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临床试验/NCT04927013
NCT04927013已完成不适用

Testing a Low Cost Population- and Theory-Based Outreach Intervention to Engage Ovarian Cancer Survivors and Their Close Relatives to Consider Genetic Services

Emory University2 个研究点 分布在 1 个国家目标入组 2,331 人开始时间: 2021年7月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,331
试验地点
2
主要终点
Number of Survivors Using Website Access Code

研究概览

简要总结

This study tests a multi-component, low cost, message-based communication outreach intervention to engage ovarian cancer survivors and their at-risk relatives in considering cancer genetic services. The intervention includes foot-in-the-door techniques, tailored/targeted print, website support, and short messages to expand reach of prevention messages.

详细描述

The majority of women at greatest risk for ovarian cancer due to hereditary factors are unlikely to be aware of their elevated risk and available prevention options. Thus, most at-risk women are diagnosed when their ovarian cancer is advanced and treatment options are limited. Additionally, efforts to broaden awareness of genetic risk among at risk families has been very limited. State cancer registries' offer a potentially low cost platform for providing resources to ovarian cancer survivors and their close relatives.

In partnership with the Georgia Cancer Registry (GCR), the researchers are testing two different communication approaches to provide inherited risk information and free genetic counseling to ovarian cancer survivors and their close blood relatives. Participants will be assigned at random to visit one of two websites; those assigned to the "message-based" site will be offered assistance from the study team to contact close relatives and reminder messages and those viewing the other site will not. The researchers are testing which of the two approaches is most effective as indicated by: the number of survivors who visit the website; the number of close relatives who visit the website and the number of survivors and relatives who complete a genetic counseling session. The researchers hypothesize that the message-based approach will result in greater reach and uptake of genetic services than a standard approach.

The two outreach websites with content for both survivors and close relatives will be the hub in the wheel of intervention activity. In turn, the researchers will encourage access to the website using other communication channels as the spokes. The GCR will make initial contact with ovarian cancer survivors. The Registry will: 1) mail a packet of information about the study to identified survivors, and 2) make follow-up phone calls and send reminder postcards to encourage study participation. Survivors can then visit the assigned website and click a button indicating they agree to participate. Survivors assigned to the message-based intervention will receive additional short text messages encouraging them to contact relatives and seek genetic counseling. Relatives in this message-based group who choose to participate will also receive these short messages if they choose to provide contact information.

Free genetic counseling is being offered to participants in both study arms. The researchers are collaborating with Emory's Genetic Counseling Training program under the supervision of two certified genetic counselors. This study uses tele-medicine approaches to ensure access of survivors and relatives living in Georgia and elsewhere.

The results of the study could guide the development of outreach strategies for Georgia and other states to offer sustainable services to expand the reach of genetic services for ovarian and other heritable cancers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Number of Survivors Using Website Access Code

时间窗: Up to 19 months

Survivor reach is assessed as the number of the eligible survivors identified and contacted by GCR who used their unique login to access the study website.

Number of Survivors Consenting to Participate in the Study

时间窗: Up to 19 months

Survivor reach is assessed as the number of the eligible survivors identified and contacted by GCR who used their unique login code to access the study website and consented to participate in the study while visiting the website.

Number of Survivors Creating a Study Login

时间窗: Up to 19 months

Survivor reach is assessed as the number of the eligible survivors identified and contacted by GCR who access the study website, consented to participate in the study, and created their own personal study login on the website.

Number of Relatives of Survivors Using the Website Access Code

时间窗: Up to 19 months

Close relative reach is assessed as the number of close relatives enumerated by survivors who used their unique login code to access the study website.

Number of Relatives of Survivors Consenting to Participate in the Study

时间窗: Up to 19 months

Close relative reach is assessed as the number of close relatives enumerated by survivors who accessed the website and consented to participate in the study while they were using the website.

Number of Relatives of Survivors Creating a Login

时间窗: Up to 19 months

Close relative reach is assessed as the number of close relatives enumerated by survivors who accessed the study website, gave consent to participate in the study, and created their own personal study login on the study website.

次要结局

  • Relative Contact Option Selected by Survivors(Up to 19 months)
  • Number of Survivors Requesting Telegenetic Counseling(Up to 19 months)
  • Number of Survivors Completing Telegenetic Counseling(Up to 19 months)
  • Number of Relatives Requesting Telegenetic Counseling(Up to 19 months)
  • Number of Relatives Completing Telegenetic Counseling(Up to 19 months)
  • Time Visiting Website by Survivors(Up to 19 months)
  • Time Visiting Website by Relatives(Up to 19 months)
  • Number of Return Visits to Website by Survivors(Up to 19 months)
  • Number of Return Visits to Website by Relatives(Up to 19 months)
  • Number of Pages Viewed by Survivors(Up to 19 months)
  • Number of Pages Viewed by Relatives(Up to 19 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yue Guan

Associate Professor

Emory University

研究点 (2)

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