PORTAL: Patient-reported Outcomes After Routine Treatment of Atypical Lesions
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 912
- 试验地点
- 6
- 主要终点
- The Primary Outcome Measures Severity of Chronic Pain.
研究概览
简要总结
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))
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Patient-reported Outcomes Survey
The survey will administered online, over the phone, or via mail.
干预措施: Survey (Other)
结局指标
主要结局
The Primary Outcome Measures Severity of Chronic Pain.
时间窗: 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.
次要结局
未报告次要终点
研究者
Ann H. Partridge, MD, MPH
Director, Adult Survivorship Program
Dana-Farber Cancer Institute