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

NCT03070236 | Active Not Recruiting Results DMC

• 1 other identifier: 16-571
• Study Type: interventional
• Target: 912
• Locations: 1 country
• Sites: 6

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))

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Patient-reported Outcomes Survey

EXPERIMENTAL

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

Other: Survey

Interventions

Survey OTHER

Select questions will be ask in the survey

Patient-reported Outcomes Survey

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (6)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Newton-Wellesley Hospital

Newton, Massachusetts, 02462, United States

Location

Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital

Weymouth, Massachusetts, 02198, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Ann H. Partridge, MD, MPH
• Organization: Dana-Farber Cancer Institute (DFCI)

Ann_Partridge@dfci.harvard.edu

617-632-3800

Study Officials

• Ann H. Partridge, MD, MPH

  Dana-Farber Cancer Institute

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Adult Survivorship Program

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: March 3, 2017
• Study Start: December 1, 2017
• Primary Completion: May 27, 2019
• Study Completion (Estimated): February 25, 2030
• Last Updated: February 3, 2026
• Results First Posted: March 9, 2020

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)