Serious Gaming for Chemotherapy-induced Nausea and Vomiting in Older Adults With Cancer: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 610
- 试验地点
- 4
- 主要终点
- CINV severity
研究概览
简要总结
The purpose of this study is to examine the effectiveness of a technology-based intervention for managing nausea and vomiting in older adults with cancer. Participants will be randomized to either an intervention or 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 use of preventative self-management behaviors for nausea and vomiting in older adults receiving chemotherapy to reduce negative outcomes and emergency or hospital admissions. Early reinforcement of standard education and re-framing any preconceived beliefs about the ability of nausea and vomiting to be managed will increase preventative self-management behaviors and improve patient outcomes. Participants will be in the study for 6 chemotherapy treatment cycles. This could be 12 to 24 weeks depending on if they receive treatment every 2, 3 or 4 weeks.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 60 or older
- •newly diagnosed with cancer
- •treatment with any chemotherapeutic agent of moderate or high emetic potential
- •on a 2, 3 or 4 week treatment cycle
- •proficient in English
- •has a telephone
排除标准
- •previous diagnosis and/or treatment for cancer
- •end stage disease with less than 6 months to live
- •visually or hearing impaired without corrective device
研究组 & 干预措施
Intervention
This intervention is a serious game which allows older adults under treatment for cancer to practice making self-care decisions for an avatar that is being sent home after their first chemotherapy treatment. This serious game is coupled with a discussion with the research assistant about choices related to managing nausea and vomiting at home
干预措施: eSSET-CINV (Behavioral)
Control
The control group will receive standard education related to managing nausea and vomiting and will have the opportunity to participate in the intervention at the end of the study
干预措施: eSSET-CINV (Behavioral)
结局指标
主要结局
CINV severity
时间窗: From baseline1 through the end of the study at 12 or 24 weeks
The Symptom Management Checklist will measure the presence and severity of nausea and vomiting. Participants will be sent a text link every day for 6 days after chemotherapy or complete this data on a form at home. This starts right after time 1. Nausea will be reported on a 0-10 scale. Higher numbers equal more nausea.
Healthcare resource use
时间窗: From baseline through the end of the study at 12 or 24 weeks
any emergency department or hospital admission will be recorded using a dichotomous variable (yes/no)
次要结局
- Health-related Quality of Life(baseline, 4,8,12,16,20, and 24 weeks)
- Self-management behaviors(From baseline through the end of the study at 12 or 24 weeks)
- Symptom severity(Baseline and 12 or 24 weeks)
- Cognitive representation(Baseline and 12 or 24 weeks)