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 RCT. 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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