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

Study Overview
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Brief Summary
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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))

Detailed Description
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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.

Official Title
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PORTAL: Patient-reported Outcomes After Routine Treatment of Atypical Lesions

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Survey


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient-reported Outcomes Survey<br>The survey will administered online, over the phone, or via mail. | Other: Survey<br>* Select questions will be ask in the survey<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer