IN FOCUS: A Multimodal Mind-Body Intervention for Fear of Recurrence Among Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 10
- 主要终点
- Acceptability: 5 Item Measure of Enjoyableness, Convenience, Helpfulness, Odds of Future Use, and Overall Satisfaction
研究概览
简要总结
The purpose of this study is to test the feasibility of a virtual, group mind-body resiliency intervention adapted to target fear of recurrence (FOR) among cancer survivors.
详细描述
This is a randomized pilot feasibility trial (1:1 intervention versus usual care; a referral to community-based cancer survivor support group) that will use mixed methods (quantitative and qualitative) to evaluate the feasibility, acceptability, and preliminary effects of a virtual, group mind-body resiliency intervention adapted to target fear of recurrence (IN FOCUS) among cancer survivors with clinically elevated fear of recurrence (N = approximately 64).
Patient-reported outcomes on psychological and behavioral outcomes will be measured at T0 (baseline), T1 (post-intervention/approximately two months post-baseline), and T2 (three months post-intervention/approximately five months post-baseline). Exit interviews will be conducted after the T1 survey. Participants are expected to be in the study for approximately five months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
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
- •History of non-metastatic, localized, or regional solid or blood malignancy(ies)
- •Completion of primary cancer treatment (i.e., radiation, surgery, chemotherapy) and/or current use of long-term maintenance hormonal or biologic therapy
- •Age ≥18 years
- •Elevated fear of recurrence (FCRI severity score ≥16)
- •MGB/BIDMC Medical Record Number (MRN)
排除标准
- •Self-reported inability to speak and write in English
- •Undertreated serious mental illness as defined by history of suicidality, psychosis, and/or psychiatric hospitalization in the past year
- •Inability to access technology and/or sufficient internet to participate virtual groups sessions
结局指标
主要结局
Acceptability: 5 Item Measure of Enjoyableness, Convenience, Helpfulness, Odds of Future Use, and Overall Satisfaction
时间窗: Baseline to approximately 2 months
As a primary quantitative acceptability outcome, participants will be asked to rate the enjoyableness, convenience, helpfulness, odds of future use, and overall satisfaction (1=very low to 5=very high) of the intervention.
Feasibility: Retention Rate
时间窗: Baseline to approximately 2 months
The primary metric for assessing feasibility will be retention at the initial follow-up assessment (≥70% survey completion). For descriptive purposes, secondary exploratory metrics of feasibility will include reasons for ineligibility, refusal, or dropping out will be measured, as will rates of enrollment, ratio of screened-to-eligible, attendance (e.g., ≥75% of intervention sessions attended), self-reported adherence to relaxation skills practice, and interventionist fidelity. Exit interviews will use open-ended questions to assess the feasibility of attending virtual sessions.
次要结局
- Resiliency(Baseline, approximately 2 months, approximately 5 months)
- Fear of Cancer Recurrence(Baseline, approximately 2 months, approximately 5 months)
研究者
Daniel Hall
Principal Investigator
Massachusetts General Hospital