Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial For Low Risk DCIS (COMET)
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|ClinicalTrials.gov Identifier: NCT02926911|
Recruitment Status : Recruiting
First Posted : October 6, 2016
Last Update Posted : February 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|DCIS Ductal Carcinoma in Situ||Other: Guideline Concordant Care Other: Active Surveillance||Not Applicable|
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 surveillance (AS) approach does not yield inferior cancer or quality of life outcomes compared to guideline concordant care (GCC).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial For Low Risk DCIS: A Phase III Prospective Randomized Trial|
|Actual Study Start Date :||February 22, 2017|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||July 2023|
Active Comparator: Guideline Concordant Care
DCIS - Surgery +/- radiation choice for endocrine therapy (MMG q 12 months x 5 years usual care for recurrent disease)
Other: Guideline Concordant Care
Surgery +/- radiation choice for endocrine therapy
Experimental: Active Surveillance
DCIS - Choice for endocrine therapy (MMG q 6 months x 5 years GCC for invasive progression)
Other: Active Surveillance
Choice for endocrine therapy
- Proportion of new diagnoses of ipsilateral invasive cancer in GCC and AS arms at 2 years of follow up [ Time Frame: At 2 years follow-up ]To compare the number of patients that develop ipsilateral invasive cancer that received guidance concordant care to the number of patients that were placed on active surveillance after 2 years of follow-up
- Quality of Life (QOL) [ Time Frame: Baseline, 6 months, 1 year, and once a year (years 2 through 5) ]Measured by Short Form (SF)-36
- Psychological outcomes [ Time Frame: Baseline, 6 months, 1 year, and once a year (years 2 through 5) ]Measured by five dimensions questionnaire (EQ-5D)
- Generalized anxiety [ Time Frame: Baseline, 6 months, 1 year, and once a year (years 2 through 5) ]Measured by the State Trait Anxiety Inventory (STAI) scale
- Generalized Depression [ Time Frame: Baseline, 6 months, 1 year, and once a year (years 2 through 5) ]Measured by the Center for Epidemiologic Studies Depression Scale (CES-D) 10
- Coping [ Time Frame: Baseline ]Coping evaluated using the Brief COPE, a shortened form of the COPE Inventory, inclusive of 28 items (14 subscales).
- Intolerance of uncertainty [ Time Frame: Baseline and at 2 years ]Assessment of feelings of uncertainty using the Intolerance of Uncertainty Scale (Short-form), which has been used in studies of active surveillance in the prostate cancer setting.
- Mastectomy rate [ Time Frame: 2, 5, and 7 year follow-up ]To compare the impact of GCC vs. AS on the number of mastectomies performed in patients with DCIS
- Breast conservation rate [ Time Frame: 2, 5, and 7 year follow-up ]To compare the impact of GCC vs. AS on the number of breast conservation surgeries performed in patients with DCIS
- Contralateral invasive cancer rate [ Time Frame: 2, 5, and 7 year follow-up ]To compare the impact of GCC vs. AS on the rate of development of contralateral invasive cancer in patients with DCIS
- Overall survival rate [ Time Frame: 2, 5, and 7 year follow-up ]To compare the impact of GCC vs. AS on the overall survival rate in patients with DCIS
- Breast cancer specific survival rate [ Time Frame: 2, 5, and 7 year follow-up ]To compare the impact of GCC vs. AS on the breast cancer specific survival rate in patients with DCIS
- Ipsilateral invasive cancer rate in GCC arm at 5 and 7 year follow-up [ Time Frame: 5 and 7 year follow-up ]To determine the number of DCIS patients in the GCC arm that develop ipsilateral invasive cancer
- Ipsilateral invasive cancer rate in AS arm [ Time Frame: 5 and 7 year follow-up ]To determine the number of DCIS patients in the AS arm that develop ipsilateral invasive cancer
- Breast MRI utilization rate [ Time Frame: 2, 5, and 7 year follow-up ]Determine the rate of use of breast MRI imaging compared to use of other breast imaging techniques
- Breast biopsy rate [ Time Frame: 2, 5, and 7 year follow-up ]Determine the rate of biopsies performed during follow-up of patients with DCIS
- Radiation rate [ Time Frame: 2, 5, and 7 year follow-up ]Determine the rate of the performance of radiation therapy on patients with DCIS
- Chemotherapy rate [ Time Frame: 2, 5, and 7 year follow-up ]Determine the rate of the use of chemotherapy on patients with DCIS
- Self-reported co-morbidity [ Time Frame: 6 months, 1 year, and once a year (years 2 through 5) ]Self-reported diary
- Adherence to hormonal therapy [ Time Frame: 6 months, 1 year, and once a year (years 2 through 5) ]Evaluated with a drug diary
- Symptoms [ Time Frame: Baseline, 6 months, 1 year, and once a year (years 2 through 5) ]A modified 19-item version of the Breast Cancer Prevention Trial (BCPT) Symptom Checklist will evaluate commonly reported menopausal symptoms
- General pain [ Time Frame: Baseline, 6 months, 1 year, and once a year (years 2 through 5) ]Evaluated with the Brief Pain Inventory, a well-validated general measure of pain and disability worst pain, least pain, and interference
- Breast specific pain [ Time Frame: Baseline, 6 months, 1 year, and once a year (years 2 through 5) ]Breast specific pain will be measured by the Breast Cancer Pain Questionnaire (BCPQ); the BCPQ includes assessment of pain severity, pain frequency (how many days/week), and pain location (breast, arm, side, axilla), from which a Pain Burden Index (PBI) can be calculated
- Body image [ Time Frame: Baseline, 6 months, 1 year, and once a year (years 2 through 5) ]Body image will be evaluated by the Breast-Questionnaire, a validated instrument to evaluate outcomes following surgery, will be used to evaluate satisfaction with body image
- Decisional regret [ Time Frame: Years 1 through 5 ]The Decision Regret Scale will measure how women perceived their DCIS treatment decision. The SURE scale, which is composed of four items from the Decisional Conflict Scale will be used to measure patients' uncertainty about which treatment to choose and factors contributing to uncertainty (feeling uninformed, unclear values, and unsupported in decision-making).
- Knowledge [ Time Frame: Baseline and 2 years ]DCIS and breast cancer knowledge will be measured with items adapted from the Breast Cancer Surgery Decision Quality Instrument (BCS-DQI) as well as questions developed specifically for a study that assessed DCIS knowledge and risk perceptions. The investigators will assess risk perceptions in women with DCIS using questions developed by Lerman and Croyle that will measure risk perceptions in relation to psychosocial outcomes in women with DCIS
- Risk perceptions [ Time Frame: Baseline and 2 years ]Measured by the Breast Cancer Surgery Decision Quality Instrument (BCS-DQI)
- Communication with physicians [ Time Frame: Baseline ]To assess communication with physicians about DCIS management options, the investigators will adapt items used in a prior study of surgical decision-making, including the extent to which their physician talked to them about AS vs. GCC. Additionally the investigators will ask about sources of information for the management of their DCIS
- Financial burden [ Time Frame: 6 months ]The investigators will adapt items from the National Health Interview Survey and the Cancer Outcomes Research and Surveillance (CanCORS) Study to assess financial burden. The investigators will also ask women to Cancer Care estimate out of pocket expenses attributed to their DCIS diagnosis.
- Employment status [ Time Frame: Baseline, 6 months, year 1, and once a year (years 1 through 5) ]Employment status will be assessed using a measure that is being added to the Alliance Patient Questionnaire as it has been tested and validated in breast cancer populations.
- Concerns about future breast events [ Time Frame: Baseline and 2 years ]Four items from the Quality of Life in Adult Cancer Survivors (QLACS) scale will be adapted to evaluate frequency (1=never; 7=always) of worries about DCIS, including concerns about future breast events and death from DCIS
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02926911
|Contact: Thomas Lynch, PhD||(443) firstname.lastname@example.org|
|Contact: Shelley Hwang, MD, MPH||(919) email@example.com|
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|Principal Investigator:||Shelley Hwang, MD, MPH||Duke University|
|Study Chair:||Ann Partridge, MD, MPH||Dana-Farber Cancer Institute|
|Study Chair:||Alastair Thompson, MD||Baylor College of Medicine|