Promoting Cancer Symptom Management in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Symptom Severity Change Over Time
研究概览
简要总结
The purpose of the project is to estimate the effect size of a technology based intervention for older adults with cancer for nausea and vomiting. Participants will be randomized to either an intervention or a wait control group. Outcomes such as symptom severity, quality of life and resource use will be examined.
详细描述
The goal of this study is to increase the self-management behaviors for chemotherapy induced nausea and vomiting (CINV) and reduce treatment-related negative outcomes in older adults with cancer. CINV is a common reason for unplanned emergency department and/or hospital admissions in older adults with cancer. Early reinforcement of standard education and reframing preconceived beliefs about the potential serious consequences of CINV and the symptoms ability to be successfully managed will increase effective self-management behaviors and improve patient outcomes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women age 65 and older
- •newly diagnosed with any cancer
- •treatment with any chemotherapeutic agent with a moderate to severe emetic potential (on a 3- or 4- week cycle)
- •proficient in English
- •have a telephone.
排除标准
- •Patients with previous diagnosis and treatment for cancer
- •advanced or end stage disease with a palliative intent
- •visually or hearing impaired.
研究组 & 干预措施
Intervention group
electronic Symptom Self-Management Training- CINV (eSSET-CINV) is an educational intervention administered once at the start of treatment
干预措施: eSSET-CINV (Other)
Wait Control group
The Wait control group receives the electronic Symptom Self-Management Training- CINV (eSSET-CINV) at the last study visit. Outcomes will be compared to the Intervention group at the end of the study.
干预措施: eSSET-CINV (Other)
结局指标
主要结局
Symptom Severity Change Over Time
时间窗: assessed at baseline (week 1), week 4,week 7, week 10. differences between groups at week 10 are being reported
Symptom Representation Questionnaire (SRQ)\[20\] , a 24-item self-report measure will be used to identify presence and severity of common treatment-related symptoms (0-10 Likert scale), including nausea and vomiting (N/V). This measure asks respondents to think about their symptoms over the past week. Higher values indicate a worse outcome
Self-management Behaviors Over Time
时间窗: data was assessed at weeks 4,7, 10, the mean number of behaviors (behaviors) combined at each time point is reported
An investigator-developed Symptom Management Checklist (SMC) will measure CINV self-management prevention behaviors. Participants will complete this daily at home between chemotherapy cycles. Higher numbers indicate more frequent management.
Health-related Quality of Life Change Over Time
时间窗: assessed at baseline (week 1), week 4, week 7, week 10. the difference between groups at week 10 is being reported
The EORTC-30\[21\] will measure QOL at each treatment cycle. 0-10 scale, higher scores mean better outcome
Resource Use Over Time
时间窗: assessed at weeks 4,7,10. the total number of admissions was summed across all time points and participants
Any unplanned Emergency Department or hospital admission will be recorded via participant report. Higher number indicate higher resource use.
次要结局
未报告次要终点