Impact of Routine Electronic Patient-Reported Outcome (ePRO)Symptom Monitoring During Neoadjuvant Therapy in Patients withPancreatic Adenocarcinoma on Patient Experience and ClinicalOutcomes: A Prospective Pre-Post Implementation Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- safety and adverse events (AEs)
研究概览
简要总结
To learn if routine symptom monitoring using questionnaires during chemotherapy and/or radiation therapy in patients with PDAC improves patient health-related quality of life and experience with care.
详细描述
2.1 Primary Objectives • To determine whether implementing routine ePRO symptom monitoring during NAT in patients with PDAC improves patient health-related quality of life (HRQoL) and experience with care compared with the pre-implementation period.
o To capture participant HRQoL and experience, the primary outcomes will be measured using the PROMIS-16 and CAHPS Cancer Care Survey , respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria
- •Age ≥18 years
- •Participants must have histologically confirmed PDAC that is respectable, borderline respectable, or locally advanced with potential for curative intent resection as defined by MD Anderson Cancer Center (Appendix V)
- •Participants must be eligible to receive systemic neoadjuvant therapy (chemotherapy +/- radiation therapy) with intent for curative resection
- •Participants who will receive neoadjuvant therapy at an MD Anderson facility including Texas Medical Center and Houston area locations
- •Participants must be able to understand English or Spanish
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Definitively unresectable or metastatic disease at enrollment
- •Participants who received pre-referral chemotherapy, chemoradiotherapy, or previously attempted resection
- •Participants who had prior curative intent surgery for pancreatic cancer before entering the study
- •Participant with cognitive deficits that would preclude understanding of consent form and/or questionnaires
- •Participants with psychiatric illness/social situations that would limit compliance with study requirements
- •Participants who do not understand English or Spanish
- •Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia
- •Participants with uncontrolled underlying medical conditions
- •Participants receiving chemotherapy outside of the MD Anderson system
研究组 & 干预措施
Post-Implementation Cohort
Standard Clinical Care + QW ePRO
干预措施: Standard of Care (Other)
Pre-Implementation Cohort
Standard Clinical Care
干预措施: Standard of Care (Other)
结局指标
主要结局
safety and adverse events (AEs)
时间窗: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点