Mindful self-compassion to reduce stigma among individuals diagnosed with lung cancer (MSC-LC): a pilot study protocol for a parallel-group, randomized controlled trial

正念自我关怀以减少肺癌患者的污名化(MSC-LC):一项平行组随机对照试验的试点研究方案

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Abstract

BACKGROUND: Lung cancer stigma (i.e., perceived and internalized negative appraisal and devaluation associated with lung cancer) is a clinically significant psychosocial concern among individuals diagnosed with lung cancer. Stigma has been linked to increased psychological distress, higher depressive symptoms, anxiety, lower quality of life, and reduced engagement in care. However, few patient-centered interventions address lung cancer stigma. Mindful Self-Compassion (MSC) is a promising approach that promotes emotional resilience and reduces psychological distress. However, MSC has not been tailored for the needs of people with lung cancer. To address this gap, we developed Mindful Self-Compassion for Lung Cancer (MSC-LC)-a disease-specific adaptation designed to reduce stigma by cultivating self-compassion. This study aims to assess the feasibility, acceptability, and preliminary efficacy of MSC-LC among individuals with lung cancer who report elevated stigma. METHODS: Theoretically grounded in the Conceptual Model of Lung Cancer Stigma, the Health Stigma and Discrimination Framework, and the CDC Map of Adaptation, this pilot trial uses a parallel-group randomized controlled design (1:1 allocation) comparing MSC-LC to an enhanced standard-of-care waitlist control group (CTL). We aim to enroll 60 adults diagnosed with lung cancer (n=30 per condition) who exceed a validated cutoff for elevated stigma on the Lung Cancer Stigma Inventory. MSC-LC includes weekly 90-min virtual group sessions co-facilitated by trained interventionists and home practice assignments between sessions. Feasibility and treatment fidelity (primary outcomes) will be assessed using quantitative benchmarks (e.g., recruitment, retention, session attendance, interventionist adherence). Acceptability will be evaluated through qualitative interviews. Secondary outcomes including stigma, self-compassion, depressive symptoms, anxiety, and spiritual well-being will be collected at baseline, mid-intervention, post-intervention, and longer-term follow-up. Quantitative and qualitative data will be integrated at the interpretation phase to examine signals of change and inform refinement and implementation. DISCUSSION: This study will address the gap of patient-centered interventions that target the reduction of lung cancer stigma. Findings will inform the rigorous evaluation of the efficacy of MSC-LC to reduce stigma among individuals with lung cancer. TRIAL REGISTRATION: The protocol for this study has been registered on ClinicalTrials.gov (ID: NCT06191939). First posted December 20, 2023, last update posted July 17, 2025. https://clinicaltrials.gov/study/NCT06191939 .

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