Chemoradiation-Induced Nausea and Emesis: A Prospective Study to Assess Patient Preferences and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Longitudinal Quality of Life + Symptom Assessment Data
研究概览
简要总结
The primary objectives of this study are:
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To assess the preferences of cancer patients scheduled to receive chemoradiation and caregiver controls for side-effects of chemoradiation.
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To compare preferences of cancer patients to those of healthy individuals.
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To compare how patients' preferences for side-effects of chemoradiation change over time.
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To longitudinally assess the quality of life of cancer patients scheduled to receive chemoradiation.
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To determine the impact of nausea and vomiting associated with chemoradiation on patients' quality of life and evaluate potential change throughout the duration of chemoradiation treatment.
详细描述
You will be interviewed about your perceptions of side effects that are related to your chemoradiation treatment. The interview will take about 20 minutes. You will be interviewed at the beginning of your chemoradiation treatment, 3 weeks after treatment starts, and at the first follow-up appointment after chemoradiation treatment ends.
Chemoradiation is a type of cancer treatment that involves both chemotherapy and radiation therapy.
You will also receive a packet of 3 questionnaires to complete at different times during and after treatment. The questionnaires include a quality of life survey that asks about physical, social, and emotional well-being, a self-report symptom evaluation that will ask whether you are experiencing any particular side effects and if so how much it bothers you, and a brief survey to asks questions about anxiety and distress.
The questionnaires should take about 20 minutes each to complete. The questionnaire packet will be given to patients at the beginning of chemoradiation treatment, 3 weeks after treatment starts, the last day of treatment, and at the first follow-up appointment after chemoradiation treatment ends. If the you do not have time to complete the questionnaires, a stamped, addressed envelop will be given so that you can mail the completed packet back to the research team.
Your participation in this research study will be over about 4-6 weeks after chemoradiation treatment ends.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients receiving 5 to 6-week course of chemoradiation for abdominal-pelvic tumors (gastric cancers, gastro-esophageal (GE) junction, pancreatic, cervix, vulvar, endometrial, or anal) using conventional fractionation [(180cGy-200cGy per day)]
- •Patients receiving concurrent abdominal-pelvic radiation and single agent or combination of cisplatin, paclitaxel, CPT-11, oxaliplatin or 5-FU, capecitabine, gemcitabine, or bevacizumab (Avastin).
- •Patients must be least 18 years of age
- •Controls must be individuals with no prior cancer diagnosis
- •Controls must be at least 18 years of age
- •Controls must be the caregivers of patients on this study
排除标准
- •Patients who do not have a diagnosis of cervix, endometrial, vulvar or anal cancer
- •Patients who are not scheduled to receive chemoradiation treatment
- •Patients who are not at least 18 years of age
- •Controls - individuals who have a prior diagnosis of cancer (with the exception of non-melanoma skin cancer)
- •Controls - individuals who are not at least 18 years of age
结局指标
主要结局
Longitudinal Quality of Life + Symptom Assessment Data
时间窗: Survey(s) & Interview(s) at baseline (beginning of chemoradiation treatment), 3 weeks after treatment starts, the last day of treatment, and at the first follow-up appointment after chemoradiation treatment ends.
Quality of life survey instruments scored according to EORTC QLQ-C30 scoring manual. Patients and controls compared with respect to preference data. The control group preference data collected at only 1 time point, but patient preference data from each time point will be compared to these control group preference data.
次要结局
未报告次要终点