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OpenTrials
Completed

NCT Number: NCT04058795

PTSD Mobile App for 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.

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Key information

Conditions

Posttraumatic Stress Disorder Anxiety Disorders Behavior Behavioral Symptoms Cancer Depression Mental Disorders Neoplasms Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cancer Distress Coach (CaDC) App

Behavioral

an app that provides participants with tools to manage their stress in the moment they experience it.

CaDC + mCoaching

Behavioral

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

Behavioral

8 mobile sessions with a therapist to receive cognitive behavioral therapy.

Primary outcomes

  1. 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"

Secondary outcomes

  1. 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"

  2. 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"

  3. 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"

  4. 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"

  5. 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"

  6. 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"

  7. 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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 16, 2019
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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