PTSD Mobile App for Cancer Survivors

Study Overview
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Brief Summary
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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.

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

Conditions
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Posttraumatic Stress Disorder, Cancer

Intervention / Treatment
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* Behavioral: Cancer Distress Coach (CaDC) App
* Behavioral: CaDC + mCoaching
* Behavioral: mCBT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cancer Distress Coach (CaDC)<br>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<br>* an app that provides participants with tools to manage their stress in the moment they experience it.<br>|
| Experimental: CaDC and mCoaching<br>Participants in this group will get both the CaDC app and weekly clinician support. | Behavioral: CaDC + mCoaching<br>* 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.<br>|
| Experimental: mCBT<br>Participants in this group will get 8-sessions with a therapist to receive cognitive behavioral therapy (CBT). | Behavioral: mCBT<br>* 8 mobile sessions with a therapist to receive cognitive behavioral therapy.<br>|
| No Intervention: Control<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Depression, Anxiety, Distress, Digital Health, mHealth