Testing the efficacy of a decision aid and planning tool for family building after cancer

测试癌症后家庭建设决策辅助和规划工具的功效

• 批准号: 10715548
• 负责人: Catherine Benedict
• 金额: $ 63.29万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-08 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10715548
• 关键词: Address; Adoption; Aftercare; Age; Area; Assisted Reproductive Technology; Behavior; Behavioral Mechanisms; Behavioral Model; Belief; Cancer Survivor; Cancer Survivorship; Caring; Categories; Child; Clinic; Clinical; Communication; Computer software; Conflict (Psychology); Continuance of life; Control Groups; Counseling; Data; Decision Aid; Decision Making; Distress; Emotional; Emotions; Ensure; Family; Female; Fertility; Fertilization in Vitro; Future; Generations; Goals; Gynecology; High-Risk Cancer; Infertility; Intervention; Intervention Trial; Interview; Knowledge; Legal; Malignant Neoplasms; Mediating; Mediator; Medical; Mission; Modeling; Motivation; Oncology; Online Systems; Pamphlets; Patients; Pilot Projects; Pregnancy; Premature Menopause; Primary Care; Provider; Quality of life; Randomized; Randomized, Controlled Trials; Recommendation; Recording of previous events; Reporting; Reproductive Health; Reproductive Medicine; Research; Resources; Risk; Self Efficacy; Surveys; Survivors; Testing; Time; Trauma; Treatment Efficacy; United States National Institutes of Health; Woman; Work; acceptability and feasibility; assigned female at birth; attentional control; cancer therapy; comparison control; cost; efficacy testing; efficacy trial; expectation; experience; family building; fertility preservation; follow-up; future implementation; group intervention; implementation facilitators; implementation intervention; improved; intervention effect; medical specialties; novel; oncofertility; patient-clinician communication; pilot test; preference; pregnant; primary outcome; provider communication; psychosocial; reproductive; secondary outcome; skills; success; surrogacy; survivorship; therapy development; tool; web based decision aid; young adult

Project Summary/Abstract Up to 93% of young adult female (YA-F) cancer survivors report fertility distress; 30-46% meet criteria for moderate-severe fertility-related trauma. Gonadotoxic cancer treatments can cause infertility, early menopause, or problems getting pregnant and carrying a pregnancy to term. Family building after cancer often requires in vitro fertilization, surrogacy, or adoption, which have medical/physical, psychosocial, financial, legal, and logistical barriers. Prior work shows that YA-Fs are unprepared for the challenges of family building after cancer, have unrealistic expectations (such as overestimating the likelihood of success), and risk missing their narrowed reproductive window and experiencing greater difficulty, distress, and higher costs than expected. The long-term goal of the proposed research is to improve oncofertility care in post-treatment survivorship. We propose to test the efficacy of the Roadmap to Parenthood software, an interactive web-based decision aid and planning tool for family building after cancer for YA-F survivors (18-45 years old; assigned female at birth) and explore its implementation potential. First, we will conduct a rigorous 12-month randomized controlled trial (Aim 1). YA-F cancer survivors (N=256) will be randomized into the (a) Roadmap intervention condition or (b) time and attention control condition that includes a web-based young adult cancer survivorship informational booklet. Surveys will be administered at baseline (pre-intervention) and 1-, 6-, and 12-month follow up timepoints. We hypothesize the intervention group compared to the control group will report lower decisional conflict about family building (primary outcome), more planning behaviors aligned with family-building goals (e.g., fertility testing, financial planning), and improved quality of life (secondary outcomes). Then, we will test mediators and moderators of intervention efficacy (Aim 2). We hypothesize age, partnership status, fertility preservation history, and engagement with the decision aid will moderate the relationship between the intervention and decisional conflict, and increased levels of knowledge and self-efficacy and improved communication with providers will mediate the intervention effect on decisional conflict. Finally, we will evaluate future implementation potential of the Roadmap tool in clinical settings (Aim 3). Guided by the Capability- Opportunity-Motivation Behavior (COM-B) implementation model, we will conduct qualitative interviews with providers representing four specialties (N=32; 8 from each) to understand barriers and facilitators to the implementation of the Roadmap tool across clinics. Providers working in diverse settings in oncology, primary care, gynecology, and reproductive medicine, all of whom address reproductive health clinically, will be included. Themes related to barriers/facilitators within the categories of ‘capability’ (e.g., skills, knowledge), ‘opportunity’ (e.g., resources), and ‘motivation’ (e.g., emotion, beliefs) will be identified. This research will comprehensively respond to the identified needs of YA-F survivors that hope to have a child after cancer through a novel intervention that provides information and support for decision making and early planning.

项目总结/摘要 高达93%的年轻成年女性（YA-F）癌症幸存者报告生育困难; 30-46%符合以下标准： 中重度生育相关创伤性腺毒性癌症治疗可导致不孕症，早期 更年期，或怀孕和怀孕到足月的问题。癌症后的家庭建设往往 需要体外受精，代孕，或收养，这有医疗/身体，心理，财务，法律的， 后勤障碍。先前的研究表明，青年女性在经历了一段时间的家庭建设之后， 癌症，有不切实际的期望（如高估成功的可能性），并有错过他们的风险。 生殖窗口缩小，经历比预期更大的困难、痛苦和更高的成本。 拟议研究的长期目标是改善治疗后生存率的肿瘤生育护理。我们 我建议测试父母身份路线图软件的有效性，这是一个基于网络的交互式决策辅助工具 为YA-F幸存者（18-45岁;出生时指定为女性）提供的癌症后家庭建设规划工具 并探索其实施潜力。首先，我们将进行一项为期12个月的严格随机对照试验 (Aim 1）。YA-F癌症幸存者（N=256）将被随机分配至（a）路线图干预条件或（B） 时间和注意力控制条件，包括基于网络的年轻成人癌症生存信息 小册子。将在基线（干预前）和1个月、6个月和12个月随访时进行调查 时间点。我们假设干预组与对照组相比， 关于家庭建设的冲突（主要结局），更多的计划行为与家庭建设目标一致 (e.g.,生育测试、财务规划）和改善生活质量（次要结果）。然后，我们将测试 干预效果的中介者和调节者（目标2）。我们假设年龄，伴侣关系，生育能力 保存历史以及与决策辅助的参与将缓和 干预和决策冲突，提高知识水平和自我效能， 与提供者沟通对决策冲突的干预效果起中介作用。最后，我们将评估 路线图工具在临床环境中的未来实施潜力（目标3）。以能力为导向， 我们将进行定性访谈， 代表四个专业的供应商（N=32;每个专业8名），以了解 路线图工具在各诊所的实施。在不同环境中工作的提供者，主要 护理，妇科和生殖医学，所有这些都涉及生殖健康临床，将是 包括.与“能力”类别中的障碍/促进因素有关的主题（例如，技能、知识）， “机会”（例如，资源）和“动机”（例如，情感、信念）将被识别。这项研究将 全面回应希望在癌症后生育孩子的YA-F幸存者的明确需求 通过一种新的干预措施，为决策和早期规划提供信息和支持。