Clinical trial NCT03070236: PORTAL: Patient-reported Outcomes After Routine Treatment of Atypical Lesions
Official title: PORTAL: Patient-reported Outcomes After Routine Treatment of Atypical Lesions
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 912
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Primary Outcome Measures Severity of Chronic Pain.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Newton
country: United States
facility: Newton-Wellesley Hospital
state: Massachusetts
city: Weymouth
country: United States
facility: Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital
state: Massachusetts
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Ann H. Partridge, MD, MPH
role: STUDY_DIRECTOR
References: