Quality of Life Study - Detailed Research Plan

Title: Improving outcomes for women with endometrial cancer: follow-up, survival, quality of life
CIs: PM Webb, AB Spurdle, A Obermair, M Janda, C Nagle, M Quinn, M Davy, M Oehler, A Brand, P Blomfield, Y Leung, L McQuire.

AIMS: to follow-up a cohort of ~1465 women diagnosed with endometrial cancer to document treatment and follow-up practices, patient outcomes (survival and quality of life) and determinants of these outcomes.

BACKGROUND: Endometrial cancer (cancer of the lining of the uterus) is the most common malignancy of the female genital tract. More than 1,600 women are diagnosed with endometrial cancer each year in Australia and this number is predicted to increase to almost 2,000 by the year 2011. Although most women are diagnosed with low grade tumours that have a good prognosis, about 20% have more aggressive tumours which are often associated with a poor outcome. This raises a number of important issues for public health. Although overall survival is good, many women will experience a recurrence and 15-20% will die from their disease within 5 years. Although there are strong clinical predictors of prognosis, it is not possible to reliably predict which women require more aggressive treatment or, conversely, those who will not benefit from additional treatment. Almost 20,000 women alive in Australia today have been treated for endometrial cancer but little is known about their ongoing health and quality of life (QoL). There is also considerable uncertainty regarding the optimal follow-up schedule for women after treatment for endometrial cancer. The proposed study will capitalise on the resource of the Australian National Endometrial Cancer Study (ANECS) to address these issues.

RESEARCH PLAN: ~1465 women with endometrial cancer diagnosed July 2005-Dec 2007 have participated in ANECS. At recruitment, women consented to allow access to their medical records and they were advised they might be re-contacted about future research. In the present study, Research Nurses will access women’s medical records and abstract information regarding their initial treatment, subsequent monitoring, any recurrences and management of these, and, if applicable, date and cause of death. Data will be collected a minimum of 3 years after diagnosis as the majority of recurrences occur within this time-frame. We will also invite women to take part in a ‘Quality of Life’ study and, if they consent, will mail a one-off questionnaire to collect information regarding their lifestyle post-diagnosis, on-going symptoms/health problems, QoL and psychosocial/psychosexual health. We will link the new clinical and QoL data to the extensive epidemiological (including full reproductive history, dietary information) and detailed pathology data collected in the parent study. We will (a) describe variation in treatment and monitoring across Australia and relate this to clinical and sociodemographic factors, (b) document 3-year recurrence-free and overall survival by tumour subtype, stage and grade and assess the value of additional parameters in predicting prognosis, (c) describe QoL, psychosexual health and supportive care needs of survivors and (d) document the impact of treatment, patient and lifestyle characteristics on recurrence-free and overall survival and quality of life.

OUTCOMES AND SIGNIFICANCE: The 2007 Senate report ‘Breaking the silence: a national voice for gynaecological cancers’ called for improved management of women with gynaecological cancer. For this to occur we need a clear understanding of the current patterns of care and outcomes for patients and to identify areas where changes could have the greatest positive effect. Our study will help fill this evidence gap. Specifically we will contribute information in a number of areas:

• Baseline information regarding current management and the impact of variation on outcomes;
• Better understanding of the role of vaginal vault cytology in monitoring recuurence;
• Identifying the health issues facing the 10,000+ endometrial cancer survivors in this country;
• Improved prediction of prognosis to allow more targeted treatment;
• Identification of potentially modifiable lifestyle factors associated with improved outcome.

Finally, addition of detailed clinical and outcomes data to the existing ANECS resource will allow future studies of cost-effectiveness, long-term survival and molecular predictors of outcome.