PTSD Mobile App for Cancer Survivors
Using a SMART Design to Optimize PTSD Symptom Management Strategies Among Cancer Survivors
1 other identifier
interventional
524
1 country
3
Brief Summary
The purpose of this study is to use a stepped-care approach in treating symptoms of posttraumatic stress disorder (PTSD). The information learned by doing this study may help us to develop some target treatments for PTSD symptoms in survivors of stem cell transplant. Participants in this study will be randomized to a mobile app or usual care. An assessment will be made after 4 weeks and a determination made of adding more intensive treatment. Participants will be asked to complete a questionnaire 4 times over a period of 6 months, at the time your participation is complete.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2019
CompletedFirst Posted
Study publicly available on registry
August 16, 2019
CompletedStudy Start
First participant enrolled
January 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 29, 2025
CompletedJuly 30, 2025
April 1, 2025
4.3 years
August 14, 2019
July 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in PTSD symptoms measured by the PTSD checklist (PCL5)
PCL5 is 20 item instrument scored 0-4, with 0 being "Not at all" and 4 being "Extremely"
baseline, 4 weeks, 12 weeks
Secondary Outcomes (7)
Change in distress measured by the Distress Thermometer v. 2018
baseline, 4 weeks, 12 weeks, and 6 months
Change in PTSD symptoms measured by the PTSD checklist (PCL5)
baseline, 12 weeks, 6 months
Change in Quality of Life measured by the PROMIS QOL
baseline, 4 weeks, 12 weeks, and 6 months
Change in depression as measured by the PROMIS
baseline, 4 weeks, 12 weeks, and 6 months
Change in anxiety as measured by the PROMIS
baseline, 4 weeks, 12 weeks, and 6 months
- +2 more secondary outcomes
Study Arms (4)
Cancer Distress Coach (CaDC)
EXPERIMENTALParticipants in this group will get the mHealth CaDC app, which will give them tools based on cognitive behavioral therapy principles to manage their stress.
CaDC and mCoaching
EXPERIMENTALParticipants in this group will get both the CaDC app and weekly clinician support.
mCBT
EXPERIMENTALParticipants in this group will get 8-sessions with a therapist to receive cognitive behavioral therapy (CBT).
Control
NO INTERVENTIONParticipants in this group can use mental health services commonly available to all cancer patients at their local medical facility but will not receive access to the CaDC app.
Interventions
an app that provides participants with tools to manage their stress in the moment they experience it.
The CaDC app plus weekly clinician support which provides support in navigating the app, encouraging adherence to the use of the CaDC, and providing guidance in choosing treatment strategies.
Eligibility Criteria
You may qualify if:
- Completion of autologous or allogeneic HCT 1-5 years previously
- Partial or complete remission (NED), may be receiving chemoprevention
- Absence of severe psychological impairment (eg hospitalization for suicidality)
- Approved for contact by oncologist
- Able and willing to participate in a one-hour baseline interview
- No prior CBT for PTSD
- Owns a smart device with internet and email access
- Able to read and write English
- Significant PTSD symptoms as indicated by at least one of the following two criteria: probable cancer-related PTSD on the PCL5 by using the symptom cluster criteria; subthreshold or partial PTSD symptoms as determined by endorsement of reexperiencing cluster and less than or equal to 1 other symptom cluster
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (3)
Memorial Sloan Kettering
New York, New York, 10065, United States
Duke University
Durham, North Carolina, 27710, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
Related Publications (1)
Smith SK, Manschot C, Kuhn E, Laber E, Somers TJ, Syrjala KL, Applebaum AJ. Assessing the utility of the PC-PTSD-5 as a screening tool among a cancer survivor sample. Cancer. 2024 Dec 1;130(23):4118-4126. doi: 10.1002/cncr.35504. Epub 2024 Aug 14.
PMID: 39141666DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sophia K Smith, PhD, MSW
Duke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2019
First Posted
August 16, 2019
Study Start
January 24, 2021
Primary Completion
May 1, 2025
Study Completion
May 29, 2025
Last Updated
July 30, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share