Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
524 participants
INTERVENTIONAL
2021-01-24
2025-05-29
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Cancer Distress Coach (CaDC) App
an app that provides participants with tools to manage their stress in the moment they experience it.
CaDC and mCoaching
Participants in this group will get both the CaDC app and weekly clinician support.
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.
mCBT
Participants in this group will get 8-sessions with a therapist to receive cognitive behavioral therapy (CBT).
mCBT
8 mobile sessions with a therapist to receive cognitive behavioral therapy.
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.
No interventions assigned to this group
Interventions
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Cancer Distress Coach (CaDC) App
an app that provides participants with tools to manage their stress in the moment they experience it.
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.
mCBT
8 mobile sessions with a therapist to receive cognitive behavioral therapy.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Sophia K Smith, PhD, MSW
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Memorial Sloan Kettering
New York, New York, United States
Duke University
Durham, North Carolina, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Countries
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References
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Smith SK, Manschot C, Kuhn E, Laber E, Somers TJ, Syrjala KL, Applebaum AJ. Assessing the utility of the PC-PTSD-5 as a screening tool among a cancer survivor sample. Cancer. 2024 Dec 1;130(23):4118-4126. doi: 10.1002/cncr.35504. Epub 2024 Aug 14.
Provided Documents
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Document Type: Informed Consent Form
Related Links
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Other Identifiers
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Pro00103154
Identifier Type: -
Identifier Source: org_study_id
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