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| Name | Class |
|---|---|
| Florida Department of Health (Casey DeSantis Florida Cancer Innovation Fund) | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psychotherapy + WYSA App | Experimental |
| |
| Standard of Care Psychotherapy | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care Psychotherapy | Behavioral | Participants will receive six psychotherapy sessions over the course of approximately 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life | 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. | Baseline, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Anxiety | 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. |
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Inclusion Criteria:
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:
Concurrent enrollment in another trial targeting psychological distress to avoid bias.
Limited life expectancy (<3 months) as determined by the oncologist.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zeina Nahleh, MD, FACP | Contact | 954-659-5840 | nahlehz@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Zeina Nahleh, MD, FACP | Case Comprehensive Cancer Center, Cleveland Clinic Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Florida | Recruiting | Weston | Florida | 33331 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22412146 | Background | Carlson LE, Waller A, Mitchell AJ. Screening for distress and unmet needs in patients with cancer: review and recommendations. J Clin Oncol. 2012 Apr 10;30(11):1160-77. doi: 10.1200/JCO.2011.39.5509. Epub 2012 Mar 12. | |
| 20580201 | Background | Kroenke K, Theobald D, Wu J, Loza JK, Carpenter JS, Tu W. The association of depression and pain with health-related quality of life, disability, and health care use in cancer patients. J Pain Symptom Manage. 2010 Sep;40(3):327-41. doi: 10.1016/j.jpainsymman.2009.12.023. Epub 2010 Jun 26. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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| 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. |
|
| Baseline, 3 months |
| Change in Depression | 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. | Baseline, 3 months |
| Change in physical functioning | 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. | Baseline, 3 months |
| Change in role functioning | 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. | Baseline, 3 months |
| Change in emotional functioning | 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. | Baseline, 3 months |
| Change in cognitive functioning | 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. | Baseline, 3 months |
| Change in social functioning | 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. | Baseline, 3 months |
| Change in fatigue | 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. | Baseline, 3 months |
| Change in nausea/vomiting | 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. | Baseline, 3 months |
| Change in pain | 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. | Baseline, 3 months |
| Change in dyspnea | 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. | Baseline, 3 months |
| Change in insomnia | 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. | Baseline, 3 months |
| Change in appetite loss | 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. | Baseline, 3 months |
| Change in constipation | 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. | Baseline, 3 months |
| Change in diarrhea | 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. | Baseline, 3 months |
| Change in financial difficulties | 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. | Baseline, 3 months |
| Engagement, measured by frequency of use of app | Frequency will be measured by the amount of times that participants use the app, recorded as the date/time of usage | Length of participation, up to 3 months |
| Engagement, measured by tool usage in app | The app contains tools related to mindfulness and Cognitive Behavioral Therapy (CBT)-informed approaches. Engagement is measured by frequency of tool usage. | Length of participation, up to 3 months |
| Engagement, measured by length of app chatbot interaction | "Length" is defined as number of messages exchanged during chatbot interaction. | Length of participation, up to 3 months |
| Incidence of adverse events (AEs) | One month after completion of participation, up to 4 months |
| Change in Quality of Life, according to number of psychotherapy visits completed | 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. | Baseline, 3 months |
| Change in Quality of Life, according to participant characteristic of gender | 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. | Baseline, 3 months |
| Change in Quality of Life, according to participant characteristic of race | 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. | Baseline, 3 months |
| Change in Quality of Life, according to participant characteristic of ethnicity | 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. | Baseline, 3 months |
| Change in Quality of Life, according to participant characteristic of marital status | 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. | Baseline, 3 months |
| Change in Quality of Life, according to participant characteristic of cancer type | 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. | Baseline, 3 months |
| Change in Quality of Life, according to participant characteristic of cancer stage | 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. | Baseline, 3 months |
| Change in Quality of Life, according to participant characteristic of time since diagnosis | 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. | Baseline, 3 months |
| Change in Quality of Life, according to participant characteristic of comorbidities | 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. | Baseline, 3 months |
| Change in Quality of Life, according to participant characteristic of insurance status | 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. | Baseline, 3 months |
| Change in Quality of Life, according to participant characteristic of in-person vs virtual psychotherapy visit | 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. | Baseline, 3 months |
| Change in Quality of Life, according to participant characteristic of current therapy regimen | 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. | Baseline, 3 months |
| Change in Quality of Life, according to participant characteristic of current psychiatric medication | 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. | Baseline, 3 months |
| Change in Quality of Life, according to participant characteristic of current mental health diagnosis | 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. | Baseline, 3 months |
| Change in Quality of Life, according to participant characteristic of number of psycho-oncology visits attended previously | 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. | Baseline, 3 months |
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