Symptom Burden in Patients With Cancer- and Treatment-Related Skin Problems
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Severity of Multiple Symptoms/Impact of Symptoms on Daily Functioning
研究概览
简要总结
Objectives:
The objective of this study is to develop a valid and reliable measure of the symptom burden experienced by patients with cancer experiencing disease-related skin problems and to delineate this burden over time.
The Primary Aim is to develop and validate an M.D. Anderson Symptom Inventory (MDASI) module (the MDASI-Derm), compliant with FDA standards for patient-reported outcomes (PROs), to measure the severity of multiple symptoms and the impact of these symptoms on daily functioning in patients with cancer-related skin problems. We hypothesize that the MDASI-Derm will be valid and reliable for measuring the severity of multiple symptoms and the impact of these symptoms on daily functioning in patients with cancer-related skin problems.
The Secondary Aims are:
- to develop a detailed description of the severity and interference with daily activities of symptoms experienced by patients with cancer-related skin problems;
- to assess the impact of symptom severity on standard function and quality of life (QOL) measures including both quantitative (Eastern Cooperative Oncology Group [ECOG] Performance Status, single-item QOL, and Skindex-16 scales) and qualitative measures (patient interviews);
- to evaluate the MDASI-Derm as an estimate of functional status and QOL in patients with cancer-related skin problems;
- to identify common clusters of symptoms and symptom patterns occurring over multiple measurement time points in patients with cancer-related skin problems;
- to define the qualitative symptom experience of patients with cancer-related skin problems;
- to explore the feasibility of the Interactive Voice Response (IVR) system in measuring symptom severity and interference with daily activities over time in patients with cancer-related skin problems.
详细描述
Part I:
Interview:
If you agree to take part in this study, while you are at the clinic for a visit, you will be interviewed about skin problems and other symptoms that you have had since you began experiencing skin problems. The interview should take about 30 minutes to complete.
Part I:
Questionnaires:
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
- 否
入选标准
- •18 years of age or older
- •Ability to read and speak English
- •Receiving treatment and/or follow up at M. D. Anderson Cancer Center
- •Residing where IVR service is available (Validation part of study only)
- •Rating of skin problem at its worse in the last 24-hours of at least 1 on a 0 to 10 scale where 0 is no skin problem and 10 is the skin problem as bad as can be imagined
- •Written consent to participate
排除标准
- •Medical condition (impaired speech that would preclude taking part in a 30 minute interview, deafness that would impair the ability to use the IVR system) or impaired performance status that would preclude participation in the study
- •Diagnosis of active psychosis or severe cognitive impairment as determined by physician
- •Active treatment (systemic drug therapy or radiation therapy) for a second malignancy
结局指标
主要结局
Severity of Multiple Symptoms/Impact of Symptoms on Daily Functioning
时间窗: 1 year
MDASI-Derm measure of severity + impact of 13 cancer-related core symptoms that cause most interference with daily activities; Severity of symptoms rated (with amount of interference with daily living) on scales from 0 to 10, with 0 meaning no symptom or interference and 10 meaning as severe or complete interference.
次要结局
未报告次要终点