Rationale and study protocol for the Patient-Centered Outcome Aid (PCOA) randomized controlled trial: A personalized decision tool for newly diagnosed ovarian cancer patients

• Type of Material: Article
• Authors: L Wenzel, University of California Irvine; D Mukamel, University of California Irvine; K Osann, University of California Irvine; L Havrilesky, Duke University; L Sparks, Chapman University; Joseph Lipscomb, Emory University; AA Wright, Dana Farber Cancer Institute; J Walker, University of Oklahoma; R Alvarez, Vanderbilt University; L Van Le, University of North Carolina Chapel Hill; K Robison, Brown University; R Bristow, University of California Irvine; R Morgan, City Hope National Medical Center; BJ Rimel, Cedars Sinai; H Ladd, University of California Irvine; S Hsieh, University of California Irvine; A Wahi, University of California Irvine; D Cohn, Ohio State University
• Language: English
• Date: 2017-06-01
• Publisher: Elsevier: Creative Commons Attribution Non-Commercial No-Derivatives License
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2017 Elsevier Inc. All rights reserved.
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1016/j.cct.2017.03.006
• Title of Journal or Parent Work: Contemporary Clinical Trials Communications
• ISSN: 2451-8654
• Volume: 57
• Start Page: 29
• End Page: 36
• Grant/Funding Information: The content is solely the responsibility of the authors and does not necessarily represent the official views of PCORI or the National Institutes of Health.; Research reported in this publication was funded by a Patient-Centered Outcomes Research Institute (PCORI) award number CE-12-11-4755, and the National Cancer Institute of the National Institutes of Health under award number P30CA062203.
• Keywords: QUESTIONNAIRE; Research & Experimental Medicine; INFORMATION NEEDS; CARE; VALIDATION; Science & Technology; PACLITAXEL; PREFERENCES; SATISFACTION; VALIDITY; Medicine, Research & Experimental; Pharmacology & Pharmacy; Life Sciences & Biomedicine; GYNECOLOGIC-ONCOLOGY-GROUP; INTRAPERITONEAL CISPLATIN
• Research Categories: Health Sciences, Oncology

Abstract

Ovarian cancer carries the highest fatality to case ratio for all gynecologic malignancies. In 2016, it is estimated that 22,280 women will be diagnosed with ovarian cancer, and 14,240 will die of this life-threatening disease [1]. Due to the aggressive nature of the disease and the lack of effective screening, over 2/3 of women with ovarian cancer are diagnosed in stages III and IV (http://seer.cancer.gov), which is conventionally treated with a combination of aggressive surgical cytoreduction and cytotoxic chemotherapy. However, controversy over the most effective treatment for newly diagnosed stage III ovarian cancer persists, specifically evaluating whether a combination of intraperitoneal (IP) and intravenous (IV) chemotherapy is superior to IV alone [2–6]. Taken together, results from these clinical trials require clinicians and patients to carefully evaluate the risks and outcomes associated with IP or IV treatment, particularly since at this time there is no clear guidance on which treatment is better for a given patient. Adding to the complexity of this decision is the observation that ovarian cancer patients utilize progression free survival (PFS) time to drive the preference of type of chemotherapy, although they are willing to trade significant PFS time for reductions in treatment-related toxicity [7]. Very few studies have examined the use of decision aids within the setting of ovarian cancer, although several authors have explicitly argued that there is a need to practice shared decision-making in order to elicit preferences and incorporate this information into the ovarian cancer treatment discussion [8–10]. In fact, when assessing preferences, those ovarian cancer patients with more serious illness desired more shared decision-making; and in total, >80% of women wanted detailed information about their disease, treatment, and care [11]. Perceived involvement in decision-making about ovarian cancer treatment has been associated with better quality of life [12], although the approach for involving patients in decision making has been debated [13–17], particularly in life-threatening cancer diagnoses. A review of patient preferences for shared decisions, drawing inferences from 43 cancer studies analyses, concluded that 77% of the respondents wanted to participate in decisions, rather than delegating the treatment choice to the physician [18]. In fact, there has been a substantial increase in the percent of cancer patients who wish to participate in medical decision-making, reaching 85% over the last decade [18] The purpose of this study was to develop and test the effectiveness of a Patient-Centered Outcome Aid (PCOA) compared to a control condition of usual care, as patients chose between IV or IP therapy for advanced ovarian cancer. We developed an internet-based decision aid to improve patient-centered outcomes and tested it within a randomized clinical trial. The purpose of this paper is to describe the clinical trial development and protocol.