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Active, Not Recruiting

NCT Number: NCT03070236

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

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))

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survey

Other

Select questions will be ask in the survey

Primary outcomes

  1. The Primary Outcome Measures Severity of Chronic 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.

    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.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2030
First posted
Mar 3, 2017
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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