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 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: Survey||Not Applicable|
|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|
Experimental: Patient-reported Outcomes Survey
The survey will administered online, over the phone, or via mail.
Select questions will be ask in the survey
- 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.
- 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).
- Quality of life (QOL) measuring of utility including Patient Reported Outcomes [ Time Frame: 2 years ]Patient Reported Quality of Life.
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
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Study Director:||Ann H. Partridge, MD, MPH||Dana-Farber Cancer Institute|