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临床试验/NCT03695406
NCT03695406已完成不适用

Mind Body Program for Fear of Recurrence

Beth Israel Deaconess Medical Center1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2017年8月9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
23
试验地点
1
主要终点
Acceptability

研究概览

简要总结

This is a pilot feasibility study of a group-based, mind body intervention for managing stress and fear of recurrence and promoting resiliency among adult cancer survivors.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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
否

入选标准

  • •Patients must have a history of breast, lung, colorectal, hematologic, prostate, melanoma, or gynecological cancer (by medical record and/or self-report)
  • •Completion of primary cancer treatment (radiation, surgery, and/or chemotherapy) between 3 to 30 months ago
  • •Ages 18 and older (by medical record and/or self-report)

排除标准

  • •Self-reported inability to speak and write in English
  • •Concurrent participation in weekly, group-based psychosocial or mind-body programs
  • •Serious mental illness (by medical record and/or self-report) as defined by history of suicidality, psychosis, and/or psychiatric hospitalization in the past year.
  • •Inability to travel to necessary study visits
  • •No e-mail address to access online assessments

研究组 & 干预措施

Mind-Body Group Intervention

Experimental

干预措施: Mind-Body Program for Fear of Recurrence (Behavioral)

结局指标

主要结局

Acceptability

时间窗: During intervention group sessions (approximately 2 months)

The primary metric for assessing Acceptability will be a five-item, investigator developed self-report questionnaire. Following each study session, participants will be asked to rate (1=not at all to 5=very much) the enjoyableness, convenience, helpfulness, relevancy, odds of future use, and overall satisfaction of the session.

Feasibility (i.e., retention at initial follow-up assessment)

时间窗: Through study completion (approximately 5 months)

The primary metric for assessing Feasibility will be retention at the initial follow-up assessment. Reasons for ineligibility, refusal, or dropping out will be measured.

次要结局

  • Fear of Cancer Recurrence(Baseline, 8 weeks (Post-intervention), 1 month follow-up, 3 months follow-up)

研究者

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

Gloria Y. Yeh

Associate Professor of Medicine

Beth Israel Deaconess Medical Center

研究点 (1)

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