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临床试验/NCT06378749
NCT06378749已完成不适用

Previvors Recharge: A Resilience Program for Cancer Previvors

Pro-Change Behavior Systems2 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2024年4月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
138
试验地点
2
主要终点
Connor Davidson Resilience Scale (CDRISC)

研究概览

简要总结

It is estimated that 1 in 279 people may be carriers of a Hereditary Cancer Syndromes (HCS), a cancer risk that is associated with germline mutations (inherited genetic mutations passed directly from a parent to a child that create a genetic predisposition to certain types of cancer). Individuals with an HCS who have never been diagnosed with cancer (Previvors) have up to an 80% lifetime risk of developing cancer and are at an increased risk of developing multiple primary cancers during their lifetime, often with onset at an early age. Previvors face multiple forms of adversity, including a multitude of annual cancer screenings and the uncertainty of not only their own health but the health of affected family members. This study will examine the acceptability and preliminary effects of PreCharge, a resilience-boosting solution specifically designed for Previvors and delivered primarily via bi-directional text messaging. PreCharge uses proven approaches to behavior change tailoring to increase resilience by promoting a positive mindset, strong social connections, and a deep sense of meaning and purpose while also proactively addressing scanxiety. Up to 150 Hereditary Cancer Previvors will be recruited for a 30-day pilot test. Participants will complete a baseline assessment, and then be provided with 30 days of access to the PreCharge program. At the end of the 30 days, they will be prompted to complete a follow-up assessment. Outcomes to be examined will include pre-post changes on the Connor Davidson Resilience Scale.

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

入选标准

  • Identified as having Hereditary Cancer Syndrome
  • Never having been diagnosed with cancer
  • Over 18 years of age
  • Living in the United States
  • English speaking
  • Having a score of 26 or below on the Connor Davidson Resilience Scale (10 Item)
  • Access to a mobile phone
  • Agree to receive text messages.

排除标准

  • 未提供

结局指标

主要结局

Connor Davidson Resilience Scale (CDRISC)

时间窗: Baseline and 1 Month

This 10-item scale assesses five factors related to resilience. Each item is rated on a 5-point scale with higher scores reflecting greater resilience. Scores range from 0-40. There are well-established norms across a variety of populations and the scale has been used as an outcome measure to evaluate a variety of different intervention programs.

次要结局

  • Acceptance and Action Questionnaire (AAQII)(Baseline and 1 Month)

研究者

发起方
Pro-Change Behavior Systems
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kerry E. Evers

Co-President and CEO, Principal Investigator

Pro-Change Behavior Systems

研究点 (2)

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