A SMART approach to optimizing delivery of an mHealth intervention among cancer survivors with posttraumatic stress symptoms
Open accessAbstract
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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Adherence to intervention protocols is rated for 20% of randomly selected sessions, with a session-level adherence criterion of at least 90%.
“Ratings of adherence to the intervention protocols are made for 20% of randomly selected sessions. Criteria for protocol adherence is defined for each session as a score of ≥90% on an adherence rating scale39–41.”
From Improving well-being for individuals with persistent pain after surgery for breast cancer, lobular carcinoma in situ, or ductal carcinoma in situ: A randomized clinical trial (2022) · cites this paper as [41]
The Methods > Measures > Interventionist Adherence passage (page not provided) says 20% of mCoaching calls are randomly selected for fidelity checks and adherence ratings. It does not specify a ≥90% session-level criterion; it also says mCBT ratings initially cover 50% of sessions, falling to 20% after the first year. (LLM, conf=0.88)
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- Authors
- Smith, S. K., Somers, T. J., Kuhn, E., Laber, E., Sung, A. D., Syrjala, K. L., Feger, B., Kelleher, S. A., Majestic, C., Gebert, R., LeBlanc, M., Owen, J. E., & Applebaum, A. J.
- Affiliations
- Duke University (US)
- Stanford Medicine (US)
- Fred Hutch Cancer Center (US)
- Duke Clinical Research Institute (US)
- Memorial Sloan Kettering Cancer Center (US)
- Corresponding author
- Smith, Sophia K.
- ORCID
- Venue
- Contemporary Clinical Trials
- Publisher
- Elsevier BV
- Published
- 2021-11
- Volume
- 110
- Pages
- 106569
- ISSN
- 1551-7144 (ISSN-L)
- PMC
- PMC8595815
- OpenAlex
- W3199445527
- Cited by
- 14
- References
- 41
- Citations by year
- 2026: 3 · 2025: 6 · 2024: 1 · 2023: 2 · 2022: 2
- FWCI
- 0.45
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Licence
- Locations
- Contemporary Clinical Trials (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Cancer Institute (1R01-CA244172)
- National Institutes of Health
- Topics
- Health Sciences › Medicine › Oncology › Cancer survivorship and care
- Social Sciences › Psychology › Clinical Psychology › Posttraumatic Stress Disorder Research
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Keywords
- post-traumatic stress disorder, cancer survivors, hematopoietic stem cell transplantation, mobile health intervention, mobile application, stepped care, adaptive trial design, precision therapy, cognitive behavioral therapy, depression, anxiety, trauma survivors
- MeSH terms
- Cancer Survivors, Adaptive Clinical Trials as Topic, Anxiety, Humans, Neoplasms, Stress Disorders, Post-Traumatic, Multicenter Studies as Topic, Cognitive Behavioral Therapy, Randomized Controlled Trials as Topic, Telemedicine
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