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

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ClinicalTrials.gov Identifier: NCT03070236
Recruitment Status : Enrolling by invitation
First Posted : March 3, 2017
Last Update Posted : February 12, 2018
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
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
Estimated Primary Completion Date : February 25, 2020
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. Compare patient-reported outcomes (PROs) between patients diagnosed with DCIS who received GCC to patients diagnosed with ADH and LCIS/ALH in a cross-sectional patient cohort at 3 selected study sites. [ Time Frame: 2 years ]
    The primary outcome will be measuring severity of chronic pain.


Secondary Outcome Measures :
  1. Measure the incremental utility of GCC compared to AS according to a preference-based quality-adjusted life year metric (QALY). [ Time Frame: 2 years ]
    Quality of life (QOL) measuring of utility including Patient Reported Outcomes (PROs).

  2. Quality of life (QOL) measuring of utility including Patient Reported Outcomes [ Time Frame: 2 years ]
    Patient Reported Quality of Life.



Information from the National Library of Medicine

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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, or MDACC 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 September 30, 2016
  • 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:

  • Diagnosis of invasive or microinvasive breast cancer prior to January 1, 2012 or after the index lesion diagnosis, between January 1, 2012 and September 30, 2016
  • Other cancers (excluding non-melanoma skin cancer) diagnosed within 5 years prior to index lesion and up to the present time
  • 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
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Study Director: Ann H. Partridge, MD, MPH Dana-Farber Cancer Institute

Responsible Party: Ann H. Partridge, MD, MPH, Director, Adult Survivorship Program, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03070236     History of Changes
Other Study ID Numbers: 16-571
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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