None listed
Conditions
Brief summary
Each year approximately 10,000 women are diagnosed with breast cancer in Australia, making this the most frequently diagnosed cancer in reproductive age women. Approximately 6-7% of these women are under 40 years at the time of their diagnosis. All patients faced with decisions about treatment for cancer need to weigh up the benefits and side-effects of treatment. This issue is particularly relevant in considering the effects of treatment on future fertility. The prognosis in terms of survival for young women is often excellent, but permanent ovarian failure and hence infertility as a result of adjuvant chemotherapy is a common consequence. For many young women, this is of enormous importance. Yet, many are not fully informed of the potential adverse reproductive effects of chemotherapy or fail to take in the possible consequences of treatment while making treatment decisions shortly after the diagnosis of breast cancer. Our objective is to conduct a comprehensive nation-wide prospective study to compare the efficacy of a fertility-related decision aid (an information tool specifically designed to assist with decision-making) to usual care amongst young women with early breast cancer. The decision aid will present information on choice of chemotherapeutic agents, Assisted Reproductive Technology (ART) options and the impact of pregnancy following diagnosis on prognosis. Following pilot-testing, the decision aid will be tested in a prospective nationwide study involving 17 oncology clinics, and young women with early breast cancer will be recruited prior to commencement of any adjuvant therapy. Data will be collected prior to commencement of adjuvant therapy, and 1 and 12 months following this, using self-administered questionaries assessing a range of variables, using validated measures of psychological and decision-related outcomes.
Interventions
Women will be recruited prospectively prior to the commencement of any adjuvant therapy through 22 oncology clinics nation-wide. During the first year of recruitment, women will be given an information booklet developed by the National Breast Cancer Centre for consumers (control). In the second year of recruitment women will be given the decision aid (an information tool desigened to assist with decision making).
Sponsors
Bettina Meiser
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
Women at time of diagnosis of a histologically confirmed early-stage breast cancer; pre-menopausal at time of diagnosis and not having completed their families; no history of metastatic disease; able to read English proficiently and to give informed written consent; recently diagnosed and not yet commenced adjuvant therapy.
Exclusion criteria
No exclusion criteria
Outcome results
None listed