Family-building decision aid and planning tool for young adult women after cancer treatment: protocol for preliminary testing of a web-based decision support intervention in a single-arm pilot study
Family-building decision aid and planning tool for young adult women after cancer treatment: protocol for preliminary testing of a web-based decision support intervention in a single-arm pilot study
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DOI：
10.1136/bmjopen-2019-033630
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发表时间：
2019-12-01
期刊：
影响因子：
2.9
通讯作者：
Diefenbach, Michael
中科院分区：
文献类型：
--
作者：
Benedict, Catherine;Ford, Jennifer S.;Diefenbach, Michael
介绍许多年轻的成年女性（YA-F）癌症幸存者谁接受性腺毒性治疗将遇到生育问题。癌症后，生孩子通常需要辅助生殖技术（ART），代孕或收养。然而，在寻求这些选择方面存在着重大的信息、社会心理、财政和后勤障碍。幸存者报告说，与家庭建设决定有关的决策不确定性和痛苦率很高。本研究的目的是试点测试一个基于网络的决策援助和规划工具的家庭建设后cancer.Methods和analysis该试点研究将使用单臂试验设计，以测试的可行性和可接受性（目的1），并获得效果大小估计的决策支持干预（目的2）。目标样本量为100。参与者将包括YA-F幸存者（年龄18-45岁），他们正在接受治疗，尚未完成所需的家庭建设。将进行纵向预桩设计。参与者将在3个月的时间内完成三项心理社会评估调查，以跟踪决策冲突（主要结果）和认知，情感和行为功能（次要结果）。完成基线调查（T1;干预前）后，参与者将可以访问决策辅助网站。将在1个月（T2）和3个月（T3）随访时间点进行干预后调查。将分析可行性和可接受性指标。成对t检验将检验T1至T2的结局变量平均评分。将计算效应量估计值（Cohe's d）。Google Analytics将评估用户在研究期间对网站的参与度。基线和随访数据将检查可行性，可接受性和干预效果大小的措施。伦理和传播这将是第一次测试的支持性干预，以指导YA-F癌症幸存者在家庭建设的决定和早期规划。研究结果将为制定干预措施提供信息。未来的发展方向将包括一项随机对照试验，以测试更长时间内的干预效果。
Introduction Many young adult female (YA-F) cancer survivors who received gonadotoxic therapy will experience fertility problems. After cancer, having a child will often require assisted reproductive technology (ART), surrogacy or adoption. However, there are significant informational, psychosocial, financial and logistical barriers to pursuing these options. Survivors report high rates of decision uncertainty and distress related to family-building decisions. The aim of this study is to pilot test a web-based decision aid and planning tool for family-building after cancer.Methods and analysis The pilot study will use a single-arm trial design to test the feasibility and acceptability (aim 1) and obtain effect size estimates of the decision support intervention (aim 2). The target sample size is 100. Participants will include YA-F survivors (aged 18-45 years) who are post-treatment and have not completed desired family-building. A longitudinal prepost design will be conducted. Participants will complete three psychosocial assessment surveys over a 3-month time period to track decisional conflict (primary outcome) and cognitive, emotional, and behavioural functioning (secondary outcomes). After completing the baseline survey (T1; pre-intervention), participants will have access to the decision aid website. Postintervention surveys will be administered at 1-month (T2) and 3-month (T3) follow-up time points. Feasibility and acceptability metrics will be analysed. Pairwise t-tests will test mean scores of outcome variables from T1 to T2. Effect size estimates (Cohe's d) will be calculated. Google analytics will evaluate user engagement with the website over the study period. Baseline and follow-up data will examine measures of feasibility, acceptability and intervention effect size.Ethics and dissemination This will be the first test of a supportive intervention to guide YA-F cancer survivors in family-building decisions and early planning. Study findings will inform intervention development. Future directions will include a randomised controlled trial to test intervention efficacy over a longer time period.