Family-building After Cancer: Preferences, Decisions, and Planning for Young Female Survivors

癌症后的家庭建设：年轻女性幸存者的偏好、决定和规划

• 批准号: 10573131
• 负责人: Catherine Benedict
• 金额: $ 14.01万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10573131
• 关键词: Address; Adoption; Aftercare; Age; Area; Assisted Reproductive Technology; Awareness; Cancer Survivor; Cancer Survivorship; Caring; Child; Clinical; Conflict (Psychology); Data; Decision Aid; Decision Making; Development; Devices; Distress; Eligibility Determination; Embryo; Emotional; Enrollment; Ensure; Evaluation; Family; Female; Fertility; Financial cost; Funding; Future; Goals; Health Technology; Human; Informal Social Control; Insurance; Interdisciplinary Study; Internet; Intervention; K-Series Research Career Programs; Knowledge; Lead; Legal; Malignant Neoplasms; Medical; Mentorship; Methodology; Modification; Motivation; Online Systems; Participant; Patients; Phase; Policies; Positioning Attribute; Pre-Post Tests; Procedures; Process; Public Health; Questionnaires; Reporting; Research; Research Design; Research Ethics; Research Personnel; Resources; Risk; Surveys; Survivors; Technology; Testing; Time; Training; Training Activity; Uncertainty; Woman; Work; acceptability and feasibility; arm; cancer therapy; chemotherapy; coping; cost; design; digital; digital communication; digital health; digital platform; efficacy trial; egg; evidence base; expectation; experience; fertility preservation; follow-up; health communication; human centered design; improved; interest; member; negative affect; oocyte cryopreservation; ovarian reserve; pilot test; pilot trial; preference; primary outcome; prototype; psychosocial; recruit; reproductive; satisfaction; secondary outcome; smartphone application; surrogacy; theories; therapy development; tool; usability; web based decision aid; web page; web site; web-based tool; young adult

PROJECT SUMMARY/ABSTRACT Many young adult female (YA-F) cancer survivors (18-39 years old) who received gonadotoxic therapy will experience fertility problems when trying to build a family and will need to use assisted reproductive technology (ART) or adoption to have children. However, there are significant informational, psychosocial, and financial barriers to ART and adoption. Lack of awareness, unrealistic expectations, distress, and avoidance or postponement of fertility care put YA-F survivors at-risk for being unable to have a child when they are ready or experiencing greater difficulty, medical or legal complications, distress, and higher costs during the process. To address this gap, the proposed project will develop and pilot test the first theoretically driven, evidence-based decision aid and planning tool for family-building after cancer. The interactive, web-based tool will help YA-Fs become informed, manage negative affect, and plan financially for future costs, thereby addressing key barriers to family-building after cancer, while inspiring hope that parenthood will be achieved. The study will be conducted in two phases. In Phase 1, we will develop a decision aid and planning tool using a responsive design website platform (Aim 1). First, a prototype will be designed based on a self-regulation framework, extensive pilot data, and with input from a multidisciplinary research team and Patient Research Partners. Then, we will conduct usability testing (n=10) to iteratively test and modify the prototype for usability, acceptability, and satisfaction. In Phase 2, we will conduct a single-arm pilot trial to evaluate the feasibility and acceptability of the tool and study procedures (Aim 2a) and to obtain effect size estimates for a large-scale trial involving the decision aid and planning tool (Aim 2b). A pre-post study design will be employed with questionnaire assessments at baseline (T1) and one and three month follow-up time points (T2 and T3). For Aim 2a, feasibility (rates of eligibility, enrollment, attrition, and reasons for refusal) and acceptability (web analytics, questionnaire completion rates) will be evaluated. For Aim 2b, effect size estimates will be calculated for reduction of decision conflict (primary outcome) and completion rate of an “action plan” module (secondary outcome). Changes in unmet information needs, reproductive concern, and financial capability, and in users’ confidence discussing fertility/family-building with others and motivation to take action will also be explored. Findings from this study will be used to lay the groundwork for designing an adequately powered efficacy trial (R01 submission), which Dr. Benedict will be well-prepared to lead after completing her training goals and the mentorship provided. The proposed career development award will allow Dr. Benedict to become an expert in digital health communication and technology-based intervention development and analysis within young adult cancer survivorship research, and support her becoming an independent investigator with R01-level funding.

项目总结/摘要 许多接受性腺毒性治疗的年轻成年女性（YA-F）癌症幸存者（18-39岁）将 在试图建立家庭时遇到生育问题，需要使用辅助生殖技术 (ART)或者收养孩子然而，有重要的信息，社会心理和财政 抗逆转录病毒治疗和采用的障碍。缺乏意识，不切实际的期望，痛苦和逃避或 推迟生育护理使YA-F幸存者处于无法生育的风险中，当他们准备好时， 在这一过程中遇到更大的困难、医疗或法律的并发症、痛苦和更高的费用。到 为了解决这一差距，拟议的项目将开发和试点测试第一个理论驱动的，以证据为基础的 癌症后家庭建设的决策援助和规划工具。这个基于网络的交互式工具将帮助YA-F 了解情况，管理负面影响，并为未来的成本进行财务计划，从而解决关键问题， 这一倡议消除了癌症后建立家庭的障碍，同时激发了人们成为父母的希望。本研究将 分两个阶段进行。在第一阶段，我们将开发一个决策辅助和规划工具， 设计网站平台（目标1）。首先，将根据自我监管框架设计原型， 广泛的试点数据，并从多学科研究团队和患者研究合作伙伴的投入。 然后，我们将进行可用性测试（n=10），以迭代地测试和修改原型的可用性， 可接受性和满意度。在第二阶段，我们将进行一项单组试点试验，以评估可行性， 工具和研究程序的可接受性（目标2a），并获得大规模试验的效应量估计值 涉及决策辅助和规划工具（目标2b）。将采用前后研究设计， 在基线（T1）和1个月和3个月随访时间点（T2和T3）进行问卷评估。为 目标2a，可行性（合格率、入组率、自然减员率和拒绝理由）和可接受性（网络 分析，问卷完成率）进行评估。对于目标2b，将计算效应量估计值 减少决策冲突（主要结果）和“行动计划”模块的完成率（次要结果 结果）。未得到满足的信息需求、生殖问题和财政能力以及用户 还将探讨与他人讨论生育/家庭建设的信心和采取行动的动机。 这项研究的结果将用于为设计一项具有充分把握度的疗效试验奠定基础 (R01提交），本尼迪克特博士将在完成培训目标和 提供指导。拟议中的职业发展奖将使本尼迪克特博士成为一个专家， 数字健康传播和基于技术的干预措施的开发和分析 癌症生存研究，并支持她成为一个独立的研究者与R 01级的资金。

项目成果

Development of a Web-Based Decision Aid and Planning Tool for Family Building After Cancer (Roadmap to Parenthood): Usability Testing.

• DOI: 10.2196/33304
• 发表时间: 2022-05-31
• 期刊: JMIR cancer
• 影响因子: 2.8

"Looking at future cancer survivors, give them a roadmap": addressing fertility and family-building topics in post-treatment cancer survivorship care.

• DOI: 10.1007/s00520-020-05731-3
• 发表时间: 2021-04
• 期刊: Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer
• 作者: Benedict C;Nieh JL;Hahn AL;McCready A;Diefenbach M;Ford JS
• 通讯作者: Ford JS

A Decision Aid Intervention for Family Building After Cancer: Developmental Study on the Initial Steps to Consider When Designing a Web-Based Prototype.

• DOI: 10.2196/20841
• 发表时间: 2021-01-22
• 期刊: JMIR formative research
• 影响因子: 2.2
• 作者: Benedict C;Dauber-Decker KL;King D;Hahn A;Ford JS;Diefenbach M
• 通讯作者: Diefenbach M