PTSD Mobile App for Cancer Survivors

July 29, 2025 updated by: Duke University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

524

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cancer Distress Coach (CaDC)
Participants in this group will get the mHealth CaDC app, which will give them tools based on cognitive behavioral therapy principles to manage their stress.
Behavioral: Cancer Distress Coach (CaDC) App
an app that provides participants with tools to manage their stress in the moment they experience it.
Experimental: CaDC and mCoaching
Participants in this group will get both the CaDC app and weekly clinician support.
Behavioral: 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.
Experimental: mCBT
Participants in this group will get 8-sessions with a therapist to receive cognitive behavioral therapy (CBT).
Behavioral: mCBT
8 mobile sessions with a therapist to receive cognitive behavioral therapy.
No Intervention: Control
Participants 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in PTSD symptoms measured by the PTSD checklist (PCL5)
Time Frame: baseline, 4 weeks, 12 weeks
PCL5 is 20 item instrument scored 0-4, with 0 being "Not at all" and 4 being "Extremely"
baseline, 4 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in distress measured by the Distress Thermometer v. 2018
Time Frame: baseline, 4 weeks, 12 weeks, and 6 months
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
Change in PTSD symptoms measured by the PTSD checklist (PCL5)
Time Frame: baseline, 12 weeks, 6 months
PCL5 is 20 item instrument scored 0-4, with 0 being "Not at all" and 4 being "Extremely"
baseline, 12 weeks, 6 months
Change in Quality of Life measured by the PROMIS QOL
Time Frame: baseline, 4 weeks, 12 weeks, and 6 months
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
Change in depression as measured by the PROMIS
Time Frame: baseline, 4 weeks, 12 weeks, and 6 months
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
Change in anxiety as measured by the PROMIS
Time Frame: baseline, 4 weeks, 12 weeks, and 6 months
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
Change in self-efficacy as measured by the Self-efficacy for Chronic Disease
Time Frame: baseline, 4 weeks, 12 weeks, and 6 months
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
User satisfaction as measured by a survey
Time Frame: baseline, 4 weeks, 12 weeks, and 6 months
Team developed survey that will include questions regarding the participant's experience
baseline, 4 weeks, 12 weeks, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Sophia K Smith, PhD, MSW, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2021

Primary Completion (Actual)

May 1, 2025

Study Completion (Actual)

May 29, 2025

Study Registration Dates

First Submitted

August 14, 2019

First Submitted That Met QC Criteria

August 14, 2019

First Posted (Actual)

August 16, 2019

Study Record Updates

Last Update Posted (Actual)

July 30, 2025

Last Update Submitted That Met QC Criteria

July 29, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00103154

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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