Over 22,000 women will be diagnosed with ovarian cancer in 2008. Most will be diagnosed in advanced stages, and will experience a recurrence within 2 years after treatment. Aggressive chemotherapy and disease progression cause a wide range of symptoms that can significantly impair quality of life (QOL). An innovative intervention, WRITE Symptoms(c) [Written Representational Intervention To Ease Symptoms], builds on previous approaches to symptom management through an emphasis on understanding a patient's representation of her most significant symptom cluster prior to providing new information. Currently, WRITE Symptoms(c) is delivered by nurses via Internet message boards. A current pilot study of women with recurrent ovarian cancer has shown that WRITE Symptoms(c) is a feasible, acceptable intervention, and preliminary analyses provide early support for efficacy of the intervention. A key question is whether individualization by nurses is critical to the success of the WRITE Symptoms(c) Intervention, or whether women can be guided through the program by a web-based, interactive computer module without assistance from a nurse (referred to as """"""""Self-directed WRITE Symptoms(c)""""""""). Development of the self- directed module is complete and preliminary evaluations support its feasibility;acceptability;and content, functional, and theoretical validity. The primary aim of the proposed study is to compare the efficacy of nurse-guided WRITE Symptoms(c) vs. self-directed WRITE Symptoms(c) vs. care as usual in improving representations (severity, consequences, distress, and controllability) of target symptoms for women with recurrent ovarian cancer. Secondary aims are to 1) compare the relative efficacy of each intervention for improving QOL, communication with health care providers, and use of symptom management strategies;2) explore potential long-term effects of the 3) evaluate whether changes in symptom representations mediate changes in QOL;and 4) evaluate moderators of intervention effect. To address study aims, 480 women with recurrent ovarian cancer who are experiencing 3 or more disease- or treatment-related symptoms will be recruited from Gynecologic Oncology Group clinics across the country. Subjects will complete baseline measures of demographic and clinical information, symptom representations, and QOL. Following baseline assessment, women will be randomly assigned to one of three interventions: nurse-guided WRITE Symptoms(c), self- directed WRITE Symptoms(c), or Care-as-usual. Subjects in the two WRITE Symptoms arms engage in the interventions over the first 7 weeks of the study. Outcome measures are assessed monthly. This study evaluates an innovative approach to symptom assessment and management. The knowledge to be gained about critical components of psycho-educational interventions and mechanisms through which they effect changes in outcomes could improve symptom management across patient populations. interventions;
Each year over 22,000 women are diagnosed with ovarian cancer and over 14,000 die of the disease. Research to improve the quality of life for ovarian cancer patients was identified as a priority at the 2000 CDC sponsored workshop entitled """"""""Identifying Public Health Opportunities to Reduce the Burden of Ovarian Cancer"""""""". Information gained from the proposed study testing the efficacy of two web-based approaches to ovarian cancer symptom management should advance understanding of the critical elements of interventions needed to reduce cancer-related morbidity in improve quality of life.
