Clinical trial NCT04058795: PTSD Mobile App for Cancer Survivors
Official title: Using a SMART Design to Optimize PTSD Symptom Management Strategies Among Cancer Survivors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Posttraumatic Stress Disorder
Cancer
Keywords: PTSD
Depression
Anxiety
Distress
Digital Health
mHealth
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-08-16
Enrollment: 524
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* If the participant does not fulfill the inclusion criteria

Primary outcomes:
measure: Change in PTSD symptoms measured by the PTSD checklist (PCL5)
timeFrame: baseline, 4 weeks, 12 weeks
Secondary outcomes:
measure: Change in distress measured by the Distress Thermometer v. 2018
timeFrame: baseline, 4 weeks, 12 weeks, and 6 months
measure: Change in PTSD symptoms measured by the PTSD checklist (PCL5)
timeFrame: baseline, 12 weeks, 6 months
measure: Change in Quality of Life measured by the PROMIS QOL
timeFrame: baseline, 4 weeks, 12 weeks, and 6 months
measure: Change in depression as measured by the PROMIS
timeFrame: baseline, 4 weeks, 12 weeks, and 6 months
measure: Change in anxiety as measured by the PROMIS
timeFrame: baseline, 4 weeks, 12 weeks, and 6 months
measure: Change in self-efficacy as measured by the Self-efficacy for Chronic Disease
timeFrame: baseline, 4 weeks, 12 weeks, and 6 months
measure: User satisfaction as measured by a survey
timeFrame: baseline, 4 weeks, 12 weeks, and 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
Study officials:
affiliation: Duke University
name: Sophia K Smith, PhD, MSW
role: PRINCIPAL_INVESTIGATOR
References: