Principal Investigator: Professor Dame Lesley Fallowfield

Co-investigator: Professor Ian Jacobs, Gynaecological Cancer Research Centre, Institute of Women's Health, University College London

Funded by: Medical Research Council (2000-2011)

UKCTOCS is an 11 year project investigating the behavioural, psychosocial and psychosexual implications of ovarian cancer screening to postmenopausal women aged 50 to 74 in the general population. Despite the putative benefits, there are potential disadvantages to screening for ovarian cancer which include the psychosocial costs of unnecessary surgery and other sequelae resulting from the different methods employed in the screening process itself.

200,000 women will be recruited at 13 collaborating centres throughout the United Kingdom and randomised into the three screening arms. 50,000 women will be randomised to receive multimodal screening involving serum assay of the tumour marker CA125. (This has been shown to be the best overall tumour marker for epithelial ovarian cancer). 50,000 women will be randomised to receive transvaginal ultrasonography while 100,000 women in the control arm will not receive screening.

All women will complete psychosocial baseline questionnaires at randomisation. These will include an examination of their knowledge, beliefs and attitudes to ovarian cancer screening. This information will only be entered into the study database if the women are subsequently randomly chosen for longitudinal follow-up (250 women in each screening arm and 500 in the control arm) or if any woman's screening results are not straightforward.

Volunteers will complete a set of postal questionnaires annually for 6 years to assess their emotional well-being, psychological functioning, sexual activity and the acceptability of the screening process after each screen. Women will also complete questionnaires if they undergo surgery and again if the surgery reveals that they have ovarian cancer. These women will then be followed longitudinally at 6 months post surgery.

The main study has closed and the psychosocial study has enrolled 185,693 women. It is the largest database of psychological and sexual information collected and next year we aim to collaborate with Professor Peter Selby's psychosocial oncology group on an item banking protocol. The UKCTOCS data from standardised questionnaires including the General Health Questionnaire 12 (GHQ12) and Speilberger Trait Anxiety Inventory (STAI) are a valuable resource for researchers working on item banking and computer adaptive testing.

^ Top