Integration of Multimodal Cancer Predisposition Genetic Counseling Practices Within the Pediatric Oncology Setting: Digital Care Plans for Patients With CPS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 177
- 试验地点
- 2
- 主要终点
- Change in Knowledge Score
研究概览
简要总结
Develop and evaluate acceptability, feasibility, and preliminary efficacy of digital care plan and accompanying text message reminders for children and adolescents with a known Cancer Predisposition Syndromes (CPS).
详细描述
As over 15% of pediatric cancers are associated with a cancer predisposition, it is increasingly becoming standard of care for children with cancer, as well as those with suspected hereditary risk, to be evaluated for germline cancer predisposition. Unfortunately, the increase in pediatric genetic testing has exceeded the pace of research supporting effective cancer surveillance in positive cases. Additionally, guidelines for cancer predisposition management are not easily accessed or understood by families; thus, there is often a disconnect between the understanding and retention of such information relayed to families.
In this study, Investigators will develop and evaluate the acceptability, feasibility, and preliminary efficacy of digital care plans for Cancer Predisposition Syndromes (CPS) with accompanying text message reminders for children and adolescents with a known CPS. Digital care plans and text messages will be created for 10 common CPS. Investigators will use a quasi-experimental design with pre and post testing of the same cohort, before and after delivery of care plan and accompanying messages. To evaluate the impact of the digital care plans, Investigators will compare assessments of the same cohorts at 3 and 6 months time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parent or Legal Guardian of a patient with a known cancer predisposition syndrome diagnosed within the last 5 years
- •Received care at the Cancer Predisposition clinic at the Children's Hospital of Philadelphia (CHOP), or other medical institutions (does not need to be receiving follow-up care at CHOP)
- •Appropriate to approach per oncology team/cancer predisposition team
- •No cognitive impairment limiting ability to complete measures
- •Ability to read and speak English fluently
- •Adolescent/Young Adult (AYA) probands
- •Child proband with a known cancer predisposition syndrome diagnosed within the last 5 years
- •Received care at the Cancer Predisposition clinic at the Children's Hospital of Philadelphia (CHOP), or other medical institutions (does not need to be receiving follow-up care at CHOP)
- •Appropriate to approach per oncology team/cancer predisposition team
- •No cognitive impairment limiting ability to complete measures
- •Ability to read and speak English fluently
排除标准
- •Not meeting any of inclusion criteria
研究组 & 干预措施
Intervention: Digital Care Plans with Accompanying Text Messages
Investigators will recruit families and patients diagnosed with a Cancer Predisposition Syndrome within 5 years. Participants will be provided with a digital care plan and optional accompanying text message reminders.
干预措施: Digital Care Plans (Other)
结局指标
主要结局
Change in Knowledge Score
时间窗: 3 months and 6 months after receipt of digital care plan
The primary outcome is the percentage of correct items on a knowledge survey that was developed for this study and administered via REDCap, measured at baseline (2 weeks prior to receiving the Care Plan/text message intervention), midpoint (3 months post receiving the Care Plan/text message intervention), and final (6 months post receiving the Care Plan/text message intervention) surveys. The change in the mean and standard deviation will be assessed at 3 months and 6 months. Participants evaluated included the caregivers and AYAs aged 12-26. Total scores were generated by summarizing total number of correct responses and generating a percentage. The knowledge measure included a mix of 10-12 multiple choice and true/false questions, CPS dependent. Higher scores indicate higher CPS knowledge and Care Plan content.
次要结局
- Acceptability of Use of Digital Care Plans for CPS(3 Months After Receipt of Digital Care Plan)
- Feasibility of Use of Digital Care Plans for CPS for Patients Diagnosed Within 5 Years(Up to 6 months after receipt of digital care plan)
- Satisfaction With Decision (SDS) to Have Germline Testing(Up to 6 months after receipt of digital care plan)
- Change in Cancer-Related Anxiety(Up to 6 months after receipt of digital care plan)