PO113 - SupportSarc: Protocol for A Randomized Controlled Trial of Virtual Mindfulness-Based Stress Reduction for Sarcoidosis-Associated Fatigue
Logan J Harper MD, MS (United States)1; Angie Corrigan (United States)2; Amanda J Shallcross ND, MPH (United States)2; Xiaofeng Wang PhD (United States)3; Donita Al-Amin (United States)1; Dena Aruta BS, MT (ASCP) (United States)1; Kathleen Pantea LPN (United States)1; Johnie Reed DBA (United States)1; Marc Judson MD (United States)4; Daniel A Culver DO (United States)1;
1 - Cleveland Clinic - Pulmonary Medicine; 2 - Cleveland Clinic - Wellness; 3 - Cleveland Clinic - Quantitative Health Sciences; 4 - Albany Medical Center - Pulmonary Medicine;
Keywords: Fatigue; Mindfulness; Trial;
Select the theme: Sarcoidosis Associated-fatigue
Type: Original Papers
Presentation: Poster Presentation

Introduction: Sarcoidosis-associated fatigue is prevalent and poorly addressed by pharmacologic therapy. Mindfulness-Based Stress Reduction (MBSR) targets stress reactivity and somatic symptoms and may be well-suited to sarcoidosis-associated fatigue, yet has not been tested in this population. Clinical trials in sarcoidosis have historically faced recruitment challenges, particularly among Black patients who bear disproportionate disease burden.

Objectives: To describe the design of SupportSarc, a randomized controlled trial of video-delivered MBSR (vMBSR) for sarcoidosis-associated fatigue, and to report early recruitment outcomes.

Materials and Methods: : SupportSarc is a multi-center, open-label, Type 1 hybrid effectiveness-implementation trial. One hundred adults with sarcoidosis and significant fatigue (Fatigue Assessment Scale ≥22) will be randomized 1:1 to 8 weeks of vMBSR or invitation to an existing virtual sarcoidosis support group. The primary outcome is change in PROMIS Fatigue at 8 and 20 weeks. Secondary outcomes include quality of life, depression, anxiety, and mindfulness. The vMBSR program was co-developed with a sarcoidosis Community Advisory Board and informed by qualitative interviews with patients from socioeconomically deprived neighborhoods. Common barriers to trial enrollment including limited transportation, work schedule constraints, and limited social support were addressed by making all activities fully virtual and phone-accessible, scheduling sessions in the evening, and designing both interventions to foster peer connection. Recruitment targeted ≥40% Black enrollment, with non-Black enrollment paused at 60% of the planned cohort, and targeted outreach conducted through majority-Black clinical sites and a disease-specific patient registry.

Results: The first cohort of 32 participants was enrolled across multiple sites within 6 weeks, with 44% identifying as Black, meeting our racial diversity target.

Conclusions: SupportSarc will generate rigorous evidence for a scalable, non-pharmacologic treatment for sarcoidosis-associated fatigue. Rapid, diverse recruitment suggests that intentionally removing structural and logistical barriers to participation may be a replicable strategy for improving enrollment of Black patients in sarcoidosis research.