RecruitingACTRN12621000515897

Evaluating fertility decision aids for younger women with breast cancer.

Evaluating the impact of a fertility decision aid developed using health literacy principles, compared to a gold-standard decision aid, on decision-related outcomes in younger women with breast cancer.

Sponsor

University of Melbourne

Enrollment

236 participants

Start Date

Jul 5, 2021

Study Type

Interventional

Conditions

Breast Cancer Fertility Preservation

Summary

This study aims to evaluate the impact of an online low health literacy fertility-related decision aid (DA) for young women with early breast cancer among women of all health literacy levels. The primary hypothesis is that the Intervention (DA website) is superior to the control (DA booklet), as measured by a greater reduction in decisional conflict at 12 months via the Decisional Conflict Scale. Who is it for? You may be eligible to take part in this study if you are a pre-menopausal woman aged between 18-40 years, have recently been diagnosed with early stage breast cancer, have not had an advanced cancer, have not undergone adjuvant therapy for breast cancer, want to find out more about fertility and/or fertility preservation at the time of diagnosis, and have easy access to the internet. Study details Participants will be randomly allocated (by chance) to receive either the new decision aid website or the existing decision aid booklet. The decision aid website contains easy-to-understand information about the side effects of cancer treatments on women's fertility, and options for preserving fertility to increase the chances of having a baby in the future. Participants will be asked to complete surveys at 4 timepoints: baseline (before viewing the DA), 1-month, 6-months, and 12-months after recruitment. We will then assess how effective the new DA is in supporting women to make decisions about breast cancer treatment and fertility. It is hoped that the DA will lead to better understanding of fertility-related issues and educated involvement in decision-making among women with diverse levels of health literacy.

Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 40 Yearss

Plain Language Summary

Simplified for easier understanding

Being diagnosed with breast cancer as a young woman raises urgent questions about fertility — chemotherapy and other treatments can affect the ability to have children in the future, and the window to take protective steps is short. Navigating these decisions while also processing a cancer diagnosis is overwhelming. This study tests whether a new online decision aid website is more helpful than an existing printed booklet in supporting young women to make informed fertility-related decisions. You may be eligible if you are a pre-menopausal woman aged 18 to 40, have recently been diagnosed with early-stage breast cancer (no advanced disease), have not yet started adjuvant therapy, and have easy access to the internet. Women who have already started fertility preservation are not eligible. Participants are randomly assigned to use either the website or the booklet, then complete surveys at baseline, 1 month, 6 months, and 12 months. The main measure is decisional conflict — how uncertain and unsupported women feel about their fertility decisions. The study aims to show that better information, presented in an accessible format, leads to more confident, informed choices for women with diverse levels of health literacy.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The intervention - Fertility Choices website - is an online decision aid (DA) specifically adapted for inclusivity of a low health literacy audience using low health literacy principles, to assist patients to reach an informed decision about fertility preservation. The DA has been developed in accordance with the latest International Patient Decision Aid Standards (IPDAS) established by a group of experts. The content is based on a literature review and consultation with experts, including health literacy experts, oncologists, breast surgeons, breast care nurses, reproductive health specialists, psychologists, behavioural scientists, and consumers. The DA includes information concerning the pros and cons of fertility preservation in women with early breast cancer and has evidence-based representation of chances of success. It addresses the complexity, uncertain benefits and potentially large costs in this setting. A summary of treatment procedures is presented with a set of values-clarification exercises to help weigh up the pros and cons of fertility preservation in light of patient values and life situation. Infographics and animations are also utilised to communicate topics and enhance understanding. The DA website has been pilot-tested among 23 pre-menopausal women aged between 18-40 years (ACTRN12615001364561) who were previously diagnosed with early-stage breast cancer, and was reported to be acceptable, helpful and easy-to-understand. The DA was subsequently modified according to feedback from the pilot testing. The updated DA website will be provided to women after completion of the baseline survey and randomisation. Each participant allocated to the DA website arm will receive an email/ letter with a link to access the website. Intervention adherence will be assessed by self-reported outcome, where patients will indicate if they have read the DA website (and how much of it) when completing the 1-Month survey.