Qualitative Techniques to Define Meaningful Within-Patient Change in Symptoms of Advanced Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Functional Assessment of Cancer Therapy - General (FACT-G) scores
研究概览
简要总结
This study examines qualitative techniques in defining meaningful within patients changes in symptoms in patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). This study may help researcher better understand how to interpret reports from patients about their cancer symptoms and treatment side effects.
详细描述
PRIMARY OBJECTIVES:
I. To develop method to establish meaningful change in patient-reported outcomes (PROs).
II. To provide responder definitions in 2 ways:
IIa: Detectable change: within patient score change patients perceive but does not exceed a subjective threshold for a modification to patient care (for worsening) or conclusion of achieving therapeutic benefit (for improvement); IIb. Meaningful change: within patient score change that patients perceive and that does require modification in management (for worsening) or supports conclusion of therapeutic benefit (improvement).
OUTLINE: This is an observational study. Participants are assigned to 1 of 2 groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 with a diagnosis of cancer including solid tumor and hematologic malignancy at Mayo Clinic, Rochester
- •To ensure sampling patients likely to have experienced declines in fatigue, all patients will have had at least two in-person encounters for radiation or chemotherapy treatment within the 3 months prior to recruitment. The sampling methodology developed for the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Cancer Care survey will be modified and used to identify eligible patients from Mayo Clinic's electronic health record
- •As interviews will be conducted either in person or by video conference (Zoom, Teams, or similar), access to internet is required for those unable or unwilling to travel to the clinic for an in-person interview
- •Answered "Yes" to screening question: "In the past 3 months, have you experienced changes in your level of fatigue?" Yes/No
- •PATIENT ADVOCATES:
- •Patient advocates recommended by the FDA to provide their input to help us in reaching a consensus in the way we define meaningful change (both improvement and decline) that came from patients in the first arm
排除标准
- •Unwilling to be audio recorded during the interviews
- •Answered "No" for the screening question
结局指标
主要结局
Change in Functional Assessment of Cancer Therapy - General (FACT-G) scores
时间窗: Baseline
The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire that measures four domains of Health-Related Quality of Life (HRQOL) in cancer patients: physical, social, emotional, and functional well-being. Questions are answered with a 0-4 scale where 0=Not at all and 4=Very much. Scores will be evaluated for worsening from good days (baseline) and improvement from bad days (baseline).
Meaningful change in patient reported outcomes (PROs)
时间窗: Baseline
Change in PROs will be assessed using the critical incident technique (CIT) during semi-structured interviews as a means of educating, training, and evaluating patients on the concept of meaningful change. Interviews will be summarized to record how patients explain the concept of meaningful improvement and declines in their own words.
Change in Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) scores
时间窗: Baseline
PRO-CTCAE is a patient-reported outcome (PRO) measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials. It was designed to be used as a companion to the Common Terminology Criteria for Adverse Events (CTCAE). Scores will be evaluated for worsening from good days (baseline) and improvement from bad days (baseline).
次要结局
未报告次要终点