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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cancer Distress Coach (CaDC) | Experimental | 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. |
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| CaDC and mCoaching | Experimental | Participants in this group will get both the CaDC app and weekly clinician support. |
|
| mCBT | Experimental | Participants in this group will get 8-sessions with a therapist to receive cognitive behavioral therapy (CBT). |
|
| Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cancer Distress Coach (CaDC) App | Behavioral | an app that provides participants with tools to manage their stress in the moment they experience it. |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sophia K Smith, PhD, MSW | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering | New York | New York | 10065 | United States | ||
| Duke University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39141666 | Derived | 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. |
| Label | URL |
|---|---|
| Study Website | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 30, 2026 | |
| Reset | May 22, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 16, 2024 | Apr 28, 2025 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 30, 2026 | May 22, 2026 | |||
| Jun 17, 2026 |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D009369 | Neoplasms |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D000682 | Amyloid |
| ID | Term |
|---|---|
| D046912 | Multiprotein Complexes |
| D046911 | Macromolecular Substances |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| CaDC + mCoaching | Behavioral | 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 | Behavioral | 8 mobile sessions with a therapist to receive cognitive behavioral therapy. |
|
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 |
| Durham |
| North Carolina |
| 27710 |
| United States |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | United States |
| D001519 | Behavior |