Back to resultsPTSD Mobile App for Cancer Survivors
Primary Purpose
Posttraumatic Stress Disorder, Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cancer Distress Coach (CaDC) App
CaDC + mCoaching
mCBT
Sponsored by
About this trial
This is an interventional supportive care trial for Posttraumatic Stress Disorder focused on measuring PTSD, Depression, Anxiety, Distress, Digital Health, mHealth
Eligibility Criteria
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
Sites / Locations
- Memorial Sloan KetteringRecruiting
- Duke UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
Cancer Distress Coach (CaDC)
CaDC and mCoaching
mCBT
Control
Arm Description
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.
Participants in this group will get both the CaDC app and weekly clinician support.
Participants in this group will get 8-sessions with a therapist to receive cognitive behavioral therapy (CBT).
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.
Outcomes
Primary Outcome Measures
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"
Secondary Outcome Measures
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"
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"
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"
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"
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"
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"
User satisfaction as measured by a survey
Team developed survey that will include questions regarding the participant's experience
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04058795
Brief Title
PTSD Mobile App for Cancer Survivors
Official Title
Using a SMART Design to Optimize PTSD Symptom Management Strategies Among Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2021 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Cancer
Keywords
PTSD, Depression, Anxiety, Distress, Digital Health, mHealth
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cancer Distress Coach (CaDC)
Arm Type
Experimental
Arm Description
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.
Arm Title
CaDC and mCoaching
Arm Type
Experimental
Arm Description
Participants in this group will get both the CaDC app and weekly clinician support.
Arm Title
mCBT
Arm Type
Experimental
Arm Description
Participants in this group will get 8-sessions with a therapist to receive cognitive behavioral therapy (CBT).
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cancer Distress Coach (CaDC) App
Intervention Description
an app that provides participants with tools to manage their stress in the moment they experience it.
Intervention Type
Behavioral
Intervention Name(s)
CaDC + mCoaching
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
mCBT
Intervention Description
8 mobile sessions with a therapist to receive cognitive behavioral therapy.
Primary Outcome Measure Information:
Title
Change in PTSD symptoms measured by the PTSD checklist (PCL5)
Description
PCL5 is 20 item instrument scored 0-4, with 0 being "Not at all" and 4 being "Extremely"
Time Frame
baseline, 4 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Change in distress measured by the Distress Thermometer v. 2018
Description
Distress Thermometer v. 2018 is a one item instrument scored 0-10, with 0 being "No distress" and 10 being "Extreme distress"
Time Frame
baseline, 4 weeks, 12 weeks, and 6 months
Title
Change in PTSD symptoms measured by the PTSD checklist (PCL5)
Description
PCL5 is 20 item instrument scored 0-4, with 0 being "Not at all" and 4 being "Extremely"
Time Frame
baseline, 12 weeks, 6 months
Title
Change in Quality of Life measured by the PROMIS QOL
Description
PROMIS QOL is a 10 item instrument scored 1-5, with 1 being "Never" and 5 being "Always"
Time Frame
baseline, 4 weeks, 12 weeks, and 6 months
Title
Change in depression as measured by the PROMIS
Description
PROMIS is an 8 item instrument scored 1-5, with 1 being "Never" and 5 being "Always"
Time Frame
baseline, 4 weeks, 12 weeks, and 6 months
Title
Change in anxiety as measured by the PROMIS
Description
PROMIS is an 8 item instrument scored 1-5, with 1 being "Never" and 5 being "Always"
Time Frame
baseline, 4 weeks, 12 weeks, and 6 months
Title
Change in self-efficacy as measured by the Self-efficacy for Chronic Disease
Description
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"
Time Frame
baseline, 4 weeks, 12 weeks, and 6 months
Title
User satisfaction as measured by a survey
Description
Team developed survey that will include questions regarding the participant's experience
Time Frame
baseline, 4 weeks, 12 weeks, and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophia K Smith, PhD, MSW
Phone
919-684-9628
Email
sophia.smith@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophia K Smith, PhD, MSW
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allison Applebaum, PhD
Phone
646-888-0034
Email
ApplebaA@mskcc.org
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophia Smith, PhD
Phone
919-684-9628
Email
sophia.smith@duke.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://sites.duke.edu/transplantsurvivorcoach/contact-us/
Description
Study Website
Learn more about this trial
PTSD Mobile App for Cancer Survivors
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