RESPECT: (REsearching Stigma in PEdiatric Cancer Tool)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 633
- 试验地点
- 6
- 主要终点
- Develop two clinical tools that can be used to identify and measure stigma as experienced by (1) pediatric oncology patients/survivors and (2) their guardians/caregivers in culturally diverse global settings.
研究概览
简要总结
Researchers want to learn more about the way stigma affects children with cancer and their caregivers. They want to develop two clinical tools to identify and measure stigma in the pediatric cancer population within culturally diverse global settings of the United States, Guatemala, and Jordan.
Primary Objectives
- Develop two clinical tools that can be used to identify and measure stigma as experienced by (1) pediatric oncology patients/survivors and (2) their guardians/caregivers in culturally diverse global settings.
- Pilot new stigma tools in geographically and culturally diverse cancer referral settings in the United States, Guatemala, and Jordan.
详细描述
There are 2 parts to this study; participants will be included in either Part 1 or Part 2, but not both.
In Part 1 of the study, investigators will conduct a systematic literature review of tools measuring stigma in healthcare at the level of the patient and survivor, or caregiver, through which they will catalog all items included in existing instruments of the study. Literature will be searched for concepts of patient self-stigma and scales, instruments, measurements, or outcomes.
Once the search strategy is completed, a panel of experts will review items and domains sorts to remove confusing or duplicative items and produce final pilot tools containing patient-centered and clinically relevant items. Preliminary tools will be translated into Spanish and Arabic. The preliminary English tools will be professionally translated into Spanish and Arabic. Translated tools will be reviewed by international study teams as well as bilingual members of the St. Jude team to account for regional linguistic differences. The Spanish and Arabic tools will be back translated into English to ensure original intent is maintained. Any modifications needed to ensure language consistency across versions will be made in all languages, ensuring parallel versions of the tool are developed.
We will recruit up to 20 active patients and/or survivor participants aged 8-17.9 in each language (up to 60 total patient/survivor participants), and similar numbers of parents or caregivers (not recruited as dyads) and ask questions about stigma. Experienced interviewers trained by the St. Jude team will verbally administer the tool followed by probing questions to assess face validity and rate each item on a scale of 1-5 based on accuracy, clarity, and difficulty of content. After 3-4 participants have been interviewed in each language, all three tools will be reassessed with modifications made as necessary. This process will be repeated until no additional modifications are identified through interviews.
In Part 2 of the study, children who have or had cancer and their caregivers will test out the questionnaire that was created during Part 1 of the study. Investigators will recruit 225-600 active patients or survivor participants (75-200 in each language) and 225-600 parents or caregivers (75-200 in each language) to pilot the tools.
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
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cognitive Debriefing and Pilot Data Collection - Patients/Survivors
- •Age 8 to 17.9 years of age
- •Active cancer patients or survivors of cancer
- •Cognitive Debriefing and Pilot Data Collection - Parent/Caregivers
- •Adult parents or caregivers (≥ 18 years of age) of active cancer patients or survivors of cancer.
排除标准
- 未提供
研究组 & 干预措施
Pediatric oncology patients/survivors
Children who have or had cancer
Guardians/caregivers of pediatric oncology patients/survivors
Parents or caregivers of children who have or had cancer
结局指标
主要结局
Develop two clinical tools that can be used to identify and measure stigma as experienced by (1) pediatric oncology patients/survivors and (2) their guardians/caregivers in culturally diverse global settings.
时间窗: Up to 2 months after the start of study
Concept mapping, a mixed-methods approach, combining qualitative group brainstorming and sorting with descriptive statistical analysis will be utilized to describe ideas and represent them graphically. Content expert participants, including members of the research team and global healthcare professionals, will generate novel items by answering prompts. Participants will sort the items into distinctive themes and conduct cluster analyses to create an initial concept map that improves understanding of stigma domains and will be asked to rate the importance and feasibility of each item. A panel of experts will review the item and domain sorts and ratings to remove confusing or duplicative items and produce final pilot tools containing patient-centered and clinically relevant items. Pragmatic design principles will be used to make the tools short and easy to use in a variety of settings.
Pilot new stigma tools in geographically and culturally diverse cancer referral settings.
时间窗: Approximately one year after the start of study
Pilot data will be analyzed using R. Data will be descriptively analyzed before psychometric analysis focusing on item- and domain-level characteristics, including inter-item correlation and scale internal consistency (Cronbach's alpha). Confirmatory factor analysis will test the structural validity (i.e., dimensionality) of the tools. The tools will be refined by dropping items, changing domains, or editing language. The analyses will highlight items that have poor fit and the expert team will review these items and make relevant updates to the overall measure based on these analyses and feedback regarding usability. This will result in a final version of the tools in all three languages.
次要结局
未报告次要终点