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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03070236
• Other study ID #: 16-571
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: February 25, 2030

Study information

• Verified date: February 2024
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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))

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 912
• Est. completion date: February 25, 2030
• Est. primary completion date: May 27, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Survey
Select questions will be ask in the survey

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Duke University Medical Center	Durham	North Carolina
United States	MD Anderson Cancer Center	Houston	Texas
United States	Newton-Wellesley Hospital	Newton	Massachusetts
United States	Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital	Weymouth	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Primary Outcome Measures Severity of Chronic Pain.	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.	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.