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.

项目概要/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： 中度至重度与生育相关的创伤，性腺毒性癌症治疗可能会导致早期不育。 更年期，或癌症后怀孕和怀孕至足月的问题。 需要体外受精、代孕或收养，其中涉及医疗/身体、社会心理、财务、法律、 之前的工作表明，YA-F 没有准备好应对之后建立家庭的挑战。 癌症，有不切实际的期望（例如高估成功的可能性），并且有错过机会的风险 生育窗口缩小，并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的肿瘤生育护理。 建议测试“为人父母路线图”软件的功效，这是一种基于网络的交互式决策辅助工具 YA-F 幸存者（18-45 岁；出生时指定为女性）的癌症后家庭建设规划工具 首先，我们将进行严格的 12 个月随机对照试验。 （目标 1）。YA-F 癌症幸存者 (N=256) 将被随机分配到 (a) 路线图干预条件或 (b) 组中。 时间和注意力控制条件，包括基于网络的年轻人癌症生存信息 调查将在基线（干预前）和 1、6 和 12 个月的随访中进行。 与对照组相比，我们开创的干预组会报告较低的决策。 关于家庭建设的冲突（主要成果），更多的规划行为与家庭建设目标相一致 （例如，生育测试、财务规划）和生活质量的改善（次要结果）。 干预效果的中介因素和调节因素（目标 2）我们寻求年龄、伴侣状况、生育能力。 保存历史，参与决策援助将缓和两者之间的关系 干预和决策冲突，知识水平和自我效能感的提高以及改善 与提供者的沟通会调解决策冲突的干预效果。 路线图工具在临床环境中的未来实施潜力（目标 3）。 机会动机行为（COM-B）实施模型，我们将进行定性访谈 代表四个专业的提供者（N = 32；每个专业 8 个）来了解阻碍和促进因素 跨诊所实施路线图工具，在肿瘤学、基层医疗等不同环境中工作。 护理、妇科和生殖医学，所有这些领域都在临床上解决生殖健康问题， 包括与“能力”类别中的障碍/促进因素相关的主题（例如技能、知识）， 这项研究将确定“机会”（例如资源）和“动机”（例如情感、信念）。 全面满足癌症后希望生孩子的 YA-F 幸存者的已确定需求 通过一种新颖的干预措施，为决策和早期规划提供信息和支持。