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

• Sponsor: Dana-Farber Cancer Institute (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03070236
• Collaborator: (none)
• Enrollment: 912
• Locations: 6
• Arm: 1
• Anticipated Duration (Months): 62.8
• Patients Per Site: 152
• Patients Per Site Per Month: 2.4

Study Details

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))

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Other: Survey	N/A

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 Design

• Study Type: Interventional
• 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: Dec 1, 2017
• Actual Primary Completion Date: May 27, 2019
• Anticipated Study Completion Date: Feb 25, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The Primary Outcome Measures Severity of Chronic 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.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
2	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215
3	Newton-Wellesley Hospital	Newton	Massachusetts	United States	02462
4	Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital	Weymouth	Massachusetts	United States	02198
5	Duke University Medical Center	Durham	North Carolina	United States	27710
6	MD Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• Dana-Farber Cancer Institute

Investigators

• Study Director: Ann H. Partridge, MD, MPH, Dana-Farber Cancer Institute

Study Documents (Full-Text)

• Study Protocol - May 20, 2019
• Statistical Analysis Plan - May 20, 2019

More Information

Publications

None provided.

• 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: Mar 3, 2017
• Last Update Posted: May 24, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• 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, Director, Adult Survivorship Program, Dana-Farber Cancer Institute: Breast Cancer
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

Participant Flow

Arm/Group Title	Guideline Concordant Care (GCC) & Active Surveillance (AS)
Arm/Group Description	Guideline Concordant Care (GCC): Women who receive a combination of surgery, radiation and hormonal therapy - treatments similar to those recommended to patients with invasive cancer. Active Surveillance (AS): Women who receive a treatment strategy, under study for management of low-risk DCIS, that does not include surgery or radiation.
Period Title: Overall Study
STARTED	912
Guideline Concordant Care (GCC) Arm	538
Active Surveillance (AS) Arm	374
COMPLETED	912
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Guideline Concordant Care (GCC)	Active Surveillance (AS)	Total
Arm/Group Description	Women who receive a combination of surgery, radiation and hormonal therapy - treatments similar to those recommended to patients with invasive cancer.	Women who receive a treatment strategy, under study for management of low-risk DCIS, that does not include surgery or radiation.	Total of all reporting groups
Overall Participants	538	374	912
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	60.7	58.4	59.8
Sex: Female, Male (Count of Participants)
Female	538 100%	374 100%	912 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	31 5.8%	19 5.1%	50 5.5%
Not Hispanic or Latino	503 93.5%	350 93.6%	853 93.5%
Unknown or Not Reported	4 0.7%	5 1.3%	9 1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	22 4.1%	20 5.3%	42 4.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	40 7.4%	15 4%	55 6%
White	459 85.3%	330 88.2%	789 86.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	17 3.2%	9 2.4%	26 2.9%
Region of Enrollment (participants) [Number]
United States	538 100%	374 100%	912 100%

Outcome Measures

1. Primary Outcome

Title	The Primary Outcome Measures Severity of Chronic Pain.
Description	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.
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Guideline Concordant Care (GCC)	Active Surveillance (AS)
Arm/Group Description	Women who receive a combination of surgery, radiation and hormonal therapy - treatments similar to those recommended to patients with invasive cancer.	Women who receive a treatment strategy, under study for management of low-risk DCIS, that does not include surgery or radiation.
Measure Participants	538	374
Mean (Full Range) [Composite Score]	6.4	3.0

Adverse Events

Time Frame	Approximately 19 months
Arm/Group Title	Guideline Concordant Care (GCC) & Active Surveillance (AS)
Arm/Group Description	Guideline Concordant Care (GCC): Women who receive a combination of surgery, radiation and hormonal therapy - treatments similar to those recommended to patients with invasive cancer. Active Surveillance (AS): Women who receive a treatment strategy, under study for management of low-risk DCIS, that does not include surgery or radiation.
All Cause Mortality
	Guideline Concordant Care (GCC) & Active Surveillance (AS)
	Affected / at Risk (%)	# Events
Total	0/912 (0%)
Serious Adverse Events
	Guideline Concordant Care (GCC) & Active Surveillance (AS)
	Affected / at Risk (%)	# Events
Total	0/912 (0%)
Other (Not Including Serious) Adverse Events
	Guideline Concordant Care (GCC) & Active Surveillance (AS)
	Affected / at Risk (%)	# Events
Total	0/912 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.