Mind Body Program for Fear of Recurrence

赞助:

合作者:

信息的提供 (责任方):

Gloria Y. Yeh，Beth Israel Deaconess Medical Center

追踪信息

首次提交日期 ^ICMJE

October 2, 2018

首次发布日期e ^ICMJE

October 4, 2018

最后更新发布日期

October 4, 2018

预计研究开始日期 ^ICMJE

August 9, 2017

预计主要完成日期

June 30, 2019 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Feasibility[ Time Frame: 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.

Acceptability[ Time Frame: 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.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Fear of Cancer Recurrence[ Time Frame: Baseline, 8 weeks (Post-intervention), 1 month follow-up, 3 months follow-up ]
Fear of Cancer Recurrence Inventory. Validated self-report measure of fear of cancer recurrence. 42 items across 7 subscales (triggers, severity, psychological distress, coping strategies, functioning impairments, insight, and reassurance). Higher scores indicate more fear of recurrence. Severity subscale score ≥13 indicates clinically-elevated FCR.

描述性信息

简略标题 ^ICMJE

Mind Body Program for Fear of Recurrence

正式标题 ^ICMJE

Mind Body Program for Fear of Recurrence

简要概况

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.

详细说明

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配:
干预模型: Single Group Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Other

适用条件 ^ICMJE

干预项目 ^ICMJE

Behavioral: Mind-Body Program for Fear of Recurrence
An adapted protocol of the Relaxation Response Resiliency Program, a manualized, group-based, multimodal mind body program. Protocol adaptation includes refinement of content and study procedures to target fear of cancer recurrence (FCR) among adult cancer survivors.

研究工具

Experimental: Mind-Body Group Intervention

招募信息

招募状态 ^ICMJE

Recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

April 14, 2020

预计主要完成日期

June 30, 2019 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: 1. Patients must have a history of breast, lung, colorectal, hematologic, prostate, melanoma, or gynecological cancer (by medical record and/or self-report) 2. Completion of primary cancer treatment (radiation, surgery, and/or chemotherapy) between 3 to 30 months ago 3. Ages 18 and older (by medical record and/or self-report) Exclusion Criteria: 1. Self-reported inability to speak and write in English 2. Concurrent participation in weekly, group-based psychosocial or mind-body programs 3. 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. 4. Inability to travel to necessary study visits 5. No e-mail address to access online assessments

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

United States

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

Gloria Y. Yeh，Beth Israel Deaconess Medical Center

研究赞助商 ^ICMJE

Beth Israel Deaconess Medical Center

合作者 ^ICMJE

研究员 ^ICMJE

PRS 账户

Beth Israel Deaconess Medical Center

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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