Project Summary  

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Each year in the United States, about 300,000 women receive a diagnosis of breast cancer. In about 60,000 of these women, a mammogram shows abnormal cells inside the milk ducts in the breast. This condition is called ductal carcinoma in situ, or DCIS. Only about 20 percent of DCIS cases turn into invasive cancer, which is cancer that spreads and causes illness. Many women can live with DCIS without it ever harming them. However, doctors usually treat DCIS the same way they treat invasive cancers, using surgery or radiation, which can cause pain and worry.

Many doctors and researchers believe that instead of having surgery or radiation right away, women with DCIS can choose to watch for changes in their condition through regular checkups, called watchful waiting. Currently, only 3 percent of women with DCIS choose watchful waiting. This study compares the benefits and harms of watchful waiting to standard treatment for women with DCIS.

Who can this research help?

Results of this study may help doctors and patients decide how to treat DCIS.

What is the research team doing?

The research team is looking at information from two national cancer databases and a patient survey. The team wants to know how often DCIS becomes invasive cancer in women who choose watchful waiting compared with women who choose standard treatment. The team is also comparing women’s quality of life, pain, anxiety, fear of cancer spreading, and body image between the two groups.

Patients, including cancer survivors, are helping to design the study, select research questions, and suggest ways to recruit study participants.

Research methods at a glance

Design Elements	Description
Design	Observational: retrospective cohort study and cross-sectional survey
Population	Data from 2 complementary data sets, the Surveillance, Epidemiology, and End Results (SEER)-Medicare database and the National Cancer Database, about women who received a DCIS diagnosis between 1991 and 2011 and who received active surveillance or breast cancer guideline-concordant care
Interventions/ Comparators	Active surveillance (watchful waiting) Standard treatment (e.g., surgery, radiation)
Outcomes	Primary: new or advanced cancer diagnosis, chronic pain Secondary: breast cancer mortality, all-cause mortality, diagnosis of new health conditions, receipt of radiation, receipt of chemotherapy, quality of life, anxiety, fear of recurrence, body image, decision quality
Timeframe	Up to 10-year retrospective follow up for primary outcomes

Project Details

Principal Investigator

Shelley Hwang, MD, MPH

Project Status

In PCORI Peer-Review Process

Project Title

PORTAL: Patient-reported Outcomes after Routine Treatment of Atypical Lesions

Board Approval Date

September 2015

Project End Date

January 2021

Organization

Duke University

Year Awarded

2015

State

North Carolina

Project Type

Research Project

Health Conditions  

Cancer

Breast Cancer

Intervention Strategies

Drug Interventions
Other Clinical Interventions

Populations

Low Income
Women

Funding Announcement

Assessment of Prevention, Diagnosis, and Treatment Options

Project Budget

$1,772,381

Study Registration Information

HSRP20162122

NCT03070236