Identification of Anxiety and Depression in Adolescents/Young Adults (AYA) With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Feasibility of a multi-site, multiple time-point psychosocial study for AYA with cancer
研究概览
简要总结
This is a prospective, multisite (but all within the UTSW IRB), observational study assessing the relationship of hope to anxiety and depression, QoL, and social support over time in the first year after cancer diagnosis or relapse in AYA (ages 15-29 years of age).
详细描述
The principal investigators' ongoing work suggests hope is a target for intervention to improve quality of life (QoL) and reduce anxiety and depression (A/D) among adolescents/young adults (AYA). No study to the investigators' knowledge has evaluated the promising impact of hope interventions in AYA cancer patients. To address this gap, the investigators will expand the investigators' prior research on hope, A/D, and QoL to AYA receiving care across three diverse healthcare systems.
Patients will be approached for participation within 3 months of their initial/relapse cancer diagnosis. Eligible patients (and the parent/caregiver for minor patients) will be approached in a private area of the clinic or hospital room to explain the research aims and informed consent process. After obtaining informed consent/assent (from parents if patients are under 18, from AYA if patient is 18 or older), participants (patients) will utilize an iPad to complete measures via Redcap.
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
- 15 Years 至 29 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents and young adults (15-17, 18-29 years of age, respectively) with a new or relapse diagnosis of a malignancy
- •Patients will include those being followed (treatment or observational) for any malignant disorder at Children's Medical Center, UT Southwestern Medical Center, or Parkland Health and Hospital Systems
- •Patients whose native language is Spanish or English are eligible to participate
- •Patients may have any life expectancy
- •Ability to understand and the willingness to sign a written informed consent.
排除标准
- •Patients with clinically apparent cognitive disabilities which would preclude understanding and completion of measures.
- •Patients with significant medical issues such as delirium which preclude their ability to consent and complete initial measures
结局指标
主要结局
Feasibility of a multi-site, multiple time-point psychosocial study for AYA with cancer
时间窗: up to 12 months (+/- one 4 weeks) following enrollment
* Hypothesis a: Greater than 50% of eligible patients will enroll and complete at least two time points in the study. * Hypothesis b: Enrollment and study completion rates will differ by site, with the site with the most psychosocial risk (low socioeconomic status as measured by insurance type (private, public, uninsured)) having the lowest enrollment and study completion rates. * Hypothesis c: Enrollment and study completion rates will differ by treatment type. Those receiving treatment that has the most frequent clinic/hospital visits (as measured by chemotherapy versus radiation only/surgery only) will have the highest completion rates.
次要结局
- Determine the impact of medical factors (treatment) on QoL in AYA with cancer(up to 12 months (+/- one 4 weeks) following enrollment)
- Determine the impact of socieconomic status on QOL in AYA with cancer(up to 12 months (+/- one 4 weeks) following enrollment)
- Determine the impact of medical factors (treatment) on hope in AYA with cancer(up to 12 months (+/- one 4 weeks) following enrollment)
- Correlation between hope and quality of life (QoL) in AYA cancer patients(up to 12 months (+/- one 4 weeks) following enrollment)
- Correlation between hope and anxiety and depression (A/D) in AYA cancer patients(up to 12 months (+/- one 4 weeks) following enrollment)
- Determine the impact of medical factors (treatment) on AD in AYA with cancer(up to 12 months (+/- one 4 weeks) following enrollment)
- Determine the impact of socieconomic status on AD in AYA with cancer(up to 12 months (+/- one 4 weeks) following enrollment)
- Correlation between hope and social support (SS) in AYA cancer patients(up to 12 months (+/- one 4 weeks) following enrollment)
- Determine the impact sex on SS in AYA with cancer(up to 12 months (+/- one 4 weeks) following enrollment)
- Determine the impact of age on SS in AYA with cancer(up to 12 months (+/- one 4 weeks) following enrollment)
- Determine the impact of socieconomic status on hope in AYA with cancer(up to 12 months (+/- one 4 weeks) following enrollment)
- Determine the impact of medical factors (treatment) on SS in AYA with cancer(up to 12 months (+/- one 4 weeks) following enrollment)
- Determine the impact sex on hope in AYA with cancer(up to 12 months (+/- one 4 weeks) following enrollment)
- Determine the impact sex on QoL in AYA with cancer(up to 12 months (+/- one 4 weeks) following enrollment)
- Determine the impact sex on AD in AYA with cancer(up to 12 months (+/- one 4 weeks) following enrollment)
- Determine the impact of age on QoL in AYA with cancer(up to 12 months (+/- one 4 weeks) following enrollment)
- Determine the impact of age on hope in AYA with cancer(up to 12 months (+/- one 4 weeks) following enrollment)
- Determine the impact of age on AD in AYA with cancer(up to 12 months (+/- one 4 weeks) following enrollment)
- Determine the impact of socieconomic status on SS in AYA with cancer(up to 12 months (+/- one 4 weeks) following enrollment)
研究者
Julie Germann
Associate Professor of Psychiatry
University of Texas Southwestern Medical Center