Sophia K Smith1, Tamara J Somers2, Eric Kuhn3, Eric Laber4, Anthony D Sung5, Karen L Syrjala6, Bryan Feger7, Sarah A Kelleher8, Catherine Majestic8, Rebecca Gebert9, Matthew LeBlanc10, Jason E Owen11, Allison J Applebaum12. 1. School of Nursing, Duke University, Durham, NC, United States of America; Duke Cancer Institute, Duke University Medical Center, Durham, NC, United States of America. Electronic address: sophia.smith@duke.edu. 2. Duke Cancer Institute, Duke University Medical Center, Durham, NC, United States of America; Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States of America. 3. Dissemination and Training Division, National Center for PTSD, Palo Alto, CA, United States of America; Department of Psychiatry and Behavioral Sciences, School of Medicine, Stanford University, Stanford, CA, United States of America. 4. Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, United States of America. 5. Duke Cancer Institute, Duke University Medical Center, Durham, NC, United States of America; Department of Medicine, Division of Hematologic Malignancies and Cellular Therapy, Duke University, Durham, NC, United States of America. 6. Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America. 7. Duke Clinical Research Institute, Durham, NC, United States of America. 8. Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States of America. 9. Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY, United States of America. 10. School of Nursing, Duke University, Durham, NC, United States of America. 11. Dissemination and Training Division, National Center for PTSD, Palo Alto, CA, United States of America. 12. Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY, United States of America; Department of Psychology in Psychiatry, Weill Cornell Medicine, New York, NY, United States of America.
Abstract
BACKGROUND/AIMS: Many cancer survivors who received intensive treatment such as hematopoietic stem cell transplantation (HCT) experience posttraumatic stress disorder (PTSD) symptoms. PTSD is associated with lower quality of life and other symptoms that require clinical treatment. The iterative treatment decisions that happen in clinical practice are not adequately represented in traditional randomized controlled trials (RCT) of PTSD treatments. The proposed stepped-care SMART design allows for evaluation of initial response to the Cancer Distress Coach mobile app; adaptive stepped-care interventions; and precision treatment strategies that tailor treatment selection to patient characteristics. METHODS/ DESIGN: HCT survivors (N = 400) reporting PTSD symptoms are being recruited at two cancer centers and randomly assigned to: 1) Cancer Distress Coach app or 2) Usual Care. The app includes educational and cognitive behavioral therapy (CBT)-based activities. Four weeks post-randomization, participants re-rate their PTSD symptoms and, based on intervention response, non-responders are re-randomized to receive video-conferenced sessions with a therapist: 3) coaching sessions in using the mobile app; or 4) CBT specific to HCT survivors. Participants complete outcome measures of PTSD, depression, and anxiety after Months 1, 3, and 6. Participant characteristics moderating intervention responses will be examined. CONCLUSIONS: This novel adaptive trial design will afford evidence that furthers knowledge about optimizing PTSD interventions for HCT survivors. To our knowledge, this study is the first SMART design evaluating PTSD symptom management in cancer survivors. If successful, it could be used to optimize treatment among a range of cancer and other trauma survivors.
BACKGROUND/AIMS: Many cancer survivors who received intensive treatment such as hematopoietic stem cell transplantation (HCT) experience posttraumatic stress disorder (PTSD) symptoms. PTSD is associated with lower quality of life and other symptoms that require clinical treatment. The iterative treatment decisions that happen in clinical practice are not adequately represented in traditional randomized controlled trials (RCT) of PTSD treatments. The proposed stepped-care SMART design allows for evaluation of initial response to the Cancer Distress Coach mobile app; adaptive stepped-care interventions; and precision treatment strategies that tailor treatment selection to patient characteristics. METHODS/ DESIGN: HCT survivors (N = 400) reporting PTSD symptoms are being recruited at two cancer centers and randomly assigned to: 1) Cancer Distress Coach app or 2) Usual Care. The app includes educational and cognitive behavioral therapy (CBT)-based activities. Four weeks post-randomization, participants re-rate their PTSD symptoms and, based on intervention response, non-responders are re-randomized to receive video-conferenced sessions with a therapist: 3) coaching sessions in using the mobile app; or 4) CBT specific to HCT survivors. Participants complete outcome measures of PTSD, depression, and anxiety after Months 1, 3, and 6. Participant characteristics moderating intervention responses will be examined. CONCLUSIONS: This novel adaptive trial design will afford evidence that furthers knowledge about optimizing PTSD interventions for HCT survivors. To our knowledge, this study is the first SMART design evaluating PTSD symptom management in cancer survivors. If successful, it could be used to optimize treatment among a range of cancer and other trauma survivors.
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Authors: Areej El-Jawahri; Lara Traeger; Joseph A Greer; Harry VanDusen; Sarah R Fishman; Thomas W LeBlanc; William F Pirl; Vicki A Jackson; Jason Telles; Alison Rhodes; Zhigang Li; Thomas R Spitzer; Steven McAfee; Yi-Bin A Chen; Jennifer S Temel Journal: J Clin Oncol Date: 2017-09-19 Impact factor: 44.544
Authors: Paul B Jacobsen; Ian J Sadler; Margaret Booth-Jones; Elizabeth Soety; Michael A Weitzner; Karen K Fields Journal: J Consult Clin Psychol Date: 2002-02
Authors: Alyssa L Fenech; Olivia Van Benschoten; Annemarie D Jagielo; Nneka N Ufere; Carlisle E W Topping; Madison Clay; Bailey T Jones; Lara Traeger; Jennifer S Temel; Areej El-Jawahri Journal: Transplant Cell Ther Date: 2021-01-16
Authors: Areej R El-Jawahri; Harry B Vandusen; Lara N Traeger; Joel N Fishbein; Tanya Keenan; Emily R Gallagher; Joseph A Greer; William F Pirl; Vicki A Jackson; Thomas R Spitzer; Yi-Bin A Chen; Jennifer S Temel Journal: Cancer Date: 2015-12-09 Impact factor: 6.860