Kindness to Others or to Oneself: A Pilot Randomized Controlled Trial of Kindness Interventions to Enhance Well-Being in Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 4
- 主要终点
- Depressive symptoms (Center for Epidemiologic Studies Depression Scale)
研究概览
简要总结
Emerging evidence suggests that both extending kindness towards others and self-kindness practices may have beneficial effects on well-being. This randomized pilot clinical trial will investigate the efficacy of two kindness interventions -acts of kindness (to self or to other) and loving-kindness meditation- for use with early-stage breast cancer survivors.
详细描述
PRIMARY OBJECTIVES:
I. To refine two interventions - loving kindness and acts of kindness- for use with breast cancer survivors using an online platform.
II. To determine the feasibility and preliminary efficacy of these interventions on positive affect, depressive symptoms, and other aspects of well-being among women with breast cancer.
OUTLINE: Participants are randomized to 1 of 4 groups.
GROUP I (ACTS OF KINDNESS TO OTHERS): Participants perform small acts of kindness or generosity for others 3 times per week for 4 weeks and complete weekly online questionnaires.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women previously diagnosed with stage 0-IIIA breast cancer
- •Have completed treatment with surgery, radiation, and/or chemotherapy
- •Have not had a cancer recurrence
- •Have access to the internet and an active email account
排除标准
- 未提供
结局指标
主要结局
Depressive symptoms (Center for Epidemiologic Studies Depression Scale)
时间窗: Up to 2 years
Analyses will be conducted under the intent-to-treat principle, including all participants in their assigned condition, accomplished by fitting models to all available data for each outcome measure, including data of participants with incomplete follow-up. Linear mixed models provide valid inferences under a missing at random assumption. Differences between conditions in change over time will be examined by testing condition-by-time interaction terms. Analyses will control for any participant characteristics with baseline imbalance among conditions or that differ between participants retained. Depressive symptoms will be measured at baseline and post-intervention using the 20-item Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is a measure of symptom severity across the previous week, and total scores range from 0 to 60. Higher scores indicate greater severity of depressive symptoms.
Psychological well-being measured by the Mental Health Continuum-Short Form
时间窗: Up to 2 years
Analyses will be conducted under the intent-to-treat principle, accomplished by fitting models to all available data for each outcome measure, including data of participants with incomplete follow-up. Analyses will control for any participant characteristics with baseline imbalance among conditions or that differ between participants retained. Psychological well-being measured by the Mental Health Continuum-Short Form (MHC-SF) Well-being will be measured at both baseline and post-intervention via the 14-item MHC-SF. Total scores range from 0 to 70, with higher scores indicating greater overall well-being. The MHC-SF is comprised of three empirically derived subscales: the 3-item Emotional Well-Being Subscale (score range: 0 to 15), the 6-item Psychological Well-Being Subscale (score range: 0 to 30), and the 5-item Social Well-Being Subscale (score range: 0 to 25). Higher scores on each subscale indicate greater well-being within that domain.
次要结局
- Fulfillment of psychological needs measured by the Balanced Measure of Psychological Needs(Up to 2 years)
- Pain measured by the Pain Subscale of the Rand Health 36-item Short Form Survey(Up to 2 years)
- Life satisfaction measured by the Satisfaction with Life Scale(Up to 2 years)
- Self-kindness measured by the Self-Compassion Scale(Up to 2 years)
- Big-5 Personality Dimensions measured by the Ten-Item Personality Inventory (TIPI)(Baseline)
- Empathy measured by the Perspective Taking & Empathic Concern Subscales of the Interpersonal Reactivity Index(Up to 2 years)
- Positive and negative affect measured by the Affect-Adjective Scale(Up to 2 years)
- Qualitative assessment of acts performed(Up to 2 years)
- Social connection measured by the Attachment Subscale of the Social Provisions Scale(Up to 2 years)
- Fatigue measured by the Severity items of the Fatigue Symptom Inventory(Up to 2 years)
- Sleep disturbance measured by the Patient-Reported Outcomes Measurement Information System Sleep Disturbance Scale(Up to 2 years)
- Social support measured by the 2-way Social Support Scale(Up to 2 years)