None listed
Conditions
Brief summary
The primary purpose of this study is to develop and evaluate a new low literacy decision aid relating to fertility preservation for younger women with early stage breast cancer. Who is it for? You may be eligible to join this study if you are a pre-menopausal woman aged 18 to 40 years of age, who has been diagnosed with early stage breast cancer with no history of metastatic disease, and was interested in finding out more about fertility and/or fertility preservation at the time of diagnosis. Study details Participants in this study will be randomly selected (by chance) to receive either usual care or to access the decision aid website. The decision aid includes easy to understand information regarding the side effects of cancer treatments in terms of their effects on women's fertility, and options for preserving fertility to increase chances of having a baby at a later date. Participants will then be asked to fill out a questionnaire before seeing the decision aid website, and also a questionnaire regarding the choices made and the use of the decision aid after one month, 6 months and again after one year. It is hoped that the findings of this trial will provide information on how helpful fertility preservation information is to women with early stage breast cancer, and to improve access to this information by women as part of their medical care going forward.
Interventions
The intervention is a low-literacy decision aid (DA) designed 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 will be based on a literature review and consultation with experts, including health literacy experts, oncologists, breast surgeons, breast care nurses, reproductive health specialists, psychologists, be
The intervention is a low-literacy decision aid (DA) designed 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 will be 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 are 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. The format of the DA will be a website. The DA will be provided to women after the completion of the baseline questionnaire.
Sponsors
University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
To be eligible to participate women must: a) be aged between 18-40 years (inclusive) at the time of diagnosis b) histologically confirmed diagnosis of early-stage breast cancer c) pre-menopausal at time of diagnosis, d) have no history of metastatic disease prior to diagnosis, e) interested in finding out more about fertility and/or fertility preservation at the time of diagnosis f) able to give informed consent g) have easy access to the internet
Exclusion criteria
Although women whose primary language is other than English (LOTE) will not explicitly be excluded, women will need to have enough English capability to complete the questionnaires and communicate with the researchers. Should the oncologist consider the patient’s English skills to be insufficient, they will be excluded.
Outcome results
None listed