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Comparing the effectiveness of guideline-concordant care to active surveillance for ductal carcinoma in situ (DCIS): an observational study
Investigator (PI): Hwang, Shelley
Performing Organization (PO): (Current): Duke University, School of Medicine, Department of Surgery, Division of Surgical Oncology / (919) 681-3442
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2016
Final Year: 2020
Record Source/Award ID: PCORI/CER-1503-29572
Funding: Total Award Amount: $1,720,376
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: The term "overdiagnosis" is typically present with the conditions that look like early cancer but are not destined to cause symptoms or death. It has been estimated that overtreatment may be experienced by as many as 1 in 4 patients with breast cancer that was detected by breast cancer screening. There is general consensus that much of this burden derives from the treatment of ductal carcinoma in situ (DCIS), or preinvasive breast cancer. Currently, almost all DCIS is treated aggressively, according to guideline-concordant care (GCC). Of those treated, those who would not have developed cancer without it might not have received a benefit. An alternative to GCC is active surveillance (AS). Currently, only 3 percent of women in the United States with DCIS opt for AS; however, in order to consider AS as a future treatment option for DCIS, it is imperative that long-term health and quality-of-life outcomes resulting from AS are critically evaluated. Outcomes: The overarching goal for this study is to evaluate the benefits and harms of GCC compared with AS for DCIS, based on retrospective population-based outcome data as well as cross-sectional patient survey data. The primary outcomes will be diagnosis of cancer and severity of chronic pain. In addition, the study will also provide rigorous comparative evidence regarding other outcomes of importance to patients, including need for such treatments as radiation and chemotherapy, quality of life, anxiety, fear of recurrence, and body image, associated with AS compared with GCC. Importance to patients: DCIS is almost entirely diagnosed among women undergoing mammographic screening, and this patient population will be most impacted by the findings of the study. Strategies to reduce overtreatment will improve the benefit/harm ratio of screening for invasive breast cancer. Thus, this research will ultimately affect all women who are candidates for breast cancer screening. The deliverables from this project will provide clear, objective, evidence-based information, regarding the benefits and harms of DCIS treatment, to patients, health care providers, and other stakeholders. Moreover, this project will create a path forward for mitigating the potential overtreatment of screen-detected conditions. Patient engagement: The study design has incorporated enormous input from patient advocates. From the perspective of cancer survivors, one of whom is currently undergoing AS for DCIS, patient advocates have participated in all phases of grant planning and study design. The advocate investigators' role in the project will include all of the following: 1) to collaborate with investigators in the design of the study, 2) to propose strategies for effective patient recruitment and outreach, 3) to develop mechanisms to improve the study's reach into vulnerable and underrepresented socioeconomic groups, 4) to select priority research questions, and 5) to develop mechanisms to enhance the dissemination and translation of findings.
MeSH Terms:
  • Breast Neoplasms /*diagnosis
  • /*epidemiology /therapy
  • Carcinoma, Intraductal, Noninfiltrating /*diagnosis
  • /*epidemiology /therapy
  • Comparative Effectiveness Research
  • Cross-Sectional Studies
  • Evidence-Based Medicine
  • Female
  • Guidelines as Topic
  • Humans
  • Mammography /methods
  • Mass Screening /methods
  • Observational Studies as Topic
  • Outcome Assessment (Health Care)
  • Program Development
  • Quality of Life
  • Research Design
  • Retrospective Studies
  • Social Class
  • Survivors
  • United States
Country: United States
State: North Carolina
Zip Code: 27710
UI: 20162122
Project Status: Ongoing