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NCT Number: NCT07167056

Artificial Intelligence-Powered Support For Quality Of Life Improvement In Participants With Cancer

This research study is for people who are diagnosed with cancer and are receiving treatment for cancer who may benefit from psychotherapy. The purpose of the study is to see whether an artificial intelligence (AI) powered application (app) could help improve quality of life, anxiety symptoms, and/or depression symptoms, over the course of psychotherapy sessions. Participants in this study will be randomly assigned to one of two groups. One group will receive psychotherapy per usual care and will receive access to the AI-powered app. The second group will only receive psychotherapy per usual care and will NOT receive access to the AI-powered app. Both groups will complete surveys about their quality of life, anxiety symptoms, and depression symptoms over the course of their psychotherapy visits.

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Key information

Conditions

Cancer Behavior Neoplasms Personal Satisfaction Psychological Well-Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location status: Recruiting

Location contact

Zeina Nahleh, MD, FACP

CONTACT

[email protected]

954-659-5840

Zeina Nahleh, MD, FACP

PRINCIPAL_INVESTIGATOR

About this study

Getting a cancer diagnoses and going through treatment can be difficult and lead to symptoms of distress, like anxiety and depression. Feeling distressed or upset can make people with cancer feel worse and potentially shorten how long they live. Because of this, it is important to address the distress that people with cancer may feel in order to improve their well-being. Treatments that don't use medication, like psychotherapy ("talk therapy), relaxation techniques, and mindfulness, can help reduce distress in people with cancer. However, some people do not have access to these types of things, and mental health care overall can be limited by financial, logistical, and geographical barriers. One solution to these barriers could be artificial intelligence (AI)-powered interventions using mobile applications (apps) on someone's phone. AI tools, like chatbots, can provide personal support. They can use Cognitive Behavioral Therapy (CBT) and mindfulness to provide support. They can also provide tools to track someone's mood. AI tools do not replace a diagnosis from a doctor or treatment from a doctor or other clinical care provider. However, these tools could still support and help to improve someone's mental health and well-being. People who have studied this have found that this day-to-day support has decreased anxiety and depression in the general population. However, the use of AI tools to support mental health in people with cancer is not yet well studied.

WYSA is an AI-powered chatbot that uses evidence-based techniques like Cognitive Behavioral Therapy (CBT) and mindfulness. For the purposes of this study, WYSA will be used in addition to standard of care psychotherapy. WYSA will not replace psychotherapy care in this study, and it will not replace a doctor's advice or diagnoses.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants in active cancer treatment (receiving chemotherapy, immunotherapy and/or radiation therapy) AND reporting National Comprehensive Cancer Network (NCCN) Distress Thermometer scores ≥4. The NCCN Distress Thermometer is a validated, single-item screening tool routinely used in cancer care at Cleveland Clinic Florida to identify individuals experiencing psychological distress. A score of 4 or higher indicates clinically significant distress and serves as the eligibility threshold for enrollment in this study.
  • Participants followed by a medical oncologist, radiation oncologist, and/or surgical oncologist of any subspecialty at Cleveland Clinic Florida and have no barrier to receive psychotherapy care (e.g. no insurance restrictions)
  • Participants with biopsy proven cancer of any type, stages I-III.
  • Adults aged 18 years or older.
  • Able to understand and read English and/or Spanish.
  • Participants who own a smartphone compatible with the mobile app (Android or IOS) or have regular (Daily) access to one.
  • Participants who are willing and able to provide informed consent.

Exclusion criteria

  • Age <18 years.
  • Participants with stage 4 cancer.
  • Participants with active severe psychiatric conditions identified by the Cleveland Clinic psychotherapist as any diagnoses that could significantly impair a participant's ability to engage meaningfully with the intervention or provide informed consent. These include, but are not limited to:
  • Current or recent (within the past 6 months) psychotic disorders (e.g., schizophrenia, schizoaffective disorder)
  • Bipolar disorder in a manic or severe depressive phase
  • Active suicidal ideation with intent or recent suicide attempt (within the past 6 months)
  • Severe cognitive impairment or neurocognitive disorders that compromise comprehension or communication or interferes with chatbot use.
  • Any condition requiring psychiatric hospitalization within the past 6 months
  • Concurrent enrollment in another trial targeting psychological distress to avoid bias.
  • Limited life expectancy (<3 months) as determined by the oncologist.

Treatment and study plan

Standard of Care Psychotherapy

Behavioral

Participants will receive six psychotherapy sessions over the course of approximately 3 months.

WYSA App

Behavioral

Participants will have access to the WYSA mental health support artificial intelligence app over the course of the 3 months that they are participating in psychotherapy sessions per standard of care. The app will contain features intended to manage symptoms of depression and anxiety in individuals with cancer. The app will include an AI-powered chatbot with Cognitive Behavioral Therapy (CBT) and mindfulness techniques, visual progress elements (a progress roadmap, a weekly progress report, etc.), and a customizable tool library. Participants are instructed to use the app whenever they feel like it, if they are in distress, or if the app prompts them to use it. App prompts (notifications) will occur once daily.

Primary outcomes

  1. Change in Quality of Life

    Time frame: Baseline, 3 months

    Quality of life (QoL) is measured by the global health status/QoL subscale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0 questionnaire. The global health status/QoL subscale contains two questions, where participants provide an answer on a 7-point Likert scale from "Very poor" (1) to "Excellent" (7). Higher scores indicate greater global health status/QoL.

Secondary outcomes

  1. Change in Anxiety

    Time frame: Baseline, 3 months

    Anxiety is measured by the Generalized Anxiety Disorder-7 (GAD-7) questionnaire. The questionnaire contains 7 questions asking participants about their anxiety symptoms on a 4-point Likert scale from "Not at all" (0) to "Nearly every day" (3). There is one questions regarding how difficult these symptoms have made daily life, where participants provide an answer on a 4-point scale from "Not difficult at all" to "Extremely difficult." Higher scores indicate greater anxiety symptoms.

  2. Change in Depression

    Time frame: Baseline, 3 months

    Depression is measured by the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 contains 8 questions asking participants about their depression symptoms on a 4-point Likert scale from "Not at all" (0) to "Nearly every day" (3). There is one questions regarding how difficult these symptoms have made daily life, where participants provide an answer on a 4-point scale from "Not difficult at all" to "Extremely difficult." Higher scores indicate greater depression symptoms.

  3. Change in physical functioning

    Time frame: Baseline, 3 months

    Physical functioning is measured by the physical functioning (functional scale) subscale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0 questionnaire. It contains five questions, where participants provide an answer on a 4-point Likert scale from "Not at all" (1) to "Very Much" (4). Higher scores indicate lower physical functioning.

  4. Change in role functioning

    Time frame: Baseline, 3 months

    Role functioning is measured by the role functioning (functional scale) subscale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0 questionnaire. It contains two questions, where participants provide an answer on a 4-point Likert scale from "Not at all" (1) to "Very Much" (4). Higher scores indicate lower role functioning.

  5. Change in emotional functioning

    Time frame: Baseline, 3 months

    Emotional functioning is measured by the emotional functioning (functional scale) subscale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0 questionnaire. It contains four questions, where participants provide an answer on a 4-point Likert scale from "Not at all" (1) to "Very Much" (4). Higher scores indicate lower emotional functioning.

  6. Change in cognitive functioning

    Time frame: Baseline, 3 months

    Cognitive functioning is measured by the cognitive functioning (functional scale) subscale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0 questionnaire. It contains two questions, where participants provide an answer on a 4-point Likert scale from "Not at all" (1) to "Very Much" (4). Higher scores indicate lower cognitive functioning.

  7. Change in social functioning

    Time frame: Baseline, 3 months

    Social functioning is measured by the social functioning (functional scale) subscale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0 questionnaire. It contains two questions, where participants provide an answer on a 4-point Likert scale from "Not at all" (1) to "Very Much" (4). Higher scores indicate lower social functioning.

  8. Change in fatigue

    Time frame: Baseline, 3 months

    Fatigue is measured by the fatigue (symptom scale) subscale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0 questionnaire. It contains three questions, where participants provide an answer on a 4-point Likert scale from "Not at all" (1) to "Very Much" (4). Higher scores indicate greater fatigue symptoms.

  9. Change in nausea/vomiting

    Time frame: Baseline, 3 months

    Nausea/vomiting is measured by the nausea and vomiting (symptom scale) subscale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0 questionnaire. It contains two questions, where participants provide an answer on a 4-point Likert scale from "Not at all" (1) to "Very Much" (4). Higher scores indicate greater fatigue symptoms.

  10. Change in pain

    Time frame: Baseline, 3 months

    Pain is measured by the pain (symptom scale) subscale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0 questionnaire. It contains two questions, where participants provide an answer on a 4-point Likert scale from "Not at all" (1) to "Very Much" (4). Higher scores indicate greater fatigue symptoms.

  11. Change in dyspnea

    Time frame: Baseline, 3 months

    Dyspnea is measured by the dyspnea (symptom item) item of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0 questionnaire. It is one question, where participants provide an answer on a 4-point Likert scale from "Not at all" (1) to "Very Much" (4). Higher scores indicate greater dyspnea symptoms.

  12. Change in insomnia

    Time frame: Baseline, 3 months

    Insomnia is measured by the insomnia (symptom item) item of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0 questionnaire. It is one question, where participants provide an answer on a 4-point Likert scale from "Not at all" (1) to "Very Much" (4). Higher scores indicate greater insomnia symptoms.

  13. Change in appetite loss

    Time frame: Baseline, 3 months

    Appetite loss is measured by the appetite loss (symptom item) item of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0 questionnaire. It is one question, where participants provide an answer on a 4-point Likert scale from "Not at all" (1) to "Very Much" (4). Higher scores indicate greater appetite loss symptoms.

  14. Change in constipation

    Time frame: Baseline, 3 months

    Constipation is measured by the constipation (symptom item) item of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0 questionnaire. It is one question, where participants provide an answer on a 4-point Likert scale from "Not at all" (1) to "Very Much" (4). Higher scores indicate greater constipation symptoms.

  15. Change in diarrhea

    Time frame: Baseline, 3 months

    Diarrhea is measured by the diarrhea (symptom item) item of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0 questionnaire. It is one question, where participants provide an answer on a 4-point Likert scale from "Not at all" (1) to "Very Much" (4). Higher scores indicate greater diarrhea symptoms.

  16. Change in financial difficulties

    Time frame: Baseline, 3 months

    Financial difficulties is measured by the financial difficulties (symptom item) item of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0 questionnaire. It is one question, where participants provide an answer on a 4-point Likert scale from "Not at all" (1) to "Very Much" (4). Higher scores indicate greater financial difficulties.

  17. Engagement, measured by frequency of use of app

    Time frame: Length of participation, up to 3 months

    Frequency will be measured by the amount of times that participants use the app, recorded as the date/time of usage

  18. Engagement, measured by tool usage in app

    Time frame: Length of participation, up to 3 months

    The app contains tools related to mindfulness and Cognitive Behavioral Therapy (CBT)-informed approaches. Engagement is measured by frequency of tool usage.

  19. Engagement, measured by length of app chatbot interaction

    Time frame: Length of participation, up to 3 months

    "Length" is defined as number of messages exchanged during chatbot interaction.

  20. Incidence of adverse events (AEs)

    Time frame: One month after completion of participation, up to 4 months

  21. Change in Quality of Life, according to number of psychotherapy visits completed

    Time frame: Baseline, 3 months

    Quality of life (QoL) is measured by the global health status/QoL subscale of the EORTC QLQ-C30 version 3.0 questionnaire. The global health status/QoL subscale contains two questions, where participants provide an answer on a 7-point Likert scale from "Very poor" (1) to "Excellent" (7). Higher scores indicate greater global health status/QoL.

  22. Change in Quality of Life, according to participant characteristic of gender

    Time frame: Baseline, 3 months

    Quality of life (QoL) is measured by the global health status/QoL subscale of the EORTC QLQ-C30 version 3.0 questionnaire. The global health status/QoL subscale contains two questions, where participants provide an answer on a 7-point Likert scale from "Very poor" (1) to "Excellent" (7). Higher scores indicate greater global health status/QoL.

  23. Change in Quality of Life, according to participant characteristic of race

    Time frame: Baseline, 3 months

    Quality of life (QoL) is measured by the global health status/QoL subscale of the EORTC QLQ-C30 version 3.0 questionnaire. The global health status/QoL subscale contains two questions, where participants provide an answer on a 7-point Likert scale from "Very poor" (1) to "Excellent" (7). Higher scores indicate greater global health status/QoL.

  24. Change in Quality of Life, according to participant characteristic of ethnicity

    Time frame: Baseline, 3 months

    Quality of life (QoL) is measured by the global health status/QoL subscale of the EORTC QLQ-C30 version 3.0 questionnaire. The global health status/QoL subscale contains two questions, where participants provide an answer on a 7-point Likert scale from "Very poor" (1) to "Excellent" (7). Higher scores indicate greater global health status/QoL.

  25. Change in Quality of Life, according to participant characteristic of marital status

    Time frame: Baseline, 3 months

    Quality of life (QoL) is measured by the global health status/QoL subscale of the EORTC QLQ-C30 version 3.0 questionnaire. The global health status/QoL subscale contains two questions, where participants provide an answer on a 7-point Likert scale from "Very poor" (1) to "Excellent" (7). Higher scores indicate greater global health status/QoL.

  26. Change in Quality of Life, according to participant characteristic of cancer type

    Time frame: Baseline, 3 months

    Quality of life (QoL) is measured by the global health status/QoL subscale of the EORTC QLQ-C30 version 3.0 questionnaire. The global health status/QoL subscale contains two questions, where participants provide an answer on a 7-point Likert scale from "Very poor" (1) to "Excellent" (7). Higher scores indicate greater global health status/QoL.

  27. Change in Quality of Life, according to participant characteristic of cancer stage

    Time frame: Baseline, 3 months

    Quality of life (QoL) is measured by the global health status/QoL subscale of the EORTC QLQ-C30 version 3.0 questionnaire. The global health status/QoL subscale contains two questions, where participants provide an answer on a 7-point Likert scale from "Very poor" (1) to "Excellent" (7). Higher scores indicate greater global health status/QoL.

  28. Change in Quality of Life, according to participant characteristic of time since diagnosis

    Time frame: Baseline, 3 months

    Quality of life (QoL) is measured by the global health status/QoL subscale of the EORTC QLQ-C30 version 3.0 questionnaire. The global health status/QoL subscale contains two questions, where participants provide an answer on a 7-point Likert scale from "Very poor" (1) to "Excellent" (7). Higher scores indicate greater global health status/QoL.

  29. Change in Quality of Life, according to participant characteristic of comorbidities

    Time frame: Baseline, 3 months

    Quality of life (QoL) is measured by the global health status/QoL subscale of the EORTC QLQ-C30 version 3.0 questionnaire. The global health status/QoL subscale contains two questions, where participants provide an answer on a 7-point Likert scale from "Very poor" (1) to "Excellent" (7). Higher scores indicate greater global health status/QoL.

  30. Change in Quality of Life, according to participant characteristic of insurance status

    Time frame: Baseline, 3 months

    Quality of life (QoL) is measured by the global health status/QoL subscale of the EORTC QLQ-C30 version 3.0 questionnaire. The global health status/QoL subscale contains two questions, where participants provide an answer on a 7-point Likert scale from "Very poor" (1) to "Excellent" (7). Higher scores indicate greater global health status/QoL.

  31. Change in Quality of Life, according to participant characteristic of in-person vs virtual psychotherapy visit

    Time frame: Baseline, 3 months

    Quality of life (QoL) is measured by the global health status/QoL subscale of the EORTC QLQ-C30 version 3.0 questionnaire. The global health status/QoL subscale contains two questions, where participants provide an answer on a 7-point Likert scale from "Very poor" (1) to "Excellent" (7). Higher scores indicate greater global health status/QoL.

  32. Change in Quality of Life, according to participant characteristic of current therapy regimen

    Time frame: Baseline, 3 months

    Quality of life (QoL) is measured by the global health status/QoL subscale of the EORTC QLQ-C30 version 3.0 questionnaire. The global health status/QoL subscale contains two questions, where participants provide an answer on a 7-point Likert scale from "Very poor" (1) to "Excellent" (7). Higher scores indicate greater global health status/QoL.

  33. Change in Quality of Life, according to participant characteristic of current psychiatric medication

    Time frame: Baseline, 3 months

    Quality of life (QoL) is measured by the global health status/QoL subscale of the EORTC QLQ-C30 version 3.0 questionnaire. The global health status/QoL subscale contains two questions, where participants provide an answer on a 7-point Likert scale from "Very poor" (1) to "Excellent" (7). Higher scores indicate greater global health status/QoL.

  34. Change in Quality of Life, according to participant characteristic of current mental health diagnosis

    Time frame: Baseline, 3 months

    Quality of life (QoL) is measured by the global health status/QoL subscale of the EORTC QLQ-C30 version 3.0 questionnaire. The global health status/QoL subscale contains two questions, where participants provide an answer on a 7-point Likert scale from "Very poor" (1) to "Excellent" (7). Higher scores indicate greater global health status/QoL.

  35. Change in Quality of Life, according to participant characteristic of number of psycho-oncology visits attended previously

    Time frame: Baseline, 3 months

    Quality of life (QoL) is measured by the global health status/QoL subscale of the EORTC QLQ-C30 version 3.0 questionnaire. The global health status/QoL subscale contains two questions, where participants provide an answer on a 7-point Likert scale from "Very poor" (1) to "Excellent" (7). Higher scores indicate greater global health status/QoL.

Study contacts

Contact information is provided by the study sponsor or research team.

Zeina Nahleh, MD, FACP

CONTACT

[email protected]

954-659-5840

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Collaborators

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

Registry information

Official study title

Artificial Intelligence-Powered Support For Quality Of Life Improvement In Patients With Cancer

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 11, 2025
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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