Psychometric and Linguistic Validation of PRO-AYA: Patient-Reported Outcomes for Adolescents and Young Adults (15-39) With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 7
- 主要终点
- Test-retest reliability
研究概览
简要总结
The purpose of this study is to evaluate a questionnaire called PRO-AYA: Patient-Reported Outcomes for Adolescents and Young Adults.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 15 Years 至 39 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English- or Spanish proficient
- •o As assessed by two items: How well do you speak English? What is your preferred language for healthcare?
- •Between the ages of 15-39
- •Diagnosed with cancer or the recurrence of a cancer as per clinician report and/or received active treatment for cancer between the ages of 15-39
- •Able to complete questionnaires by themselves or with assistance as per self-report
- •For Cohort 1 ONLY:
- •3 months from last treatment without plan to initiate any form of cancer-directed treatment in the next 3 months OR
- •On chronic cancer-directed therapy for the last 3 months without plan to change cancer-directed therapy in the next 3 months AND
- •ECOG Performance Status (0-4) or KPS/Lansky Score (0-100)
排除标准
- 未提供
研究组 & 干预措施
AYAs with cancer who are at least three months post treatment with no additional treatment planned
Complete via REDCap (at enrollment): PRO-AYA (PRO-AYA - Patient-Reported Outcomes for Adolescents and Young Adults), Patient-Reported ECOG PS, EORTC QLQ-C30, Demographic/Clinical Characteristics, Complete via REDCap (7-10 days later):
PRO-AYA, Patient-Reported, ECOG PS
干预措施: Patient-Reported Outcome Surveys (Other)
AYAs(Adolescents and Young Adults) who are fluent or prefer their healthcare be delivered in Spanish
Round 1 Cognitive Interviews Complete via REDCap: Spanish PRO-AYA, Demographic/Clinical Characteristic, Item modification based on patient feedback, Cohort 2b (n = 10) (AYAs who prefer healthcare delivery in Spanish) Round 2 Cognitive interviews, Complete via REDCap: Revised Spanish PRO-AYA, Demographic/Clinical Characteristics
干预措施: Spanish version of PRO-AYA and the cognitive interview (Other)
结局指标
主要结局
Test-retest reliability
时间窗: up to one month
The test-retest reliability will be based on the intraclass correlation (ICC) coefficients between the baseline and follow-up domain scores of PRO-AYA.
Linguistically validate PRO-AYA or patients who prefer their healthcare be delivered in Spanish. (Cohort 2)
时间窗: up to a month
The primary goal of these cognitive interviews is to ensure that the wording and/or phrasing of the instructions, questions and answer choices are appropriate for native Spanish-speakers. The wording and phrasing are a result of direct translation of the English version of the PRO-AYA to a Spanish version.
次要结局
未报告次要终点