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临床试验/NCT05472714
NCT05472714已完成不适用

Integration of Multimodal Cancer Predisposition Genetic Counseling Practices Within the Pediatric Oncology Setting: Video Intervention for Newly Diagnosed Families Undergoing Genetic Testing

Children's Hospital of Philadelphia2 个研究点 分布在 1 个国家目标入组 359 人开始时间: 2021年9月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
359
试验地点
2
主要终点
Knowledge Score - Before Results

研究概览

简要总结

Develop and evaluate the acceptability, feasibility, and preliminary efficacy of an informational video on paired tumor/normal testing for children and adolescents with a new diagnosis of cancer, tumors or other diagnosis.

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 establishing best practices to optimize delivery of care for patients undergoing testing and their families. Tumor/normal genetic testing (testing of both tumor tissue and a paired normal sample) at time of cancer diagnosis or relapse is now widespread in pediatric oncology to improve cancer diagnostics, prognostics, and treatment; this testing also has potential to uncover underlying cancer predisposition syndromes with lifelong implications. Disseminating information at the time of cancer diagnosis is difficult, and is best done by a provider with expertise in cancer genetics. Thus, Investigators will develop an informational video for use prior to tumor/normal genetic testing to augment genetic counseling resources to support patients and families.

In this study, Investigators will develop and evaluate the acceptability, feasibility, and preliminary efficacy of an informational video on paired tumor/normal testing for children and adolescents with a new diagnosis of cancer, tumors or other diagnosis. Investigators will use a non randomized trial whereby a convenience sample of patients/families will be recruited to be controls in Year 1, followed by a convenience sample that will be allocated the video intervention In Year 2. To evaluate the impact of the video intervention, Investigators will compare assessments of two cohorts- an unexposed (no video intervention, Year 1) and exposed (video intervention, Year 2).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
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

入选标准

  • Parent or Legal Guardian of a patient with a new diagnosis of cancer, tumor, or other diagnosis referred for tumor/normal sequencing (proband) in the Cancer Center at the Children's Hospital of Philadelphia (CHOP)
  • Able to be approached within 1-4 weeks of tumor/normal sequencing
  • Appropriate to approach per oncology team
  • No cognitive impairment limiting ability to complete measures
  • Ability to read and speak English fluently
  • Adolescent/Young Adult (AYA) probands
  • Child proband receiving germline testing in the Cancer Center at CHOP
  • Able to be approached within 1-4 weeks of tumor/normal sequencing
  • Appropriate to approach per oncology team
  • No cognitive impairment limiting ability to complete measures
  • Ability to read and speak English fluently

排除标准

  • 1) Not meeting any of inclusion criteria.

研究组 & 干预措施

Without Video

No Intervention

In year 1, investigators will recruit families of patients receiving the current standard-of-care approach to tumor-normal genetic testing with provider based education.

With Video

Experimental

In year 2, investigators will recruit families of patients receiving the updated standard-of-care approach to tumor-normal genetic testing with provider based education and an educational video.

干预措施: Educational Video (Other)

结局指标

主要结局

Knowledge Score - Before Results

时间窗: up to 4 weeks after testing

The primary outcome is the primary caregiver's knowledge score measured before receipt of genetic results. Knowledge score is a 12-point true/false questionnaire. Higher scores indicate higher genetic knowledge.

Percentage of Correct Items on Knowledge Questionnaire - Before Results

时间窗: Up to 4 weeks after testing

The primary outcome is the percentage of correct items on a genetic knowledge survey that was developed for this study, measured at baseline and before receipt of genetic test results. Participants evaluated included the primary caregivers, secondary caregivers and probands aged 12+. Total scores were generated by summarizing total number of correct responses and generating a percentage. The Genetic Knowledge measure included 12 true/false questions. Higher scores indicate higher genetic knowledge.

次要结局

  • Knowledge Score - all caregivers and probands(Twice, prior to, and within 6 months after receipt of results)
  • Acceptability of use of an informational video on paired tumor/normal testing for participants with a new cancer or other diagnosis(One time, within 6 months after receipt of results)
  • Knowledge Score - After Results(Once, within 6 months after receipt of results)
  • Feasibility of an informational video on paired tumor/normal testing for children and adolescents with a new cancer diagnosis.(One time, within 6 months after receipt of results)
  • Percentage of Correct Items on Knowledge Questionnaire - After Results(Up to 6 months post-genetic test result)
  • Acceptability of Use of an Informational Video on Paired Tumor/Normal Testing for Participants With a New Cancer or Other Diagnosis(One time, within 6 months after receipt of results)
  • Intervention Feasibility - Technical Error(One time, within 6 months after receipt of results)
  • Intervention Feasibility - Days to Receive Intervention(One time, within 6 months after receipt of results)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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