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

Dana-Farber Cancer Institute

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Other: Survey

Study type: Interventional

Funder types: Other

Identifiers

NCT03070236

16-571

Details and patient eligibility

About

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))

Full 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.

Enrollment: 912 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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912 participants in 1 patient group

Patient-reported Outcomes Survey

Experimental group

Description:

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

Treatment:

Other: Survey