 1). We will then use these tools in a combined intervention to conduct a stepped-wedge cluster randomized trial (objective 2) including 750 women aged 18 to 40 newly treated with chemotherapy for breast cancer at one of the 6 participating centers. As the primary outcome of the trial will be the access to fertility preservation counselling before and after using the combined intervention (brochures and brief training for oncologists), we will compare the rate of fertility preservation consultations between the usual care and intervention phases using linear regression models. Finally, we will analyse our approach using a context-sensitive implementation analysis and provide key elements for transferability to other contexts in France (objective 3).
We expect to observe an increase in access to fertility preservation consultations as a result of the combined intervention. Particular attention will be paid to the effect of this intervention on socially disadvantaged women, who are known to be at greater risk of inappropriate treatment. The user-centred design principles and participatory approaches used to optimize the acceptability, usability and feasibility of the combined intervention will likely enhance its impact, diffusion and sustainability.
Registry: ClinicalTrials.gov.
NCT05989776. Date of registration: 7th September 2023. URL: https://classic.
gov/ct2/show/NCT05989776 .
Manuscript based on study protocol version 2.0, 21st may 2023.
摘要：
背景：随着长期幸存者数量的增加，兴趣正在从癌症生存转移到癌症后的生活和生活质量。这些包括治疗的长期副作用的后果，如性腺毒性。保留生育力在癌症管理中变得越来越重要。国际建议同意需要在治疗前告知患者生育能力受损的风险，并将他们转介给专门的中心讨论保留生育能力。然而,文献揭示了在国际范围内获得生育力保护的次优机会，尤其是在法国，使患者和肿瘤学家的信息成为行动的潜在杠杆。我们的总体目标是通过开发和评估针对这些患者的信息获取和传播以及对肿瘤学家的简短培训的联合干预措施，来改善患有乳腺癌的妇女获得生育力保护咨询的机会。
方法：首先，我们将改进现有的信息工具，并使用定性、迭代，以用户为中心和参与式方法(目标1)。然后，我们将在联合干预中使用这些工具进行阶梯式楔形集群随机试验（目标2），包括在6个参与中心之一接受乳腺癌化疗的750名18至40岁女性。由于试验的主要结果是在使用联合干预措施之前和之后获得生育力保存咨询（对肿瘤学家的手册和简短培训），我们将使用线性回归模型比较常规护理和干预阶段之间的生育率保留咨询率。最后,我们将使用上下文相关的实施分析来分析我们的方法，并提供可转移到法国其他上下文的关键要素（目标3）。
结论：我们预计，由于综合干预措施，获得保留生育能力咨询的机会会增加。将特别注意这一干预措施对社会弱势妇女的影响，已知有更大的不适当治疗风险。以用户为中心的设计原则和用于优化可接受性的参与式方法，综合干预措施的可用性和可行性可能会增强其影响，扩散和可持续性。
背景：注册表：ClinicalTrials.gov.
背景：NCT05989776。注册日期：2023年9月7日。URL：https://classic。
结果：gov/ct2/show/NCT05989776。
方法：基于2023年5月21日的研究协议版本2.0的手稿。
方法：首先，我们将改进现有的信息工具，并使用定性、迭代，以用户为中心和参与式方法(目标1)。然后，我们将在联合干预中使用这些工具进行阶梯式楔形集群随机试验（目标2），包括在6个参与中心之一接受乳腺癌化疗的750名18至40岁女性。由于试验的主要结果是在使用联合干预措施之前和之后获得生育力保存咨询（对肿瘤学家的手册和简短培训），我们将使用线性回归模型比较常规护理和干预阶段之间的生育率保留咨询率。最后,我们将使用上下文相关的实施分析来分析我们的方法，并提供可转移到法国其他上下文的关键要素（目标3）。
结论：我们预计，由于综合干预措施，获得保留生育能力咨询的机会会增加。将特别注意这一干预措施对社会弱势妇女的影响，已知有更大的不适当治疗风险。以用户为中心的设计原则和用于优化可接受性的参与式方法，综合干预措施的可用性和可行性可能会增强其影响，扩散和可持续性。
背景：注册表：ClinicalTrials.gov.
背景：NCT05989776。注册日期：2023年9月7日。URL：https://classic。
结果：gov/ct2/show/NCT05989776。
方法：基于2023年5月21日的研究协议版本2.0的手稿。
