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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
524

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 24, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 29, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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