This study looks at the risks and benefits of active monitoring (AM) compared to surgery in the setting of a pragmatic prospective randomized trial for low risk DCIS. Our overarching hypothesis is that management of low-risk Ductal Carcinoma in Situ (DCIS) using an AM approach does not yield inferior cancer or quality of life outcomes compared to surgery.
Overdiagnosis and overtreatment resulting from mammographic screening have been estimated to be as high as 1 in 4 patients diagnosed with breast cancer although the absence of standard definitions for measuring overdiagnosis has led to much uncertainty around this estimate. The national health care expenditure resulting from false positive mammograms and breast cancer overdiagnosis has been estimated to approach $4 billion annually. There is general consensus that much of this burden derives from the treatment of DCIS; for those estimated 40,000 women per year whose DCIS may never have progressed even without treatment, medical intervention can only harm. In those women who undergo surgical management of DCIS, there is risk of developing persistent pain at the surgical site, with estimates ranging from 25-68%. Importantly, persistent pain after lumpectomy may be as prevalent as that after total mastectomy. Persistent postsurgical pain is rated by patients as the most troubling symptom, leading to disability and psychological distress, and is often resistant to management. Although prospective population-based data have demonstrated significant patient and surgical focus on pain with remarkably high levels of chronic pain 4 and 9 months after breast surgery, much of these data have been collected in women with invasive cancer, with little data directly relevant to patients with DCIS. The overarching hypothesis of the study is that management of low-risk DCIS using an active monitoring (AM) approach does not yield inferior cancer or quality of life outcomes compared to surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
997
Surgery +/- radiation choice for endocrine therapy
Choice for endocrine therapy
Proportion of New Diagnoses of Ipsilateral Invasive Cancer in Surgery and AM Arms at 2 Years of Follow up
To compare the number of patients that develop ipsilateral invasive cancer that received surgery to the number of patients that were placed on active monitoring after 2 years of follow-up
Time frame: At 2 years follow-up
Quality of Life (QOL)
Measured by Short Form (SF)-36
Time frame: Baseline, 6 months, 1 year, and once a year (years 2 through 5)
Psychological Outcomes
Measured by five dimensions questionnaire (EQ-5D)
Time frame: Baseline, 6 months, 1 year, and once a year (years 2 through 5)
Generalized Anxiety
Measured by the State Trait Anxiety Inventory (STAI) scale
Time frame: Baseline, 6 months, 1 year, and once a year (years 2 through 5)
Generalized Depression
Measured by the Center for Epidemiologic Studies Depression Scale (CES-D) 10
Time frame: Baseline, 6 months, 1 year, and once a year (years 2 through 5)
Coping
Coping evaluated using the Brief COPE, a shortened form of the COPE Inventory, inclusive of 28 items (14 subscales).
Time frame: Baseline
Intolerance of Uncertainty
Assessment of feelings of uncertainty using the Intolerance of Uncertainty Scale (Short-form), which has been used in studies of active monitoring in the prostate cancer setting.
Time frame: Baseline and at 2 years
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Providence Alaska Medical Center
Anchorage, Alaska, United States
Mayo Clinic
Phoenix, Arizona, United States
City of Hope
Duarte, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Sharp Memorial Hospital
San Diego, California, United States
Kaiser Permanente Medical Center
Vallejo, California, United States
Colorado Cancer Research Program
Denver, Colorado, United States
Saint Joseph Hospital- Cancer Centers of Colorado
Lafayette, Colorado, United States
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
...and 131 more locations
Mastectomy Rate
To compare the impact of surgery vs. AM on the number of mastectomies performed in patients with DCIS
Time frame: 2, 5, and 7 year follow-up
Breast Conservation Rate
To compare the impact of surgery vs. AM on the number of breast conservation surgeries performed in patients with DCIS
Time frame: 2, 5, and 7 year follow-up
Contralateral Invasive Cancer Rate
To compare the impact of surgery vs. AM on the rate of development of contralateral invasive cancer in patients with DCIS
Time frame: 2, 5, and 7 year follow-up
Overall Survival Rate
To compare the impact of surgery vs. AM on the overall survival rate in patients with DCIS
Time frame: 2, 5, and 7 year follow-up
Breast Cancer Specific Survival Rate
To compare the impact of surgery vs. AM on the breast cancer specific survival rate in patients with DCIS
Time frame: 2, 5, and 7 year follow-up
Ipsilateral Invasive Cancer Rate in Surgery Arm at 5 and 7 Year Follow-up
To determine the number of DCIS patients in the surgery arm that develop ipsilateral invasive cancer
Time frame: 5 and 7 year follow-up
Ipsilateral Invasive Cancer Rate in AM Arm
To determine the number of DCIS patients in the AM arm that develop ipsilateral invasive cancer
Time frame: 5 and 7 year follow-up