UKCTOCS Quality of Life Sub Study
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.
Over 200,000 women recruited at 13 collaborating centres throughout the United Kingdom were randomised into the three screening arms. 50,000 women were 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 were randomised to receive transvaginal ultrasonography while 100,000 women in the control arm received no screening.
All women were asked to complete psychosocial baseline questionnaires at randomisation. These included an examination of their knowledge, beliefs and attitudes to ovarian cancer screening. This information is only 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 completed 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 also completed questionnaires if they had surgery and again if the surgery revealed ovarian cancer. These women were then 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 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.
Mortality results and psychological outcomes were published at a public meeting in London on 17th December 2015 and also in the Lancet.
Publications arising from this research include:
L Fallowfield, I Solis-Trapala, U Menon, C Langridge, S May, I Jacobs, V Jenkins. The effect of ovarian cancer screening on sexual activity and functioning: results from the UK collaborative trial of ovarian cancer screening RCT British Journal of Cancer (2017) 116, 1111–1117, first published online 21 March 2017. Restricted access/subscription required.
Jacobs IJ, Menon U, Ryan A, Gentry-Maharaj A, Burnell M, Kalsi JK, Amso NN, ApostolidouS, Benjamin E, Cruickshank D, Crump DN, Davies SK, Dawnay A, Dobbs S, Fletcher G, Ford J, Godfrey K, Gunu R, Habib M, Hallett R, Herod J, Jenkins H, Karpinskyj C, Leeson S, Lewis SJ, Liston WR, Lopes A, Mould T, Murdoch J, Oram D, Rabideau DJ, Reynolds K, Scott I, Seif MW, Sharma A, Singh N, Taylor J, Warburton F, Widschwendter M, Williamson K, Woolas R, Fallowfield L, McGuire AJ, Campbell S, Parmar M, Skates SJ.Ovarian cancer screening and mortality in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial. The Lancet 387(10022): p945–956, 5 March 2016 . Open Access article first published online 17th December 2015 ahead of print.
Jenkins V, Fallowfield L, Langridge C, Barrett J, Ryan A, Jacobs I, Kilkerr J, Menon U, Farewell V. Psychosocial Factors Associated With Withdrawal From the United Kingdom Collaborative Trial of Ovarian Cancer Screening following 1 Episode of Repeat Screening. International Journal of Gynecological Cancer, 2015 (8):1519-25
Menon U, Kalsi R, Gentry-Haharaj A, Dawnay A, Habib M, Apostolidou S, Singh N, Benjamin E, Burnell M, Davies S, Sharma A, Gunu R, Godfrey K, Lopes A, Oram D, Herod J, Williamson K, Seif MW, Jenkins H, Mould T, Woolas R, Murdoch JB, Dobbs S, Amso NN, Leeson S, Cruickshank D, Scott I, Fallowfield L, Widschwendter M, Reynolds K, McGuire A, Campbell S, Parmar M, Skates SJ, Jacobs I. Risk Algorithm Using Serial Biomarker Measurements Doubles the Number of Screen-Detected Cancers Compared With a Single-Threshold Rule in the United Kingdom Collaborative Trial of Ovarian Cancer Screening. Journal of Clinical Oncology. 2015 May 11. pii: JCO.2014.59.4945. Article first published online 11 May 2015.
Barrett J, Jenkins V, Farewell , Menon U, Jacobs I, Kilkerr J, Ryan A, Langridge C, Fallowfield L for and on behalf of UKCTOCS trialists. Psychological morbidity associated with ovarian cancer screening: results from more than 23 000 women in the randomised trial of ovarian cancer screening (UKCTOCS). BJOG An International Journal of Obstetrics & Gynaecology. 2014, 121(9):1071–1079
Gentry-Maharaj A, Sharma A, Burnell M, Ryan A, Amso NN, Seif MW, Turner G, Brunell C, Fletcher G, Rangar R, Fallowfield LJ, Campbell S, Jacobs I, Menon U. Acceptance of transvaginal sonography by postmenopausal women participating in the United Kingdom Collaborative Trial of Ovarian Cancer Screening. Ultrasound Obstetrics and Gynecology 2012, 41(1):73-79.
Jacobs I, Gentry- Maharaj A, Burnell M, Manchanda R, Singh N, Sharma A, Ryan A, Seif MW, Amso NN, Turner G, Brunell C, Fletcher G, Rangar R, Ford K, Godfrey K, Lopes A, Oram D, Herod J, Williamson K, Scott I, Jenkins H, Mould T, Woolas R, Murdoch J, Dobbs S, Leeson S, Cuickshank D, Skates SJ, Fallowfield L, Parmar M, Campbell S, Menon U. Sensitivity of transvaginal ultrasound screening for endometrial cancer in postmenopausal women: a case-control study within the UKCTOCS cohort Lancet Oncology 2011;12:38-48.
Fallowfield LJ, Fleissig A, Barrett J, Menon U, Jacobs I, Kilkerr J and Farewell V. Awareness of ovarian cancer risk factors, beliefs and attitudes towards screening: baseline survey of 21,715 women participating in the UK Collaborative Trial of Ovarian Cancer Screening. British Journal of Cancer 103, 454-461
Menon U, Gentry-Maharaj A, Hallett R, Ryan A, Burnell M, Sharma A, Lewis S, Davies S, Philpott S, Lopes A Sensitivity and specificity of multimodal and ultrasound screening for ovarian cancer, and stage distribution of detected cancers: results of the prevalence screen of the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). Lancet Oncol 2009; 10: 327-40