AI-Powered Support for Cancer

Overseen By Zeina Nahleh, MD, FACP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Stage 4 cancer, Severe psychiatric, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether an AI-powered app (WYSA App) can improve quality of life and reduce anxiety and depression in people with cancer who are already receiving psychotherapy. Participants will divide into two groups: one will use the AI app alongside their usual therapy, while the other will continue their usual therapy without the app. The trial seeks individuals actively treated for stages I-III cancer who experience significant emotional distress and have access to a smartphone. As an unphased trial, this study provides a unique opportunity to explore innovative support options alongside traditional therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on psychotherapy and an AI app, so it's likely you can continue your current cancer treatments.

What prior data suggests that the WYSA App is safe for use in psychotherapy?

Research shows that the Wysa app is generally safe for users. Past studies have used this AI-powered app to help with anxiety and depression, and no major reports of harmful side effects or safety issues have emerged.

Different groups, such as healthcare workers, have tested the app, and it has been well-received. Safety measures protect users' data and privacy. Overall, the Wysa app appears to be a safe choice for those seeking to improve their mental health while receiving cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the WYSA App for cancer support because it leverages AI technology to provide personalized mental health support. Unlike traditional psychotherapy, which relies solely on therapist interactions, the WYSA App offers 24/7 assistance through an AI chatbot, potentially enhancing accessibility and consistency in care. This innovative approach could revolutionize mental health support for cancer patients by offering immediate, on-demand emotional assistance, complementing standard psychotherapy sessions.

What evidence suggests that the WYSA App is effective for improving quality of life, anxiety, and depression in cancer patients?

Research has shown that the Wysa app, which participants in this trial may use alongside psychotherapy, can help reduce anxiety and depression. One study found that people using the app felt less anxious and depressed. Another study demonstrated that mental health chatbots, like Wysa, provide valuable support to people with long-term illnesses, improving their emotional well-being. Real-world data also indicates that people actively use the Wysa app, suggesting it aids in managing mental health. Overall, the evidence supports Wysa as a useful tool for improving mental well-being. ^{1 3 5 6 7}

Who Is on the Research Team?

Zeina Nahleh, MD, FACP

Principal Investigator

Case Comprehensive Cancer Center, Cleveland Clinic Florida

Are You a Good Fit for This Trial?

This trial is for cancer patients undergoing treatment who might benefit from psychotherapy. It's designed to see if an AI-powered app can improve their quality of life, anxiety, and depression alongside standard therapy.

Inclusion Criteria

Participants who are willing and able to provide informed consent

Participants followed by a medical oncologist, radiation oncologist, and/or surgical oncologist at Cleveland Clinic Florida with no barrier to receive psychotherapy care

I am 18 years old or older.

Exclusion Criteria

Concurrent enrollment in another trial targeting psychological distress

Participants with active severe psychiatric conditions identified by the Cleveland Clinic psychotherapist

Limited life expectancy (<3 months) as determined by the oncologist

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive psychotherapy with or without the AI-powered app to improve quality of life, anxiety, and depression symptoms

12 weeks

Regular psychotherapy visits

Follow-up

Participants are monitored for changes in quality of life, anxiety, and depression symptoms after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• WYSA App

Trial Overview The study compares two groups: one receives usual psychotherapy plus access to the WYSA App—an AI tool aimed at supporting mental health—and the other group only gets standard psychotherapy without the app.

How Is the Trial Designed?

Group I: Psychotherapy + WYSA App Experimental Treatment 2 Interventions

Group II: Standard of Care Psychotherapy Active Control 1 Intervention

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Florida Department of Health (Casey DeSantis Florida Cancer Innovation Fund)

Collaborator

Citations

1. mhealth.jmir.org mhealth.jmir.org/2018/11/e12106/

Real-World Data Evaluation Mixed-Methods Study Conclusions: The real-world data evaluation findings on the effectiveness and engagement levels of Wysa app on users with self-reported symptoms ...

2. blogs.wysa.io blogs.wysa.io/wp-content/uploads/2023/11/Wysa-Bibliography-1.pdf

Wysa Bibliography The real-world data evaluation findings on the effectiveness and engagement levels of Wysa app on users with self-reported symptoms of depression show ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05533190

Study Details | NCT05533190 | Clinical Investigation of Wysa This project aims to examine the impact of using Wysa on patients' symptoms of anxiety and depression during the referral process for standard UK mental health ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11701045/

Examining a brief web and longitudinal app-based ... This study explores the potential benefits of offering a digital mental health intervention (DMHI), Wysa, as a brief and longitudinal intervention.

5. sciencedirect.com sciencedirect.com/org/science/article/pii/S2561326X24003160

Effectiveness of a Mental Health Chatbot for People With ... The results of this study suggest that mental health chatbots can be an effective source of mental health support for people with chronic diseases such as ...

6. formative.jmir.org formative.jmir.org/2024/1/e51858

AI-Led Mental Health Support (Wysa) for Health Care Workers ... This study explores the feasibility of using Wysa, an artificial intelligence–led mental health app, among health care workers.

7. wysa.com wysa.com/faq

FAQ - AI chatbot | Online Therapy We have put in place a number of safety and security guardrails to protect your data when shared with external LLMs. Your conversations shared with external ...