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临床试验/NCT04627077
NCT04627077已完成不适用

Livestrong Cancer Institutes' Patient Reported Outcomes Study

University of Texas at Austin1 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2018年1月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
121
试验地点
1
主要终点
Change in Quality of Life - FACT-G

研究概览

简要总结

The goal of this study will be to collect baseline patient reported outcome measures at the Livestrong Cancer Institutes (LCI) with the goal of improving quality care and to inform decision making by patients, providers, and researchers for future LCI initiatives.

详细描述

This proposed study is a descriptive study of the adult oncology population at the Seton Infusion Center in order to provide information about patient needs and identify areas for further research and resource allocation. The patient reported outcome measures being collected cover the following domains: anxiety, depression, fatigue, physical function, financial toxicity and pain. Patients and caregivers will be informed about the study and given the opportunity to enroll at the time of routine clinic visits at the Dell Seton Medical Center at The University of Texas Seton Infusion Center (SIC). Patients choosing to enroll in the study will be provided informed consent, and then allowed to complete the measures during their clinic visit on an iPad provided by the research staff. After IRB approval for a period of 1-2 months data collection will take place at the SIC clinic at DMS. Upon completion of the measures patients will be asked for an email address and phone number so that a follow up link to survey questions can be sent to them in 3 months.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient aged 18 years and older, being treated for cancer at the Seton Infusion Clinic
  • Patient cognitively and physically able to complete questionnaires on an ipad in English or Spanish.

排除标准

  • -Patient unable to speak English or Spanish as required for study data collection
  • Patient cognitively or physically unable to complete measures

结局指标

主要结局

Change in Quality of Life - FACT-G

时间窗: Baseline

Functional Assessment of Cancer Therapy (FACT-G)

Change in Depression - PROMIS

时间窗: Baseline and 3 month follow up

PROMIS adaptive Depression

Change in Physical Function- PROMIS

时间窗: Baseline and 3 month follow up

PROMIS adaptive physical function

Change in Fatigue - PROMIS

时间窗: Baseline and 3 month follow up

PROMIS adaptive fatigue

Change in Patient satisfaction with care

时间窗: Baseline and 3 month follow up

The CAHPS® Cancer Care Survey

Change in Financial Toxicity

时间窗: Baseline and 3 month follow up

Comprehensive Score for financial Toxicity (COST) questionnaire

Change in Anxiety - PROMIS

时间窗: Baseline and 3 month follow up

PROMIS adaptive anxiety

Change in Pain - PROMIS

时间窗: Baseline and 3 month follow up

PROMIS adaptive pain

次要结局

  • Change in Impact on Caregivers(Baseline and 3 month follow up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gail Eckhardt

Director, LIVESTRONG Cancer Institutes Chair, Department of Oncology

University of Texas at Austin

研究点 (1)

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