Adapting and Testing a Novel Self-Compassion Intervention to Reduce Lung Cancer Stigma
概览
- 阶段
- 不适用
- 干预措施
- Mindful Self-Compassion for Lung Cancer (MSC-LC)
- 疾病 / 适应症
- Lung Cancer
- 发起方
- Loyola Marymount University
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Lung Cancer Stigma Inventory
- 状态
- 已完成
- 最后更新
- 19天前
概览
简要总结
The goal of this pilot clinical trial is to test a disease-tailored, mindfulness-based intervention (Mindful Self-Compassion for Lung Cancer; MSC-LC) in adults diagnosed with lung cancer who are experiencing stigma. The current project seeks to:
- Evaluate preliminary evidence for the feasibility, acceptability, and preliminary efficacy of MSC-LC in reducing stigma for adults with lung cancer, compared to a waitlist control condition
- Elicit interventional impact not captured through quantitative measures with qualitative data from purposively sampled high responders and non-responders from the intervention condition
Participants will randomized to either the MSC-LC intervention (a 10-week, virtually-delivered, group-based psychosocial intervention focused on the development of mindfulness and self-compassion skills) or to a waitlist control group that receives a referral to an NCI list of helpful mental health resources in their community. Researchers will compare the intervention and control groups to see if the MSC-LC intervention reduces lung cancer stigma and increases self-compassion.
详细描述
Lung cancer stigma (i.e., perceived and internalized negative appraisal and devaluation associated with lung cancer) is a pervasive problem experienced by the majority of lung cancer patients. Notably, experiences of lung cancer stigma are strongly associated with poorer quality of life and higher depressive symptoms. Despite these associations, there is a gap in the field regarding empirically supported, patient-focused interventions that target the reduction of lung cancer stigma. Self-compassion (i.e., directed kindness towards oneself in times of suffering) is a protective psychosocial factor that has been targeted through intervention approaches to reduce shame and self-criticism in non-cancer samples. Additionally, higher self-compassion has been shown to attenuate the relationship between lung cancer stigma and depression, suggesting that fostering self-compassion may be an effective intervention strategy to reduce lung cancer stigma. Mindful Self-Compassion is an empirically supported, 8-week psychosocial intervention demonstrated to increase self-compassion and reduce feelings of shame, distress, depression, and anxiety in non-cancer samples. However, given several anticipated challenges associated with delivering Mindful Self-Compassion to lung cancer patients (e.g., breathing challenges that arise during breath-focused meditations, fatigue that interferes with attending 3-hour sessions), the investigators developed an adapted version of the intervention (Mindful Self-Compassion for Lung Cancer; MSC-LC) that is tailored to the needs of adults diagnosed with lung cancer, addresses delivery challenges, and targets the reduction of lung cancer stigma. This is a pilot trial examining the feasibility, acceptability, and preliminary efficacy of MSC-LC, compared to waitlist control condition. The central hypothesis is that MSC-LC will be demonstrate high feasibility and acceptability as well as preliminary efficacy in reducing lung cancer stigma and promoting self-compassion.
研究者
Timothy Williamson
Assistant Professor
Loyola Marymount University
入排标准
入选标准
- •Is at least 18 years of age as per self report;
- •Has a confirmed lung cancer diagnosis, as per self-report and confirmed by clinician judgment or medical record note;
- •Endorses elevated levels of lung cancer stigma (scores \>37.5 on the Lung Cancer Stigma Inventory)
- •Able to read and respond to questions in English
排除标准
- •Inability to understand study procedures or informed consent process, or significant personality dysfunction likely to interfere with study participation, as per study clinician's judgment
- •Completed a course of Mindful Self-Compassion or an equivalent meditation training in the last year
- •Use of antidepressant, anxiolytic, antipsychotic, or mood stabilizing medication(s) for which the dose has been initiated or changed within the 8 weeks prior to study entry
研究组 & 干预措施
Mindful Self-Compassion for Lung Cancer (MSC-LC)
Group-based psychosocial intervention adapted from Mindful Self-Compassion that focuses on the development of mindfulness and self-compassion skills to reduce lung cancer stigma.
干预措施: Mindful Self-Compassion for Lung Cancer (MSC-LC)
Enhanced standard of care with waitlist
Control group that will receive a list of mental health resources and will complete questionnaire assessments during a parallel timeframe as participants in the intervention condition and be placed on a waiting list to receive the MSC-LC intervention after study completion.
干预措施: Enhanced standard of care with waitlist
结局指标
主要结局
Lung Cancer Stigma Inventory
时间窗: Study Entry, 5 weeks (mid-intervention), 10 weeks (post-intervention; primary outcome), 16 weeks (long-term follow-up)
The Lung Cancer Stigma Inventory is a self-report questionnaire of lung cancer stigma, which includes 25 items rated on a 5-point Likert scale. Scores range from 25-125, with higher scores indicating higher lung cancer stigma.
次要结局
- Self-Compassion Scale(Study Entry, 5 weeks (mid-intervention), 10 weeks (post-intervention), 16 weeks (long-term follow-up))
- Patient Health Questionnaire-8(Study Entry, 5 weeks (mid-intervention), 10 weeks (post-intervention), 16 weeks (long-term follow-up))
- Generalized Anxiety Disorder-7(Study Entry, 5 weeks (mid-intervention), 10 weeks (post-intervention), 16 weeks (long-term follow-up))
- Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being, meaning and peace subscales(Study Entry, 5 weeks (mid-intervention), 10 weeks (post-intervention), 16 weeks (long-term follow-up))