跳至主要内容
临床试验/NCT02515383
NCT02515383进行中(未招募)不适用

Preliminary Testing of the MD Anderson Symptom Inventory (Adolescent Version)

M.D. Anderson Cancer Center2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2016年11月9日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
41
试验地点
2
主要终点
Performance of MD Anderson Symptom Inventory (MDASI) modified for use with adolescents (adolescent version)

研究概览

简要总结

This study investigates how the MD Anderson Symptom Inventory questionnaire modified for use with adolescents performs in adolescent patients with cancer. Conducting interviews with adolescents about the MD Anderson Symptom Inventory may help researchers improve the questionnaire to better understand the symptoms experienced by 13-17 year old patients with cancer.

详细描述

PRIMARY OBJECTIVE:

I. To examine how the MD Anderson Symptom Inventory (MDASI) modified for use with adolescents (adolescent version) performs in adolescent patients who have various cancer types, who have undergone various treatments, and who have varying levels of symptom burden.

SECONDARY OBJECTIVES:

I. To explore the feasibility of various methods for collecting MDASI (adolescent version) data (for example, paper-and-pencil forms, face-to-face and telephone interviews, electronic data capture methods such as electronic tablets or automated telephone systems.

II. To evaluate the MDASI (adolescent version) as an estimate of functional status and quality of life in adolescent cancer patients.

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
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Ability to speak and read English
  • Diagnosis of cancer, confirmed pathologically or clinically
  • Being seen by a healthcare provider at MD Anderson Cancer Center
  • Written assent by subject and written consent by parent/guardian for participation
  • Starting a cycle of chemotherapy, starting radiation therapy, or starting preparative regimen for stem cell transplantation (Part 2 only)

排除标准

  • Medical condition, as determined by the attending physician, that would preclude participation in the study
  • Diagnosis of active psychosis, developmental delay, or severe cognitive impairment documented by primary physician in medical record

结局指标

主要结局

Performance of MD Anderson Symptom Inventory (MDASI) modified for use with adolescents (adolescent version)

时间窗: Up to 3 months

Data analysis for the cognitive debriefing portion of the study will be qualitative in nature. Construct validity will be determined using factor analysis. Internal consistency reliability will be assessed using Cronbach coefficient alphas.

次要结局

  • Evaluation of the MDASI (adolescent version) as an estimate of functional status and quality of life(Up to 3 months)
  • Feasibility of collection methods(Up to 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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