Breast Cancer
Conditions
Keywords
Breast Cancer
Brief summary
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))
Detailed description
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.
Interventions
OTHERSurvey
Select questions will be ask in the survey
Sponsors
Dana-Farber Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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: * Age 18 or more at index diagnosis * Diagnosed with DCIS, LCIS, ADH, or ALH between January 1, 2012 and June 30, 2017 * Able to read either English or Spanish and able to provide written (via paper), or on-line informed consent * Treated and followed at one of the study sites (including affiliated network sites) and for whom treatment and surveillance data are available, for at least 1 year of follow up after date of diagnosis * Participants with bilateral synchronous or metachronous disease (DCIS, LCIS, ADH, ALH) are eligible
Exclusion criteria
* Ever had a diagnosis of invasive or microinvasive breast cancer * DCIS prior to index lesion or history of progressive/recurrent DCIS after treatment * Other cancers (excluding non-melanoma skin cancer) diagnosed within 5 years prior to index lesion, including concurrent invasive cancer diagnosis and up to the present time of participant's approach to invitation into the study * Patients identified by treating physician as being unsuitable for contact
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Outcome Measures Severity of Chronic 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. | 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. |
Countries
United States
Contacts
STUDY_DIRECTORAnn H. Partridge, MD, MPH
Dana-Farber Cancer Institute
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 538 |
| Active Surveillance (AS) Women who receive a treatment strategy, under study for management of low-risk DCIS, that does not include surgery or radiation. | 374 |
| Total | 912 |
Baseline characteristics
| Characteristic | Guideline Concordant Care (GCC) | Total | Active Surveillance (AS) |
|---|---|---|---|
| Age, Continuous | 60.7 years | 59.8 years | 58.4 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 31 Participants | 50 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 503 Participants | 853 Participants | 350 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 9 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 22 Participants | 42 Participants | 20 Participants |
| Race (NIH/OMB) Black or African American | 40 Participants | 55 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 17 Participants | 26 Participants | 9 Participants |
| Race (NIH/OMB) White | 459 Participants | 789 Participants | 330 Participants |
| Region of Enrollment United States | 538 participants | 912 participants | 374 participants |
| Sex: Female, Male Female | 538 Participants | 912 Participants | 374 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 912 |
| other Total, other adverse events | 0 / 912 |
| serious Total, serious adverse events | 0 / 912 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Guideline Concordant Care (GCC) | The Primary Outcome Measures Severity of Chronic Pain. | 6.4 Composite Score |
| Active Surveillance (AS) | The Primary Outcome Measures Severity of Chronic Pain. | 3.0 Composite Score |