Women with recently diagnosed early stage breast cancer are faced with multiple decisions that will impact their survival and quality of life. The availability of timely, relevant, and accurate health information for patients is crucial in this context. This study (Project 2) will develop and test two preparatory interventions for newly diagnosed early-stage breast cancer patients who call the Cancer Information Service of the NCI: 1) a state-of-the-science and highly interactive multimedia program that will be offered to patients in two platforms (CD-ROM, Internet), and 2) a callback intervention interview that will be conducted by CIS Information Specialists at 7 days follow-up. Both of these preparatory interventions will provide information, education and support for treatment decision-making as well as other emergent concerns and issues. Among newly diagnosed breast cancer patients who report access to a computer at baseline (during their usual service call to the CIS), a randomized three-group stepped design will be used, where: Group 1 = standard CIS service (+) standard CIS print material; Group 2 = Group 1 (+) the preparatory multimedia program; Group 3 = Group 2 (+) the CIS callback intervention interview. Eligible breast cancer patients who do not report access to a computer at baseline, will be given the opportunity to join a smaller randomized feasibility study, where: Group 1A = Group 1 above, and Group 2A = Group 1A (+) the CIS callback intervention interview. The main 3-arm study will have an enrolled sample at baseline of 360 per arm, for a combined sample of 1080, while the feasibility study will enroll 75 women per arm, for a total of 150. The overall research hypothesis for the main efficacy trial is that the primary study endpoints (including cancerspecific distress, decisional conflict, satisfaction with decision-making and knowledge) will show positive outcomes consistent with a dose-response gradient (i.e., Group 3 > Group 2 > Group 1). Additional analyses will also be conducted to test both mediator and moderator variables. Contingent on findings, one or both of these interventions will be offered for dissemination within the CIS, as well as in other similar service programs nationwide. In contrast, the 2-arm feasibility study will be conducted pursuant to a future efficacy trial to be conducted by the CISRC, where feasibility will be assessed in terms of eligibility, participation and cohort retention rates, as well as estimating effect sizes for the primary study endpoints listed above.
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