A 4-year study involving a 2 x 2 factorial randomized clinical trial
(RCT) is proposed to investigate quality of life (QOL) effects of: (1)
an intensive program of ovarian cancer screening including
transvaginal sonography (TVS) and annual CA125, staggered so that a
woman is screened by one or the other modality every 6 months, and
(2) group counseling specifically designed to reduce ovarian cancer-
releated anxiety through risk education and psychological support.
Hypotheses to be tested are driven by a self-regulation model or
health behavior developed by leventhal. About 320 women with a
family history of ovarian cancer and 160 average-risk women will be
recruited directly and through their physicians to participate in the
Screening for ovarian cancer is not currently recommended because
the disease is rare, screening efficacy has not been demonstrated,
and false positive test results may lead to surgery which carries its
own risks. However, guidelines consistently suggest that risk
assessment according to family history is needed and that women from
families with histories indicative of hereditary cancer syndrome should
undergo some form of regular screening. They offer no guidance
regarding how remaining patients' distress about their risk for
ovarian cancer should be addressesd. The study addresses the
relative efficacy of group risk education counseling and intensive
screening in reducing cancer-related worry and improving QOL.
Women at significant risk of carrying a dominant cancer susceptibility
gene will be identified so that the effects of individualized genetic
counseling on their QOL can be studied as will.
The evaluation plan includes an exploratory piece to estimate the
"shape" of the QOL line over the intervention period, as well as
methods to assess the change in QOL over the period. QOL is
measured by the RAND-36, which incorporates physical, social, and
psychological functioning, and the level of distress attributable to
ovarian cancer worry and ovarian-cancer-related events. Distress will
be measured on random days throughout the intervention period as
well as at baseline and follow-up. A cost-effectiveness component is
included in the evaluation plan.
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