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This research study is evaluating how patients feel physically and emotionally after a prior breast biopsy for specific breast conditions (including atypical lesions such as atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH), lobular carcinoma in situ (LCIS), and/or ductal carcinoma in situ (DCIS))
The goal of this research is to better understand the experience of women who have been diagnosed with certain breast conditions to enable women (and their doctors) to make informed decisions about their care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient-reported Outcomes Survey | Experimental | The survey will administered online, over the phone, or via mail. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survey | Other | Select questions will be ask in the survey |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Outcome Measures Severity of Chronic Pain. | The Breast Cancer Pain Questionnaire (BCPQ) is a validated, self-reported instrument assessing pain severity, pain frequency (how many days per week), and pain location (breast, arm, side, axilla) over the last 2-week period with an average of 45.8 months from treatment for the two groups, Guideline Concordant Care (GCC) and Active Surveillance (AS). The Pain Burden Index (PBI) is a composite of pain severity, pain frequency, and pain location. Each severity answer is multiplied by each frequency answer and then summed with a total possible score ranging from 0-200 with higher scores indicating worse pain. | Patient reported outcome was scheduled from at least one year from diagnosis. Participants' time from diagnosis to completing a survey was an average of 45.8 months in this study cohort. |
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Inclusion Criteria:
Patients treated at DUMC, DFCI, MDACC, MGH, NWH, or DFCI @ SSH with a diagnosis of DCIS, LCIS, ADH, or ALH who are also:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann H. Partridge, MD, MPH | Dana-Farber Cancer Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Dana-Farber Cancer Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | Guideline Concordant Care (GCC) & Active Surveillance (AS) | Guideline Concordant Care (GCC): Women who receive a combination of surgery, radiation and hormonal therapy - treatments similar to those recommended to patients with invasive cancer. Active Surveillance (AS): Women who receive a treatment strategy, under study for management of low-risk DCIS, that does not include surgery or radiation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Guideline Concordant Care (GCC) | Women who receive a combination of surgery, radiation and hormonal therapy - treatments similar to those recommended to patients with invasive cancer. |
| BG001 | Active Surveillance (AS) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Outcome Measures Severity of Chronic Pain. | The Breast Cancer Pain Questionnaire (BCPQ) is a validated, self-reported instrument assessing pain severity, pain frequency (how many days per week), and pain location (breast, arm, side, axilla) over the last 2-week period with an average of 45.8 months from treatment for the two groups, Guideline Concordant Care (GCC) and Active Surveillance (AS). The Pain Burden Index (PBI) is a composite of pain severity, pain frequency, and pain location. Each severity answer is multiplied by each frequency answer and then summed with a total possible score ranging from 0-200 with higher scores indicating worse pain. | Posted | Mean | Full Range | Composite Score | Patient reported outcome was scheduled from at least one year from diagnosis. Participants' time from diagnosis to completing a survey was an average of 45.8 months in this study cohort. |
|
Approximately 19 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Guideline Concordant Care (GCC) & Active Surveillance (AS) | Guideline Concordant Care (GCC): Women who receive a combination of surgery, radiation and hormonal therapy - treatments similar to those recommended to patients with invasive cancer. Active Surveillance (AS): Women who receive a treatment strategy, under study for management of low-risk DCIS, that does not include surgery or radiation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ann H. Partridge, MD, MPH | Dana-Farber Cancer Institute (DFCI) | 617-632-3800 | Ann_Partridge@dfci.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 20, 2019 | Jan 10, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 20, 2019 | Jan 10, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Boston |
| Massachusetts |
| 02215 |
| United States |
| Newton-Wellesley Hospital | Newton | Massachusetts | 02462 | United States |
| Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital | Weymouth | Massachusetts | 02198 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
Women who receive a treatment strategy, under study for management of low-risk DCIS, that does not include surgery or radiation.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Women who receive a combination of surgery, radiation and hormonal therapy - treatments similar to those recommended to patients with invasive cancer.
| OG001 | Active Surveillance (AS) | Women who receive a treatment strategy, under study for management of low-risk DCIS, that does not include surgery or radiation. |
|
|
| 0 |
| 912 |
| 0 |
| 912 |
| 0 |
| 912 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |