UKCTOCS home page Trial design UK COLLABORATIVE TRIAL OF OVARIAN CANCER SCREENING Funding organisations Collaborative centres
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Objectives



Subjects

Size of study population

 

Source of recruitment
 



Inclusion criteria
 



Exclusion criteria
 



Overall Trial Design
 

Flow diagram - Trial design



Screening Tests

  1. Ultrasonography

    Ovarian morphology will be assessed for the presence of cysts, cyst volume and characteristics and solid areas.
    Morphology will be classified as


    Flow diagram - Management of ultrasound arm

     
  2. CA125
       
    Flow diagram - Calculation of Risk of Ovarian Cancer




UKCTOCS PSYCHOSOCIAL ARM

UKCTOCS Psychosocial Study is a 10 year project looking at the emotional, social and sexual effects of screening to detect ovarian cancer at an early stage in women aged 50 to 74 in the general population who have passed the menopause. We hope that screening for ovarian cancer will prove helpful but it is important to see if these benefits have costs to women, in particular if some types of screening are more acceptable than others.

200000 women will be asked to join the study at 13 hospitals throughout the United Kingdom. 50000 women will be offered multimodal screening which involves a blood test and ultrasound, 50000 women will be offered transvaginal ultrasonography while 100000 women in the control arm will not receive screening. The type of screening offered or being in the control group will be down to chance � a process known as randomisation - which is the only scientific way to study whether or not screening is worthwhile.

All women will be asked to fill in questionnaires at randomisation. These will ask questions about emotional well being, psychological functioning, sexual activity and what they know, believe and think about ovarian cancer screening. Some women will be randomly chosen for more regular questionnaires (250 women in each screening arm and 500 in the control arm) or if any woman's screening results are not straightforward. They will fill in a set of postal questionnaires every year for 6 years. These also look at their emotional well being, psychological functioning, sexual activity and the acceptability of the screening process after each screen. Different questionnaires will be given if they have surgery and again if the surgery reveals that they have ovarian cancer. These women will then sent a questionnaire at 6 months after surgery.

The main points of the psychosocial study are:

To assess the behavioural, psychosocial and psychosexual responses of women to ovarian cancer screening

Volunteers Numbers of women in the study

Who can join
 
  • Age 50-74 years
  • Postmenopausal
Who cannot join the study
 
  • Anyone who has had both ovaries removed (Bilateral oophorectomy)
  • Anyone who already has cancer
  • Women who have had an ovarian cancer in the past
  • Women at high risk of ovarian cancer due to their family history
  • Woman participating in other ovarian cancer screening trials

Psychosocial Questionnaires
 
  • General Health Questionnaire � 12 item
  • Spielberger State/Trait Anxiety Inventory
  • Sexual Activity Questionnaire
  • Attitude, Knowledge and Perception of Risk Questionnaire
  • Acceptability of Screening Questionnaire
  • Functional Assessment of Cancer Therapy � Ovarian


 

Psychosocial arm study design


 

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Last updated 31.10.03