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Institute Director

Peter Brocklehurst

Professor
Peter Brocklehurst




Director of the Institute for Women’s Health at UCL and Co-Director of the Department of Health Policy Research Unit in Maternal Health and Care, University of Oxford. I spent 100% of my time on academic activities.
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Psychosocial Study Information Sheet

Design

Randomised controlled trial with three arms:

  1. Control group (no screening)
  2. Multimodal group (annual screening with serum CA 125 as primary test and CA125 and ultrasound as secondary test)
  3. Ultrasound group (annual screening with ultrasound as primary test and repeat ultrasound as secondary test)
Objectives/aims:

Overall Aim

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

Study Aims

  • To examine the knowledge, beliefs and attitudes of women in a general population sample to ovarian cancer screening
  • To investigate the effect of different screening procedures on women's anxiety, depression and sexual functioning
  • To examine women's perception of ovarian cancer risk and the impact that this has on willingness to attend for screening and subsequent compliance
  • To compare women's satisfaction with, and acceptability of, the different screening procedures
Endpoints/primary outcomes:
  • Changes in behavioural, psychosocial and psychosexual responses of women to ovarian cancer screening � these will be analysed as differences in means, proportions, normal deviates and correlations as appropriate
  • Identification of baseline characteristics that predict which women are most likely to develop psychological and sexual problems, which may require further intervention and support.
  • Evaluation of women's satisfaction with, and acceptability of, the different screening procedures
  • Information of women's knowledge, beliefs and attitudes to ovarian cancer screening and the effect that beliefs and attitudes have on those who accept the offer of screening and their subsequent adherence to the screening process
  • Identification of the perceptions of risk of women who present for screening and how these perceptions impact on their adherence and screening behaviours over time
  • Information about women's educational needs regarding ovarian screening
Inclusion/Exclusion criteria: As for main clinical trial
Planned sample size: Baseline questionnaires on 200,000 postmenopausal women, 100,000 randomised to the control arm, 50,000 randomised to multimodal screening, 50,000 randomised to ultrasound screening.

Random sample of 250 women followed up for 6 years in each screening arm and 500 women in the control arm
Baseline measures and follow up:

At baseline all women will complete:

  1. General Health Questionnaire � 12 item
  2. Spielberger State/Trait Anxiety Inventory
  3. Sexual Activity Questionnaire
  4. Attitude, Knowledge and Perception of Risk Questionnaire

Women in random sample and all women with abnormal screens will complete these questionnaires after hospital visits:

  1. General Health Questionnaire � 12 item
  2. Spielberger State/Trait Anxiety Inventory
  3. Sexual Activity Questionnaire
  4. Acceptability of Screening Questionnaire (not controls)

Women who have surgery will complete the following questionnaires:

  1. General Health Questionnaire � 12 item
  2. Spielberger State/Trait Anxiety Inventory
  3. Sexual Activity Questionnaire

Those found to have ovarian cancer will complete the following:

  1. Functional Assessment of Cancer Therapy � Ovarian
Trial duration: January 2001 - December 2010

Page last modified on 17 jul 09 16:05 by Vijay Devineni