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

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Other: Survey

• Registration Number: NCT03070236
• Lead Sponsor: Dana-Farber Cancer Institute

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-02-16
• Study First Submitted QC: 2017-02-28
• Study First Posted: 2017-03-03
• Study Start: 2017-12-01
• Primary Completion: 2019-05-27
• Results First Submitted: 2020-01-10
• Results First Submitted QC: 2020-02-25
• Results First Posted: 2020-03-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2024-12-27
• Study Completion: 2030-02-25

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 912

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient-reported Outcomes Survey	Survey	The survey will administered online, over the phone, or via mail.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (6)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Newton-Wellesley Hospital; 🇺🇸 Newton, Massachusetts, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital; 🇺🇸 Weymouth, Massachusetts, United States