Feasibility and Acceptability of a Fertility Preservation Decision Support Aid for Young Women with Cancer : An Intervention Development Pilot Study

Principal Investigators

Dates: 11/26/2013 – 5/26/2017

Co-Investigator:  Patricia Hershberger, Diana Wilkie, Jennifer Hirshfeld-Cytron

Abstract:  Advances in cancer diagnostics and treatments have redefined the focus of cancer from a treatment-based approach to a broader perspective encompassing survivorship and quality of life concerns. Despite these advances, many young women with cancer face infertility as a result of their cancer treatment. Until recently young women with cancer had no available treatment options to counteract the potential loss of fertility that can result from cancer therapy. However, advances in reproductive biotechnologies have made reproduction options such as oocyte, embryo, and ovarian tissue preservation available to young adult women with cancer that was unavailable to prior generations of women. Unfortunately, female fertility preservation treatments are complex and decisions about the emerging fertility preservation options for women with cancer often need to be made within weeks of a cancer diagnosis. Our prior research indicates that many women are overwhelmed by their cancer diagnosis at this time and desire assistance in navigating the decision-making process surrounding fertility preservation. Although there have been advances in decision support research, there is a wide gap in interventions that are aimed at assisting young women with cancer navigate the decision-making process surrounding fertility preservation treatment options. Building upon our prior qualitative research, the specific aim of this study is to determine the feasibility and acceptability of an educational, theoretically-based decision support intervention (DSI) and procedures for a randomized study. Using our successful recruitment approaches carried out in previous work, we propose a pilot study using a randomized, experimental two-group pre-test/post-test design among 10 young adult women with cancer. We aim to determine the feasibility and acceptability of the DSI and study procedures, and estimate the effect of the DSI compared to an attention control (e-Book). As indicators of protocol feasibility, we will assess recruitment, retention and missing data rates and the length of time required to complete the study. We will also collect quantitative (Computer Usability Instrument) and qualitative data about the acceptability of the interventions and procedures. We will also examine trends in pre-test/post-test change of the women's knowledge, intentions, and behaviors (measured with a modified SCKnowIQ) related to use of reproductive biotechnologies comparing the means and standard deviations on the knowledge, intention and behaviors scales pre-and post-intervention (DSI or e-Book). The findings from this study will provide preliminary evidence for a future NIH R01 application in which we will test the efficacy of the decision-support intervention.

IRSP – Internal Research Support Program