Oral Presentation 2025 Joint Meeting of the COSA ASM and IPOS Congress

Using a SMART Design while Leveraging Digital Health to Optimize PTSD Symptom Management Strategies Among Hematopoietic Transplant Cancer Survivors (125625)

Sophia K Smith 1 , Eric Kuhn 2 , Cole Manschot 3 , Tamara Somers 4 , Sarah Kelleher 4 , Catherine Majestic 4 , Eric Laber 5 , Anthony Sung 6 , Sergio Giralt 7 , Deborah K Mayer 8 , Karen L Syrjala 9 , Allison J Applebaum 10
  1. Duke University, Durham, NC, United States
  2. Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA
  3. Department of Statistics, NC State University, Raleigh , NC, USA
  4. Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC , USA
  5. Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, 27710
  6. School of Medicine, University of Kansas, Kansas City, Kansas, USA
  7. Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA
  8. School of Nursing, University of North Carolina, Chapel Hill, NC, USA
  9. Clinical Research Division, Fred Hutch Cancer Center, Seattle, WA, USA
  10. Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA

Objectives. Hematopoietic cell transplantation (HCT) cancer survivors face elevated risk for posttraumatic stress disorder (PTSD) symptoms, yet access to effective treatment remains limited. This study (R01-CA244172) evaluated a stepped-care, adaptive digital health intervention using a Sequential Multiple Assignment Randomized Trial (SMART) design to optimize PTSD symptom management.

Sample and setting.  Adult cancer survivors (target N=470) who received autologous or allogeneic HCT 1–5 years prior, were in remission, and identified through transplant registries were recruited from three cancer centers and BMT Infonet. Inclusion criteria required significant PTSD symptoms [PTSD Checklist (PCL-5) score ≥31] and access to a smart device.  

Procedures. Participants were randomized to the Cancer Distress Coach (CaDC) app or Usual Care. At Month 1, non-responders (i.e., <5-point PCL-5 reduction) were re-randomized to receive CaDC+Coaching (i.e., app+therapist/coach) or HCT-specific CBT for PTSD (CBT-PTSD) virtually. PTSD symptoms (PCL-5) were assessed at Month 3 (post-intervention) and Month 6 (follow-up). The design enabled evaluation of initial treatment efficacy and six stepped-care strategies.

Results. Participants (N=477) were majority female (63%), white (82%), with a mean age of 52.6±13.7. Those in the CaDC arm showed greater PTSD symptom reduction at Month 3 compared to Usual Care (p=0.0378). Regimes including CBT-PTSD showed improvements over those without at 3 and 6 months. At 6 months, regimes beginning with CaDC were associated with greater PCL-5 score reductions than regimes beginning with Usual Care. All regimes with CaDC+Coaching and CBT-PTSD had large Cohen's d effect sizes at Month 3 (0.769, 0.887) and Month 6 (0.846, 0.920).

Conclusion and clinical implications.  This SMART study demonstrated the effectiveness of a stepped-care digital health approach for PTSD symptom management in HCT cancer survivors. CaDC is a promising first-line intervention, while CaDC+Coaching and CBT-PTSD offer substantial added benefits for non-responders. These findings inform scalable, personalized distress management strategies for cancer survivors.