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

Primary Purpose

Breast Cancer

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Survey

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Massachusetts General Hospital
Dana-Farber Cancer Institute
Newton-Wellesley Hospital
Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital
Duke University Medical Center
MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient-reported Outcomes Survey

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03070236

First Posted

February 16, 2017

Last Updated

October 9, 2023

Sponsor

Dana-Farber Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT03070236

Brief Title

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

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 1, 2017 (Actual)

Primary Completion Date

May 27, 2019 (Actual)

Study Completion Date

February 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dana-Farber Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Breast Cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

912 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patient-reported Outcomes Survey

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Survey

Intervention Description

Select questions will be ask in the survey

Primary Outcome Measure Information:

Title

The Primary Outcome Measures Severity of Chronic Pain.

Description

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.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ann H. Partridge, MD, MPH

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Study Director

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Newton-Wellesley Hospital

City

Newton

State/Province

Massachusetts

ZIP/Postal Code

02462

Country

United States

Facility Name

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

City

Weymouth

State/Province

Massachusetts

ZIP/Postal Code

02198

Country

United States

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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