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    Research Grants Awarded

    Understanding Adjuvant Therapy and Clinical Trials: An Evaluation of an Online Synthetic Interview for Breast Cancer Patients

    Study Section:
    Psycho-Social and Complementary Treatment

    Scientific Abstract:
    Background: Accrual rates to adult oncology clinical trials are consistently reported to be very low. Cancer patients’ lack of awareness of trials or their fears and misconceptions about them contribute to poor accrual. Researchers evaluating the provision of clinical trial educational materials have reported mixed findings. However, p revious attempts at providing information to patients have utilized information that has been limited in scope, access, or format. Objective/Hypothesis: The purpose of this grant is to evaluate the effectiveness of an online interactive synthetic interview (SI) in delivering information about adjuvant therapy clinical trials to newly diagnosed breast cancer patients. We hypothesize that providing access to an SI will be more effective than traditional pamphlet-based information at increasing knowledge of and improving attitudes toward adjuvant therapy clinical trials. In addition, we hypothesize that patients using the SI will report less decisional conflict and greater decision satisfaction when faced with an actual decision regarding clinical trial enrollment. Specific Aims: (1) To develop understandable and useful SI content (in question and answer format) regarding adjuvant therapy for breast cancer patients; (2) To describe how newly diagnosed breast cancer patients utilize the adjuvant therapy and clinical trials SI; (3) To assess the impact of the SI on patients’ knowledge and attitudes regarding adjuvant therapy clinical trials; and (4) To evaluate the impact of the SI on clinical trial decisional conflict and decision satisfaction. Study Design: 100 breast cancer patients will be randomized to either receive pamphlets about adjuvant therapy and clinical trials or be given access to a clinical trial and adjuvant therapy SI in addition to the pamphlets. Knowledge and attitudes regarding adjuvant therapy clinical trials will be measured prior to enrollment, ten days after enrollment, and just prior to the initial consultation with a medical oncologist. Decisional conflict and decision satisfaction will be measured prior to the patient’s initial treatment. Potential Outcomes and Benefits of the Research: By evaluating this SI, we will gather information that will either support its dissemination or provide valuable ideas for future improvements. Ultimately, providing enhanced clinical trial information to patients should speed the process of delivering new treatments to all breast cancer patients.

    Lay Abstract:
    Background: New cancer treatments are required to be evaluated in research studies known as clinical trials. All trials need patients to participate before the results can be known and the successful treatments are made widely available. Cancer patients, however, are often not aware of clinical trials or may have fears about them. Previous attempts at providing clinical trial educational materials to patients have not always been very effective. However, the use of information that is comprehensive, multimedia, and accessible at all times has not yet been explored. Objective/Hypothesis: The purpose of this grant is to evaluate the effectiveness of an online interactive synthetic interview (SI) in delivering information about adjuvant therapy clinical trials to newly diagnosed breast cancer patients. We think that providing access to an SI will be more effective at increasing knowledge of and improving attitudes toward adjuvant therapy clinical trials than traditional pamphlet-based information delivery. In addition, we believe that patients using the SI will report less conflict and more satisfaction when faced with a decision regarding clinical trial enrollment. Specific Aims: (1) To develop understandable and useful SI content (in question and answer format) regarding adjuvant therapy for breast cancer patients; (2) To describe how newly diagnosed breast cancer patients utilize the adjuvant therapy and clinical trials SI; (3) To assess the impact of the SI on patients’ knowledge and attitudes regarding adjuvant therapy clinical trials; and (4) To evaluate the impact of the SI on patients’ conflict and satisfaction regarding their clinical trial decision. Study Design: 100 breast cancer patients will be assigned to one of two groups - a pamphlets only education group or a pamphlets plus SI group. Knowledge and attitudes regarding adjuvant therapy clinical trials will be measured prior to enrollment, ten days after enrollment, and just prior to the initial consultation with a medical oncologist. Decisional conflict and decision satisfaction will be measured prior to the patient’s initial treatment. Potential Outcomes and Benefits of the Research: By evaluating this SI, we will gather information that will either support its dissemination or provide valuable ideas for future improvements. Ultimately, providing enhanced clinical trial information to patients should speed the process of delivering new and better treatments to all breast cancer patients.