Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03070236
Recruitment Status : Active, not recruiting
First Posted : March 3, 2017
Results First Posted : March 9, 2020
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
Ann H. Partridge, MD, MPH, 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))

Condition or disease Intervention/treatment Phase
Breast Cancer Other: Survey Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 912 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: PORTAL: Patient-reported Outcomes After Routine Treatment of Atypical Lesions
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : May 27, 2019
Estimated Study Completion Date : February 25, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patient-reported Outcomes Survey
The survey will administered online, over the phone, or via mail.
Other: Survey
Select questions will be ask in the survey




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070236


Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Newton-Wellesley Hospital
Newton, Massachusetts, United States, 02462
Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital
Weymouth, Massachusetts, United States, 02198
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Layout table for investigator information
Study Director: Ann H. Partridge, MD, MPH Dana-Farber Cancer Institute
  Study Documents (Full-Text)

Documents provided by Ann H. Partridge, MD, MPH, Dana-Farber Cancer Institute:
Study Protocol  [PDF] May 20, 2019
Statistical Analysis Plan  [PDF] May 20, 2019

Layout table for additonal information
Responsible Party: Ann H. Partridge, MD, MPH, Director, Adult Survivorship Program, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03070236    
Other Study ID Numbers: 16-571
First Posted: March 3, 2017    Key Record Dates
Results First Posted: March 9, 2020
Last Update Posted: July 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ann H. Partridge, MD, MPH, Dana-Farber Cancer Institute:
Breast Cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases