A Pilot Intervention to Address Fear of Recurrence in Breast Cancer Survivors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Fear of cancer recurrence
研究概览
简要总结
The primary objective of this pilot study is to examine the feasibility and acceptability of a randomized, controlled study of a mindfulness and values-based living intervention targeted at reducing fear of recurrence in breast cancer survivors compared to treatment as usual control. Furthermore, the secondary objective of this randomized, controlled pilot study is to determine preliminary efficacy and effect size of the mindfulness and values-based living intervention compared to the treatment as usual control condition in reducing fear of recurrence in breast cancer survivors.
详细描述
Fear of cancer recurrence (FCR) is pervasive, distressing and undermines quality of life in cancer survivors. For subgroups of survivors, FCR is implicated in both treatment non-adherence and medical over-utilization. Although some degree of FCR is nearly universal among cancer patients, effective psychological interventions have been understudied. Educational and cognitive approaches that have relied on reassurance may feed into the anxiety by encouraging experiential avoidance, according to behavioral theories of anxiety. Mindfulness and values based living approaches teach techniques for reducing experiential avoidance allowing patients to break this cycle and focus on functional, satisfying lives. Interventions based on these techniques offer promise for addressing FCR in breast cancer survivors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with early stage breast cancer within the past 18 months;
- •Completed active treatment within the past year
- •At least mild anxiety, and/or at least moderate fear of recurrence as measured by screening questionnaires.
- •Ability to give written informed consent and willingness to comply with the requirements of the protocol
排除标准
- •Presence of clinically significant cognitive impairment, or comorbid psychiatric or physical illness, only if, in the PI's or Co-Is' opinions, such illness would interfere with the ability to participate in and complete the intervention;
- •Inability to speak and comprehend English sufficiently to complete the intervention.
- •We will use a screening questionnaire (administered over the phone by the Research Associate) to determine that women do not have a comorbid physical or mental illness that is so impairing that they would be unable to participate in the groups or complete the measures.
结局指标
主要结局
Fear of cancer recurrence
时间窗: Weeks 0, 6, 10, 30
Multi-dimensional fear of recurrence measure.
次要结局
- Anxiety(Weeks 0, 6, 10, 30)