Posttraumatic Stress DisorderNCT04058795
PTSD Mobile App for Cancer Survivors
A study testing Cancer Distress Coach (CaDC) App, CaDC + mCoaching and mCBT in people with Posttraumatic Stress Disorder and Cancer, run by Duke University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Posttraumatic Stress Disorder, Cancer
- What is being tested?
- Cancer Distress Coach (CaDC) App, CaDC + mCoaching and mCBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 524 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Jan 2021to 29 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- If the participant does not fulfill the inclusion criteria
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Duke University
Durham, North Carolina, 27710
Memorial Sloan Kettering
New York, New York, 10065
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
About this study
Official title: Using a SMART Design to Optimize PTSD Symptom Management Strategies Among Cancer Survivors
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.
- Conditions
- Posttraumatic Stress Disorder, Cancer
- Being tested
- Cancer Distress Coach (CaDC) App, CaDC + mCoaching, mCBT
- Keywords
- PTSD, Depression, Anxiety, Distress, Digital Health, mHealth
- Medical subject headings
- Stress Disorders, Post-Traumatic, Neoplasms, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer Distress Coach (CaDC) AppBehavioural
an app that provides participants with tools to manage their stress in the moment they experience it.
CaDC + mCoachingBehavioural
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.
mCBTBehavioural
8 mobile sessions with a therapist to receive cognitive behavioral therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cancer Distress Coach (CaDC) App |
| CaDC and mCoaching | Experimental | Participants in this group will get both the CaDC app and weekly clinician support. Receives: Behavioral: CaDC + mCoaching |
| mCBT | Experimental | Participants in this group will get 8-sessions with a therapist to receive cognitive behavioral therapy (CBT). Receives: Behavioral: mCBT |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: baseline, 4 weeks, 12 weeks
Secondary outcomes (7)
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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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
Measured: baseline, 4 weeks, 12 weeks, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start24 Jan 2021
- Primary completion1 May 2025
- Study completion29 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 524 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophia K Smith, PhD, MSW, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058795
- Sponsor's protocol ID
- Pro00103154
- Status last verified
- Apr 2025
- First submitted
- 14 Aug 2019
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smith SK, Kuhn E, Somers TJ, Laber E, Manschot C, Sung AD, Kelleher SA, Majestic C, Syrjala KL, Mayer D, Giralt S, Pires A, Gebert RR, Owen JE, Yi JC, Applebaum AJ. Adaptive, Stepped-Care for Cancer-Related PTSD Symptoms in HCT Survivors: Results From a SMART Trial. Psychooncology. 2026 Aug;35(8):e70554. doi: 10.1002/pon.70554.
PubMed 42565481Smith 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.
PubMed 39141666
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a SMART Design to Optimize PTSD Symptom Management Strategies Among Cancer Survivors
- ClinicalTrials.gov ID
- NCT04058795
- Acronym / sponsor ID
- Pro00103154
- Conditions
- Posttraumatic Stress Disorder, Cancer
- Keywords
- PTSD, Depression, Anxiety, Distress, Digital Health, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 524 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 24 Jan 2021 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 29 May 2025 (actual)
- First posted
- 16 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cancer Distress Coach (CaDC) | Experimental | Behavioral: Cancer Distress Coach (CaDC) AppParticipants in this group will get the mHealth CaDC app, which will give them tools based on cognitive behavioral therapy principles to manage their stress. |
| CaDC and mCoaching | Experimental | Behavioral: CaDC + mCoachingParticipants in this group will get both the CaDC app and weekly clinician support. |
| mCBT | Experimental | Behavioral: mCBTParticipants 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- If the participant does not fulfill the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cancer Distress Coach (CaDC) Appan app that provides participants with tools to manage their stress in the moment they experience it. | Behavioural | Cancer Distress Coach (CaDC) |
| CaDC + mCoachingThe 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. | Behavioural | CaDC and mCoaching |
| mCBT8 mobile sessions with a therapist to receive cognitive behavioral therapy. | Behavioural | mCBT |
Primary outcome
Change in PTSD symptoms measured by the PTSD checklist (PCL5)
Time frame: baseline, 4 weeks, 12 weeks
PCL5 is 20 item instrument scored 0-4, with 0 being "Not at all" and 4 being "Extremely"
7 secondary outcomes
Change in distress measured by the Distress Thermometer v. 2018
Time frame: baseline, 4 weeks, 12 weeks, and 6 months
Change in PTSD symptoms measured by the PTSD checklist (PCL5)
Time frame: baseline, 12 weeks, 6 months
Change in Quality of Life measured by the PROMIS QOL
Time frame: baseline, 4 weeks, 12 weeks, and 6 months
Change in depression as measured by the PROMIS
Time frame: baseline, 4 weeks, 12 weeks, and 6 months
Change in anxiety as measured by the PROMIS
Time frame: baseline, 4 weeks, 12 weeks, and 6 months
Change in self-efficacy as measured by the Self-efficacy for Chronic Disease
Time frame: baseline, 4 weeks, 12 weeks, and 6 months
User satisfaction as measured by a survey
Time frame: baseline, 4 weeks, 12 weeks, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Derived from this study: PubMed 42565481Smith SK, Kuhn E, Somers TJ, Laber E, Manschot C, Sung AD, Kelleher SA, Majestic C, Syrjala KL, Mayer D, Giralt S, Pires A, Gebert RR, Owen JE, Yi JC, Applebaum AJ. Adaptive, Stepped-Care for Cancer-Related PTSD Symptoms in HCT Survivors: Results From a SMART Trial. Psychooncology. 2026 Aug;35(8):e70554. doi: 10.1002/pon.70554.
- Derived from this study: PubMed 39141666Smith 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.
- Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophia K Smith, PhD, MSW principal investigator
Duke University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cancer Distress Coach (CaDC) App, CaDC + mCoaching and mCBT in people with Posttraumatic Stress Disorder and Cancer, run by Duke University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD symptoms measured by the PTSD checklist (PCL5) (time frame: baseline, 4 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04058795, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.