PTSD Mobile App for Cancer Survivors

No longer recruiting at 2 trial locations

Overseen By Sophia K Smith, PhD, MSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Severe psychological impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist cancer survivors with PTSD (posttraumatic stress disorder) using a mobile app called the Cancer Distress Coach (CaDC). The app provides tools based on cognitive behavioral therapy (CBT) to help manage stress. Participants will join one of several groups to receive either the app, the app with coaching (CaDC + mCoaching), regular therapy sessions, or standard care. The trial seeks cancer survivors who underwent a stem cell transplant 1-5 years ago and are experiencing significant PTSD symptoms. As an unphased trial, this study offers participants a unique chance to contribute to innovative research that could enhance PTSD management for cancer survivors.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this mobile app is safe for cancer survivors?

Research has shown that mobile apps using cognitive behavioral therapy (CBT) methods, such as the Cancer Distress Coach (CaDC) app, are generally safe and well-liked. In a small study, 89.7% of cancer survivors reported being at least moderately satisfied with a similar app for managing PTSD. This indicates the app is usually well-tolerated, with no major safety issues reported.

Specific safety data for using the CaDC app with mCoaching (weekly support from a clinician) is not available. However, both app-based therapies and clinician support are common in mental health care and are generally considered safe.

For the mCBT (mobile cognitive behavioral therapy) option, studies have shown it effectively reduces PTSD symptoms compared to no treatment. No major safety concerns have been reported, suggesting it is well-tolerated.

Overall, these digital and therapeutic options appear safe based on past research, but discussing any concerns with a healthcare provider is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cancer Distress Coach (CaDC) app because it offers a unique, tech-driven approach to managing PTSD in cancer survivors. Unlike traditional therapy, which typically involves in-person sessions, the CaDC app provides immediate, on-the-go support using cognitive behavioral therapy (CBT) principles. This app empowers users with tools to manage stress at their own pace, which could be more convenient and accessible than standard therapy options. Additionally, the option to combine the app with weekly clinician support (in the CaDC and mCoaching arm) provides a blend of digital and human interaction, potentially enhancing the effectiveness of traditional therapy methods.

What evidence suggests that this trial's treatments could be effective for PTSD in cancer survivors?

Research shows that the Cancer Distress Coach (CaDC) app helps lower PTSD symptoms in cancer survivors. In a small study, 81% of users reported a significant drop in PTSD symptoms just four weeks after starting. Users also noted that the app improved their understanding of PTSD. In this trial, one group will receive the CaDC app alone, while another group will receive the CaDC app with additional coaching. Early results suggest that this combination may offer even more benefits for those needing extra support. Meanwhile, participants in a separate group will receive mobile cognitive behavioral therapy (mCBT), which has also proven effective in reducing PTSD symptoms. Specifically, participants using mCBT reported noticeable improvements in their condition after treatment. ^{1 6 7 8 9}

Who Is on the Research Team?

Sophia K Smith, PhD, MSW

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for cancer survivors who've had a stem cell transplant 1-5 years ago and are showing signs of PTSD but haven't received CBT for it. They must be able to use a smart device, read/write English, have their oncologist's approval, and not be severely psychologically impaired.

Inclusion Criteria

I am willing and able to do a one-hour interview.

You have severe PTSD symptoms related to cancer, which may include flashbacks, nightmares, or avoidance of certain situations. Or you have mild PTSD symptoms, such as re-experiencing events related to cancer and a few other symptoms.

I have not had cognitive behavioral therapy for PTSD.

Exclusion Criteria

If the participant does not fulfill the inclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants are randomized to a mobile app or usual care. An assessment will be made after 4 weeks.

4 weeks

1 visit (virtual)

Intensive Treatment

Based on the 4-week assessment, more intensive treatment may be added.

8 weeks

Weekly sessions (virtual or in-person)

Follow-up

Participants are monitored for changes in distress, anxiety, self-efficacy, PTSD symptoms, depression, and quality of life.

6 months

4 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• CaDC + mCoaching
• Cancer Distress Coach (CaDC) App
• mCBT

Trial Overview The study tests a mobile app called Cancer Distress Coach (CaDC), with or without additional coaching or mobile CBT (mCBT), against usual care. Participants will be randomly assigned to treatments and assessed over 6 months to see if the app helps reduce PTSD symptoms.

How Is the Trial Designed?

Group I: mCBT Experimental Treatment 1 Intervention

Participants in this group will get 8-sessions with a therapist to receive cognitive behavioral therapy (CBT).

Group II: Cancer Distress Coach (CaDC) Experimental Treatment 1 Intervention

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.

Group III: CaDC and mCoaching Experimental Treatment 1 Intervention

Participants in this group will get both the CaDC app and weekly clinician support.

Group IV: Control Active Control 1 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 Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

The iCanThrive app, combined with phone coaching, significantly reduced symptoms of depression and sleep disruption among 28 survivors of women's cancer over a 6-week period, indicating its potential efficacy as a mental health intervention.

With an 87% completion rate and positive user feedback, the app shows promise for scalability and accessibility in addressing the mental health needs of cancer survivors, warranting further validation in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Mobile Phone App Intervention With Phone Coaching to Reduce Symptoms of Depression in Survivors of Women's Cancer: Pre-Post Pilot Study. Chow, PI., Drago, F., Kennedy, EM., et al.[2020]

A systematic review of 11 randomized trials involving 2249 breast cancer survivors found that psychological mobile health interventions, primarily based on cognitive behavioral therapy, showed limited effectiveness in improving mental health outcomes, with only a few studies reporting significant short-term benefits for psychological distress.

Despite some short-term improvements in specific areas like distress and anxiety, there was no evidence of long-term benefits beyond three months, and a notable percentage of participants either did not start or discontinued the interventions, highlighting the need for better-designed studies in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review on the effectiveness of mobile health applications on mental health of breast cancer survivors. Horn, A., Jírů-Hillmann, S., Widmann, J., et al.[2023]

The Swedish version of the PTSD Coach app was found to be slightly to moderately helpful and satisfactory for users, with 11 participants reporting nominal reductions in posttraumatic stress symptoms (PTSS) and depression after four weeks of use.

Despite some positive feedback on specific features like symptom monitoring and breathing exercises, participants reported lower engagement with the app than expected, indicating a need for improvements in app structure and user guidance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of user satisfaction and perceived helpfulness of the Swedish version of the mobile app PTSD Coach. Cernvall, M., Sveen, J., Bergh Johannesson, K., et al.[2023]

The Distress Thermometer and Problem List (DT&PL) was implemented in a study with 220 cancer patients undergoing treatment, but it did not significantly improve psychological distress or quality of life outcomes over 12 months.

Despite being a quick and inexpensive tool, costing £19 ($28) per patient, the DT&PL did not reduce healthcare costs or lead to referrals for psychological support, indicating a need for better strategies to address patient distress in oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are needs assessments cost effective in reducing distress among patients with cancer? A randomized controlled trial using the Distress Thermometer and Problem List. Hollingworth, W., Metcalfe, C., Mancero, S., et al.[2022]

The introduction of PTSD as a diagnosis for cancer patients highlights the need to adjust trauma criteria specifically for this group, indicating that their experiences may differ from traditional PTSD cases.

There is a lack of comprehensive data on risk factors for PTSD in cancer patients, emphasizing the need for prospective, longitudinal studies to better understand its prevalence and to identify at-risk individuals for timely assessment and intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of posttraumatic psychological problems in cancer patients. Schmitt, A., Singer, S., Schwarz, R.[2019]

This systematic review analyzed 76 articles on interventions for Post-Traumatic Stress Symptoms (PTSS) and Post-Traumatic Growth (PTG) in cancer survivors, highlighting that most studies focused on promoting PTG through methods like psychotherapy and mindfulness.

Key recommendations for future research include designing interventions based on clear mechanisms, ensuring better representation of cancer survivors in studies, and identifying factors that enhance the effectiveness of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-traumatic stress symptoms, post-traumatic stress disorder, and post-traumatic growth among cancer survivors: a systematic scoping review of interventions. Capaldi, JM., Shabanian, J., Finster, LB., et al.[2023]

A new electronic stress management intervention called StressProffen was developed for cancer survivors, based on user-centered design principles and input from 48 stakeholders, including cancer survivors and healthcare providers.

The intervention was tailored to be mobile-friendly and user-friendly, emphasizing brief content and easy access, which aligns with cancer survivors' preferences for managing stress effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Stress Management App Intervention for Cancer Survivors: Design, Development, and Usability Testing. Børøsund, E., Mirkovic, J., Clark, MM., et al.[2020]

In a study involving 449 patients with nonmetastatic cancer, those using an app-based cognitive behavioral stress management (CBSM) showed significant reductions in anxiety and depression symptoms over 12 weeks compared to a health education sham app.

Patients using the CBSM app reported a greater perception of improvement in their anxiety and depression symptoms, indicating that this digital intervention is effective in managing emotional distress in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Cognitive Behavioral Digital Therapeutic on Anxiety and Depression Symptoms in Patients With Cancer: A Randomized Controlled Trial. Zion, SR., Taub, CJ., Heathcote, LC., et al.[2023]

The study is evaluating the effectiveness of the Cancer Distress Coach mobile app versus usual care in 400 hematopoietic stem cell transplantation survivors experiencing PTSD symptoms, aiming to improve their quality of life.

Using a novel stepped-care SMART design, the trial will adapt treatment based on individual responses, potentially leading to more personalized and effective PTSD interventions for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A SMART approach to optimizing delivery of an mHealth intervention among cancer survivors with posttraumatic stress symptoms. Smith, SK., Somers, TJ., Kuhn, E., et al.[2023]

Clinicians rated the PTSD Coach Australia app as having an 'average' to 'good' quality, viewing it as a useful tool for tracking symptoms and enhancing engagement between therapy sessions.

Despite its potential benefits, clinicians raised concerns about the app's user-friendliness and technical issues, such as freezing on Android devices, highlighting the need for improvements to ensure better usability for Defence members.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinicians' perceptions of PTSD Coach Australia. Strodl, E., Shakespeare-Finch, J., Alichniewicz, KK., et al.[2022]

Routine screening for distress in cancer survivors is increasingly recommended, with the single-item distress thermometer being the preferred tool for identifying patients in need of support.

While screening can improve timely referrals for distress management, challenges remain in delivering effective treatments due to patients declining help and insufficient support services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for distress in survivorship. Girgis, A., Smith, AB., Durcinoska, I.[2019]

The Stress Proffen app-based intervention for cancer survivors showed significant reductions in stress, anxiety, and self-regulatory fatigue, along with improvements in health-related quality of life, based on a pilot study with 25 participants.

Participants found the app to be a valuable and accessible tool for stress management, with 67% completing at least 7 out of 10 modules, indicating good engagement and usability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot testing an app-based stress management intervention for cancer survivors. Børøsund, E., Varsi, C., Clark, MM., et al.[2022]

The Distress Thermometer (DT) is an effective screening tool for detecting psychological issues like anxiety and depression in early cancer survivors, showing high accuracy with an area under the curve of 0.85 to 0.87 in a study of 1,323 participants.

The optimal cut-off score for the DT varies based on its use: a score of ≥2 is best for clinical settings, while ≥4 is more suitable for research, indicating that the DT should be tailored to the context in which it is used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How does the Distress Thermometer compare to the Hospital Anxiety and Depression Scale for detecting possible cases of psychological morbidity among cancer survivors? Boyes, A., D'Este, C., Carey, M., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04058795

NCT04058795 | PTSD Mobile App for Cancer Survivors 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.

2. dailynews.ascopubs.org dailynews.ascopubs.org/do/mobile-app-offers-promising-intervention-ptsd-symptom-relief-cancer-survivors-received

Mobile App Offers Promising Intervention for PTSD ... Stepped-care digital CBT improves symptoms of cancer-related PTSD as soon as 3 months after the intervention among cancer survivors who had ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41116260/?utm_source=FeedFetcher&utm_medium=rss&utm_campaign=None&utm_content=00gajDR9hjYdTQU64HCIKlRKFFlh-oe205V3pjg0iah&fc=None&ff=20251022130636&v=2.18.0.post22+67771e2

A Pilot Study of the Cancer Distress Coach-Caregiver App This pilot study evaluated the feasibility, acceptability, and preliminary efficacy of Cancer Distress Coach-Caregiver (CaDC-C), an app designed ...

4. ascopubs.org ascopubs.org/doi/abs/10.1200/OP.2025.21.10_suppl.550

A digital health approach to improving PTSD symptom ... CaDC is a promising first-line intervention, while CaDC+Coaching and CBT-PTSD offer substantial added benefits for non-responders. These ...

5. researchgate.net researchgate.net/publication/396738102_A_Pilot_Study_of_the_Cancer_Distress_Coach-Caregiver_App_A_Digital_Intervention_for_Reducing_PTSD_Symptoms_in_HCT_Caregivers

A Pilot Study of the Cancer Distress Coach-Caregiver App CaDC‐C participants also demonstrated a significant reduction in anxiety symptoms at Week 4 ( p = 0.02). Discussion This pilot demonstrates the ...

6. withpower.com withpower.com/trial/ptsd-mobile-app-for-cancer-survivors-da906

PTSD Mobile App for Cancer Survivors · Info for Participants The available research does not directly address safety data for the PTSD Mobile App for Cancer Survivors. However, related studies on app-based cognitive- ...

7. play.google.com play.google.com/store/apps/details?id=explorer.pavir.cancerdistresscoach&hl=en_US

Cancer Distress Coach - Apps on Google Play The app provides information, coping skills and tools, an assessment for tracking symptoms over time, and resources for connecting with additional support.

8. dihi.org dihi.org/project/cancer-distress-coach/

Cancer Distress Coach We developed an Android and iOS mobile app, Cancer Distress Coach, to help users manage their symptoms of cancer-related PTSD.

9. mental.jmir.org mental.jmir.org/2022/3/e34744/

PTSD Coach Version 3.1: A Closer Look at the Reach, Use ... Importantly, PTSD Coach is provided free of charge and protects users' privacy by collecting data anonymously (ie, no identifying information).