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临床试验/NCT05952492
NCT05952492已完成不适用

Improving Young Adult Cancer Survivors' Mental Health with an EHealth Group Intervention

University of Arizona2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年1月16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
32
试验地点
2
主要终点
Feasibility of recruitment of young adult cancer survivors

研究概览

简要总结

The purpose of this study is to determine the feasibility of recruiting young adult cancer survivors from across the nation and to explore the impact of an eHealth group intervention on psychosocial health in this population.

详细描述

Study investigators will conduct a single-arm pilot trial in which a 10 week eHealth group intervention will be delivered via a study website. We will use a multi-pronged approach to recruit young adult cancer survivors from across the country. Study participants will attend weekly group meetings with a trained facilitator to receive the manualized intervention over the course of 10 weeks.

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 39 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18-39 years at the time of participation
  • Diagnosed with any invasive cancer between 15-39 years old
  • Finished curative cancer treatment 1 month to 5 years prior to enrollment (except maintenance therapy such as ongoing hormone therapy)
  • Currently experiencing at least mild symptoms of depression or anxiety (i.e., score ≥1 on the Patient Health Questionnaire-4)
  • Able to speak and read English so all group attendees can communicate in a shared language.
  • Able and willing to give informed consent.
  • Access to internet or cellular connectivity with sufficient bandwidth to participate in videoconferences

排除标准

  • Documented or observable psychiatric or neurological disorders that could interfere with study participation (e.g., psychosis, active substance abuse)

结局指标

主要结局

Feasibility of recruitment of young adult cancer survivors

时间窗: Through study completion, an average of 1 year

Recruitment will be considered feasible if ≥40% of eligible survivors enroll in the study.

次要结局

  • Change in health-related quality of life from baseline to immediately after the intervention(Baseline and immediately after the intervention)
  • Change in stress management self-efficacy skills from baseline to immediately after the intervention(Baseline and immediately after the intervention)
  • Change in cancer-related distress from baseline to immediately after the intervention(Baseline and immediately after the intervention)
  • Change in coping from baseline to immediately after the intervention(Baseline and immediately after the intervention)
  • Change in anxiety symptoms from baseline to immediately after the intervention(Baseline and immediately after the intervention.)
  • Change in depression symptoms from baseline to immediately after the intervention(Baseline and immediately after the intervention.)
  • Change in trend and relative values of time and frequency domain heart rate variability metrics from pre- to post-intervention.(Baseline and the final week of the intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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