Background: The foundation for the accreditation for cellular therapy (FACT) has published standards for hematopoietic cell therapy. The NIH Cure Sickle Cell Initiative (CureSCi) [i] has highlighted how the mental health and social readiness of sickle cell disease (SCD) candidates for curative therapy may be overlooked or undervalued. Virginia Commonwealth University Health (VCUHS) has therefore adapted CureSCi guidelines published in a white paper to develop a psychosocial readiness screening process intended to guide and support SCD patients and their potential curative therapy clinicians, as well as to enhance treatment adherence, completion, and success rates. The comprehensive process is designed to address potential barriers to adult SCD patients' psychosocial preparation for curative therapy.

Methods: Our interdisciplinary team (e.g., adult and pediatric mental health professionals, providers, and coordinators) met weekly to design the process. During the meetings, we reviewed the guidelines and other internal processes used for screening patients as part of existing gene therapy and transformative therapy processes. We also developed and revised the flow diagram of the process and the assessment tool by circulating it among the larger group for feedback.

Results: The process begins prior to a referral being made to the transplant team. The SCD team delivers the initial curative therapy education and performs a comprehensive, multi-step assessment of mental health. Education begins at the SCD medical assessment in the adult SCD clinic, conducted by SCD experts. The team assigns a case manager to patients who express interest and remain interested after initial medical screening and education. Behavioral health experts on the SCD team administer a thorough mental health readiness screening battery. The battery is comprised of scales and items carefully selected by consensus after several weekly meetings. The battery chosen considers respondent burden, thoroughness of mental health domain coverage, administrative prep and professional administration time, integration into the electronic health record and cellular and immunotherapy research database, and how to use CURESCi recommendations to form screening recommendations. The medical team trains behavioral and case management staff about the curative therapy process, to limit potential misinformation during behavioral health and case management encounters. The patient is never denied any opportunity to move forward with curative therapy, but the behavioral health recommendations are integrated with behavioral health and case management support during the years-long curative therapy preparation, procedure, and after-care. Final products include a time flow diagram for the screening process integrated into clinical care, and the mental health screening toolwhich outlines the categories which are administered to the patient.

Conclusion: Integrating a structured mental health prescreening process within the sickle cell team, as part of overall prescreening for curative therapy, ensures that SCD patients referred to CIT teams for curative therapy may be better prepared psychologically and socially. This assessment does not replace any mandates required by FACT certification, but provides a more detailed sickle-cell-specific assessment. Continuous education and mental health support are crucial in this process, requiring collaboration between providers, coordinators, and mental health professionals. Future work should include analysis of assessments administered using our template and the relationship of evaluations to curative therapy outcomes.

[i] Steven J. Hardy, Lori E. Crosby, Jerlym S. Porter, Soumitri Sil, Cecelia R. Valrie, Charles R. Jonassaint, Shawn M. Bediako, Clayton Andrews, Maria Rivera, Teonna Woolford, Victoria H. Coleman-Cowger; Assessing Psychosocial Readiness for Gene Therapy in Sickle Cell Disease: A Consensus Statement. Blood 2023; 142 (Supplement 1): 371. doi: https://doi.org/10.1182/blood-2023-190398

Disclosures

Johnson:Pfizer: Consultancy. Smith:Pfizer: Consultancy; Vertex: Honoraria.

This content is only available as a PDF.
Sign in via your Institution