Tuesday, April 23, 2024
4/23/2024
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.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).
