Measuring the Symptom Distress of Cancer Patients: Development of a New Assessment System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6,500
- 试验地点
- 1
- 主要终点
- MD Anderson Symptom Inventory (MDASI) tool or other MD Anderson-developed PRO instrument reliability.
研究概览
简要总结
This trial studies how well a new assessment system (MDASI or other MD Anderson-developed PRO instrument) works in measuring symptoms and the impact on quality of life in cancer patients. Development of a new assessment system may provide more information about the common symptoms that may occur in patients due to cancer and its treatment and how the symptoms impact quality of life.
详细描述
PRIMARY OBJECTIVES:
I. To examine how the MD Anderson Inventory (MD Anderson Symptom Inventory [MDASI]) or other MD Anderson-developed patient reported outcome (PRO) instrument performs in various sample populations including community dwelling adults and patients who have different cancer types, who have undergone various treatments, and who have different and/or more severe symptoms.
II. To evaluate the MDASI or other MD Anderson-developed PRO instrument as an estimate of functional status and quality of life.
III. To assess the impact of symptom severity on standard function and health-related quality of life measures, including both quantitative and qualitative measures (patient interviews).
IV. To assess the pattern and severity of symptoms over multiple time points in order to assay the system's responsiveness to changes due to therapy or disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •NORMAL SAMPLES: Community dwelling adults 18 years of age or older
- •PATIENT SAMPLES: Inpatients and outpatients 18 years of age or older, being followed at UT MD Anderson
- •EXPERT PANEL PROFESSIONAL PARTICIPANTS: Physician or other healthcare provider with at least 5 years of experience caring for patients with the disease and/or treatment of interest, at least one publication in the last 5 years dealing with the disease and/or treatment of interest (physician only), ability to speak and read English, consent to participate
- •EXPERT PANEL FAMILY CAREGIVERS PARTICIPANTS: Identification as a family caregiver by patient enrolled as expert panel participant with the disease and/or treatment of interest, 18 years of age or older, ability to speak and read English, consent to participate
- •EXPERT PANEL PATIENT PARTICIPANTS: Patient with identified family caregiver participating on Expert Panel, willingness to receive packet for expert panel participation
排除标准
- •EXPERT PANEL PATIENT PARTICIPANTS: Patient with identified family caregiver participating on expert panel, willingness to receive packet for expert panel participation
研究组 & 干预措施
Observational (questionnaire, QOL assessment, interview)
Participants complete questionnaires and quality of life assessments, and may also complete interviews over 45 minutes periodically.
干预措施: Interview (Other)
Observational (questionnaire, QOL assessment, interview)
Participants complete questionnaires and quality of life assessments, and may also complete interviews over 45 minutes periodically.
干预措施: Quality-of-Life Assessment (Other)
Observational (questionnaire, QOL assessment, interview)
Participants complete questionnaires and quality of life assessments, and may also complete interviews over 45 minutes periodically.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
MD Anderson Symptom Inventory (MDASI) tool or other MD Anderson-developed PRO instrument reliability.
时间窗: Up to 21 years
Each item is rated 0 to 10 with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imaged or complete interference. The symptom severity and interference sub scales are mean values of the items in each scale. Hence the range of each sub scale is also 0 to 10. Lower values represent a better outcome. Higher values represent a worse outcome. The symptom severity and interference sub scales are not combined to compute a total score.
MD Anderson Symptom Inventory (MDASI) tool or other MD Anderson-developed PRO instrument sensitivity
时间窗: Up to 21 years
Each item is rated 0 to 10 with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imaged or complete interference. The symptom severity and interference sub scales are mean values of the items in each scale. Hence the range of each sub scale is also 0 to 10. Lower values represent a better outcome. Higher values represent a worse outcome. The symptom severity and interference sub scales are not combined to compute a total score.
The quality of life questionnaire will be assessed.
时间窗: Up to 21 years
The European Organization for Cancer Treatment and Research Quality of Life scale (EORTC QLQ-C30) is a quality of life questionnaire that measures five functional areas (physical, social, role, cognitive, and emotional), eight symptoms (fatigue, nausea/vomiting, pain, dyspepsia, sleep disturbance, diarrhea, appetite loss, and constipation), financial impact, and overall quality of life. All of the sub scales and single-item measures range in score from 0 to 100 according to scoring algorithms.
Eastern Cooperative Oncology Group Functional Status scale
时间窗: Baseline up to 21 years
6-point 0-5 scale; lower score = better outcome.
MD Anderson Symptom Inventory (MDASI) tool or other MD Anderson-developed patient reported outcome (PRO) instrument validity
时间窗: Up to 21 years
Each item is rated 0 to 10 with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imaged or complete interference. The symptom severity and interference sub scales are mean values of the items in each scale. Hence the range of each sub scale is also 0 to 10. Lower values represent a better outcome. Higher values represent a worse outcome. The symptom severity and interference sub scales are not combined to compute a total score.
MD Anderson Symptom Inventory
时间窗: Baseline up to 21 years
Mean ratings of 11-point 0-10 scales; lower mean score = better outcome.
EuroQOL 5 Dimensions questionnaire
时间窗: Baseline up to 21 years
Scored on 5-point 1 to 5 scales; combined scores converted to index value for US = -0.573 to 1; higher values = better outcome.
The change in the symptom severity and interference with the function
时间窗: Baseline up to 21 years
Changes in patients' symptoms over time will be determined by differences in symptom severity scores on the MD Anderson Symptom Inventory MDASI collected at multiple time points. 0 to 10 with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imaged or complete interference. The symptom severity and interference sub scales are mean values of the items in each scale. Hence the range of each sub scale is also 0 to 10. Lower values represent a better outcome. Higher values represent a worse outcome. The symptom severity and interference sub scales are not combined to compute a total score.
次要结局
未报告次要终点