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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

912 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2030-02-25

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))

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Patient-reported Outcomes Survey

The survey will administered online, over the phone, or via mail.

Group Type EXPERIMENTAL

Survey

Intervention Type OTHER

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Interventions

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Survey

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Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No