PTSD Mobile App for Cancer Survivors

Cancer Clinical Trial

Official title:

Using a SMART Design to Optimize PTSD Symptom Management Strategies Among Cancer Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04058795
• Other study ID #: Pro00103154
• Status: Recruiting
• Phase: N/A
• Start date: January 24, 2021
• Est. completion date: February 28, 2025

Study information

• Verified date: February 2024
• Source: Duke University
• Contact: Sophia K Smith, PhD, MSW
• Phone: 919-684-9628
• Email: sophia.smith[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: February 28, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• Cancer Distress Coach (CaDC) App
an app that provides participants with tools to manage their stress in the moment they experience it.
• CaDC + mCoaching
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.
• mCBT
8 mobile sessions with a therapist to receive cognitive behavioral therapy.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina
United States	Memorial Sloan Kettering	New York	New York
United States	Fred Hutchinson Cancer Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in distress measured by the Distress Thermometer v. 2018	Distress Thermometer v. 2018 is a one item instrument scored 0-10, with 0 being "No distress" and 10 being "Extreme distress"	baseline, 4 weeks, 12 weeks, and 6 months
Secondary	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, 12 weeks, 6 months
Secondary	Change in Quality of Life measured by the PROMIS QOL	PROMIS QOL is a 10 item instrument scored 1-5, with 1 being "Never" and 5 being "Always"	baseline, 4 weeks, 12 weeks, and 6 months
Secondary	Change in depression as measured by the PROMIS	PROMIS is an 8 item instrument scored 1-5, with 1 being "Never" and 5 being "Always"	baseline, 4 weeks, 12 weeks, and 6 months
Secondary	Change in anxiety as measured by the PROMIS	PROMIS is an 8 item instrument scored 1-5, with 1 being "Never" and 5 being "Always"	baseline, 4 weeks, 12 weeks, and 6 months
Secondary	Change in self-efficacy as measured by the Self-efficacy for Chronic Disease	Self-efficacy for Chronic Disease is a 6 item instrument scored 1-10, with 1 being "Not at all confident" and 10 being "totally confident"	baseline, 4 weeks, 12 weeks, and 6 months
Secondary	User satisfaction as measured by a survey	Team developed survey that will include questions regarding the participant's experience	baseline, 4 weeks, 12 weeks, and 6 months

External Links

•   Study Website