Optimizing Health Related Quality of Life Measurement in Adolescent and Young Adult Oncology: A Promising Solution (PROMIS AYA) - Aim 2
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 2
- 主要终点
- Refining of Item Pools - Development of Four Item Banks
研究概览
简要总结
This study evaluates how adolescent and young adults with cancer in the U.S. and their loved ones respond to questions that will later be used with people who may have cancer and other chronic health conditions
详细描述
PRIMARY OBJECTIVES:
- To refine patient-reported outcome assessment tools of body image, fertility, and financial burden for PROMIS and evaluate assumptions for IRT consistent with PROMIS Scientific Standards (e.g., unidimensionality, local independence).
- To examine item-level properties to support computer adaptive testing and evaluate possible differential item functioning (DIF).
Secondary Objective
- To create short forms and examine convergent validity of the new body image, fertility, and financial burden short forms and item banks with corresponding legacy measures of those constructs.
OUTLINE: This is an observational study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •AYAs with a cancer history (AYA-C)
- •Inclusion Criteria:
- •Young adults between the ages of 15 to 39 years;
- •First diagnosed with cancer during 15 to 39 years of age;
- •Able to read and understand English;
- •Live in the United States;
- •Have a new cancer diagnosis and are receiving curative treatment OR are currently 0 to 10 years post-treatment.
排除标准
- •Diagnosed with basal cell skin cancer; or
- •Are currently receiving hospice care.
- •AYAs General Population (AYA-GP)
- •Inclusion Criteria:
- •Young adults between the ages of 15 to 39 years;
- •Able to read and understand English; and
- •Live in the United States.
- •Caregivers of AYAs with cancer (AYA-Cg)
- •Inclusion Criteria:
- •18 years of age or older;
- •Able to read and understand English;
- •Live in the United States;
- •Have a child/ward/partner for whom they have provided care, AND
- •Their child/ward/partner is 15 to 25 years of age and meets the other eligibility criteria as an AYA participant with a cancer history (described above).
研究组 & 干预措施
Observational
Participants will complete self-report questionnaires via Redcap. The questionnaires should take less than 30 minutes
干预措施: Surveys/Questionnaires (Other)
结局指标
主要结局
Refining of Item Pools - Development of Four Item Banks
时间窗: Up to study completion, up to approximately 2 years
Upon completion of data analysis and study team review, investigators will have four unidimensional and locally independent, calibrated item banks: three for AYAs (body image, fertility, and financial burden) and one for caregivers (financial burden). In order to successfully calibrate an item bank, an n=500 is required per bank. In order to examine differential item functioning (DIF), a minimum n=200 per group is recommended. Our proposed sample sizes and specific subgroup accrual targets will be needed to calibrate multiple new item banks (body image, fertility, financial burden), evaluate DIF for various categories (age, gender, race, education) within our sample subgroups (AYAs with and without cancer), and to conduct confirmatory factor analysis (CFAs) on the item banks. In addition, the AYA sample the general population will serve as our reference to establish the mean and standard deviation for body image and fertility.
次要结局
- Short Form Development Based on Item Bank Data(Up to study completion, up to approximately 2 years)