Using PROMIS as Part of Routine Clinical Care for Racially Diverse Prostate and Bladder Cancer Patients
LCCC 1636: Using PROMIS as Part of Routine Clinical Care for Racially Diverse Prostate and Bladder Cancer Patients
研究概览
详细说明
Cancer treatments, including surgery, radiotherapy and chemotherapy, are often linked to acute and late side effects. Historically, these effects were assessed by physicians and scored using standardized scales such as the Common Terminology Criteria for Adverse Events (CTCAE). Thorough and accurate assessment of symptoms facilitates timely and patient-centered symptom management.
Multiple studies have demonstrated that PROs more accurately capture patient symptoms than physician assessment. In a prospective trial, Falchook et al. investigated patient vs. physician report of symptoms in head and neck cancer patients undergoing radiotherapy (N=44). Patients and physicians separately completed weekly symptom assessments during treatment and once during follow-up. Patients tended to report more severe symptoms than physicians. For example, in week six, physicians rated 86% of patients' fatigue as non-existent or mild while 86% of patients rated their own fatigue as moderate to very severe. In a larger study conducted at Memorial Sloan-Kettering Cancer Center of 163 lung cancer patients undergoing chemotherapy, Basch et al. similarly examined patient vs. physician report of symptoms over one year. Compared to patients, physicians reported less severe and lower rates of fatigue, nausea, and pain and higher functional status.
Findings from these prior studies are consistent with evidence from a recent systematic review, which concluded that PRO data were essential for the evaluation of symptoms in cancer survivors. Many researchers have hypothesized the reasons behind this discrepancy in physician/patient ratings of symptoms, including poor communication, inadequate physician time spent per patient, and patients' underreporting of symptoms to physicians. Thus, incorporation of PRO data into routine clinical care can facilitate better detection and management of cancer and treatment-related effects.
Therefore, the goal of this pilot study is to move PRO data collection from a purely research exercise into using this as a tool to improve care for cancer patients. This pilot study will assess the feasibility of collecting PRO data as part of clinical care, and assess its "value" from the patient and physician perspectives. The investigators will recruit 80 patients with prostate or bladder cancers from the UNC Genitourinary Oncology clinics (including Urology and Radiation Oncology). PRO data that is most relevant to this patient population will be collected, including: gastrointestinal, urinary, sexual function, anxiety/depression, and sleep.
Further, given longstanding racial disparities in symptom experiences (e.g., symptom assessment, severity, frequency) among cancer patients and limited evidence of effective strategies for mitigating such inequities, this pilot study will also examine Black-White differences in terms of the feasibility and perceived value of sharing of patient-reported data to improve communication and decision-making.
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
North Carolina
-
Chapel Hill、North Carolina、美国、27599
- Becky Green
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 18 years or older
- Non-Hispanic Black and White patients with a known pathologic diagnosis of prostate or bladder cancer and intent to undergo treatment.
- Signed, IRB approved written informed consent.
Exclusion Criteria:
- Initiation of cancer-directed treatment
- Race/ethnicity other than Non-Hispanic Black or Non-Hispanic White
- Inability to read and speak English
- Inability to comply with study for any other reason than language
- Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
---|
Caucasian
This cohort will consist of 40 white patients who are receiving either radiation or surgery for treatment of their prostate or bladder cancer.
|
African American
This cohort will consist of 40 African American patients who are receiving either radiation or surgery for treatment of their prostate or bladder cancer.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Feasibility of PRO assessments in a clinical setting
大体时间:90 days post treatment
|
The feasibility of incorporating PRO assessments into the clinical setting for 80 Black and White patients undergoing treatment for bladder and prostate cancer.
Feasibility is defined as at least 70% of study participants completing all three PRO assessments.
|
90 days post treatment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Feasibility of enrollment
大体时间:baseline
|
The feasibility of enrolling bladder and prostate cancer patients into PRO assessment for clinical care.
Feasibility of enrollment is defined as at least 37.56% of eligible patients who are approached about the study agree to enroll.
|
baseline
|
Preferred mode of questionnaire completion
大体时间:baseline through 90 days post treatment
|
The proportion of study participants who chose web vs. interactive voice response (IVR) as the preferred mode for PRO data collection.
It is hypothesized 50% of patients will chose the web.
|
baseline through 90 days post treatment
|
Feasibility by cohort
大体时间:baseline through 90 days post treatment
|
The rates of the feasibility of PRO assessment, the feasibility of enrollment, and preferred mode of PRO assessment in Black vs. White patients.
|
baseline through 90 days post treatment
|
Perceived value
大体时间:baseline through 90 days post treatment
|
Patterns and Black vs. White differences in the perceived value of PRO assessments from the patient's perspective using semi-structured interviews.
|
baseline through 90 days post treatment
|
合作者和调查者
调查人员
- 首席研究员:Ronald Chen, MD、University of North Carolina, Chapel Hill
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.