PTSD Mobile App for Cancer Survivors

Sponsor

Duke University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04058795

Collaborator

(none)

400

Enrollment

Locations

Arms

40.2

Anticipated Duration (Months)

200

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder Cancer	Behavioral: Cancer Distress Coach (CaDC) App Behavioral: CaDC + mCoaching Behavioral: mCBT	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jan 24, 2021

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

May 31, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Change in PTSD symptoms measured by the PTSD checklist (PCL5) [baseline, 4 weeks, 12 weeks]
PCL5 is 20 item instrument scored 0-4, with 0 being "Not at all" and 4 being "Extremely"

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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