A SMART approach to optimizing delivery of an mHealth intervention among cancer survivors with posttraumatic stress symptoms.

Journal Article (Journal Article)

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.

Full Text

Duke Authors

Cited Authors

  • Smith, SK; Somers, TJ; Kuhn, E; Laber, E; Sung, AD; Syrjala, KL; Feger, B; Kelleher, SA; Majestic, C; Gebert, R; LeBlanc, M; Owen, JE; Applebaum, AJ

Published Date

  • November 2021

Published In

Volume / Issue

  • 110 /

Start / End Page

  • 106569 -

PubMed ID

  • 34536584

Pubmed Central ID

  • PMC8595815

Electronic International Standard Serial Number (EISSN)

  • 1559-2030

Digital Object Identifier (DOI)

  • 10.1016/j.cct.2021.106569


  • eng

Conference Location

  • United States