CancerNCT07167056
Artificial Intelligence-Powered Support For Quality Of Life Improvement In Participants With Cancer
A study testing WYSA App in people with Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- WYSA App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2025to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic Florida
Weston, Florida, 33331
Zeina Nahleh, MD, FACP, 954-659-5840, nahlehz@ccf.org
Zeina Nahleh, MD, FACP
About this study
Official title: Artificial Intelligence-Powered Support For Quality Of Life Improvement In Patients 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.
Read the detailed description
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.
- Conditions
- Cancer
- Being tested
- Standard of Care Psychotherapy, WYSA App
- Keywords
- Psychotherapy, Mental health, Distress, Stage I Cancer, Stage II Cancer, Stage III Cancer, Chatbot, Artificial Intelligence, AI
- Medical subject headings
- Neoplasms, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care PsychotherapyBehavioural
Participants will receive six psychotherapy sessions over the course of approximately 3 months.
WYSA AppBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Psychotherapy + WYSA App | Experimental | Not described Receives: Behavioral: Standard of Care Psychotherapy; Behavioral: WYSA App |
| Standard of Care Psychotherapy | Active comparator | Not described Receives: Behavioral: Standard of Care Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months
Secondary outcomes (35)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Length of participation, up to 3 months
Incidence of adverse events (AEs)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start17 Nov 2025
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Department of Health (Casey DeSantis Florida Cancer Innovation Fund)
- Responsible party
- Sponsor
- Investigators
- Zeina Nahleh, MD, FACP, Principal investigator, Case Comprehensive Cancer Center, Cleveland Clinic Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167056
- Sponsor's protocol ID
- CASE10Z25
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22412146Kroenke 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.
PubMed 20580201Niedzwiedz CL, Knifton L, Robb KA, Katikireddi SV, Smith DJ. Depression and anxiety among people living with and beyond cancer: a growing clinical and research priority. BMC Cancer. 2019 Oct 11;19(1):943. doi: 10.1186/s12885-019-6181-4.
PubMed 31604468Zabora J, BrintzenhofeSzoc K, Curbow B, Hooker C, Piantadosi S. The prevalence of psychological distress by cancer site. Psychooncology. 2001 Jan-Feb;10(1):19-28. doi: 10.1002/1099-1611(200101/02)10:13.0.co;2-6.
PubMed 11180574Brown KW, Levy AR, Rosberger Z, Edgar L. Psychological distress and cancer survival: a follow-up 10 years after diagnosis. Psychosom Med. 2003 Jul-Aug;65(4):636-43. doi: 10.1097/01.psy.0000077503.96903.a6.
PubMed 12883115Gao W, Bennett MI, Stark D, Murray S, Higginson IJ. Psychological distress in cancer from survivorship to end of life care: prevalence, associated factors and clinical implications. Eur J Cancer. 2010 Jul;46(11):2036-44. doi: 10.1016/j.ejca.2010.03.033. Epub 2010 May 4.
PubMed 20447824Phoosuwan N, Lundberg PC. Psychological distress and health-related quality of life among women with breast cancer: a descriptive cross-sectional study. Support Care Cancer. 2022 Apr;30(4):3177-3186. doi: 10.1007/s00520-021-06763-z. Epub 2021 Dec 23.
PubMed 34950961Pinquart M, Duberstein PR. Depression and cancer mortality: a meta-analysis. Psychol Med. 2010 Nov;40(11):1797-810. doi: 10.1017/S0033291709992285. Epub 2010 Jan 20.
PubMed 20085667Satin JR, Linden W, Phillips MJ. Depression as a predictor of disease progression and mortality in cancer patients: a meta-analysis. Cancer. 2009 Nov 15;115(22):5349-61. doi: 10.1002/cncr.24561.
PubMed 19753617Goyal M, Singh S, Sibinga EM, Gould NF, Rowland-Seymour A, Sharma R, Berger Z, Sleicher D, Maron DD, Shihab HM, Ranasinghe PD, Linn S, Saha S, Bass EB, Haythornthwaite JA. Meditation programs for psychological stress and well-being: a systematic review and meta-analysis. JAMA Intern Med. 2014 Mar;174(3):357-68. doi: 10.1001/jamainternmed.2013.13018.
PubMed 24395196Kubo A, Kurtovich E, McGinnis M, Aghaee S, Altschuler A, Quesenberry C Jr, Kolevska T, Avins AL. A Randomized Controlled Trial of mHealth Mindfulness Intervention for Cancer Patients and Informal Cancer Caregivers: A Feasibility Study Within an Integrated Health Care Delivery System. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419850634. doi: 10.1177/1534735419850634.
PubMed 31092044Lei Chui P, Wai S, Lai LL, See MH, Tan SB. Mindful Breathing: Effects of a Five-Minute Practice on Perceived Stress and Mindfulness Among Patients With Cancer. Clin J Oncol Nurs. 2021 Apr 1;25(2):174-180. doi: 10.1188/21.CJON.174-180.
PubMed 33739333Ngamkham S, Holden JE, Smith EL. A Systematic Review: Mindfulness Intervention for Cancer-Related Pain. Asia Pac J Oncol Nurs. 2019 Apr-Jun;6(2):161-169. doi: 10.4103/apjon.apjon_67_18.
PubMed 30931361Biddell CB, Waters AR, Angove RSM, Gallagher KD, Rosenstein DL, Spees LP, Kent EE, Planey AM, Wheeler SB. Facing financial barriers to healthcare: patient-informed adaptation of a conceptual framework for adults with a history of cancer. Front Psychol. 2023 May 15;14:1178517. doi: 10.3389/fpsyg.2023.1178517. eCollection 2023.
PubMed 37255517Faller H, Schuler M, Richard M, Heckl U, Weis J, Kuffner R. Effects of psycho-oncologic interventions on emotional distress and quality of life in adult patients with cancer: systematic review and meta-analysis. J Clin Oncol. 2013 Feb 20;31(6):782-93. doi: 10.1200/JCO.2011.40.8922. Epub 2013 Jan 14.
PubMed 23319686
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-Powered Support For Quality Of Life Improvement In Patients With Cancer
- ClinicalTrials.gov ID
- NCT07167056
- Acronym / sponsor ID
- CASE10Z25
- Conditions
- Cancer
- Keywords
- Psychotherapy, Mental health, Distress, Stage I Cancer, Stage II Cancer, Stage III Cancer, Chatbot, Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Florida Department of Health (Casey DeSantis Florida Cancer Innovation Fund)
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 11 Sep 2025 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychotherapy + WYSA App | Experimental | Behavioral: Standard of Care Psychotherapy, Behavioral: WYSA App |
| Standard of Care Psychotherapy | Active comparator | Behavioral: Standard of Care Psychotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| Standard of Care PsychotherapyParticipants will receive six psychotherapy sessions over the course of approximately 3 months. | Behavioural | Psychotherapy + WYSA App, Standard of Care Psychotherapy |
| WYSA AppParticipants 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. | Behavioural | Psychotherapy + WYSA App |
Primary outcome
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.
35 secondary outcomes
Change in Anxiety
Time frame: Baseline, 3 months
Change in Depression
Time frame: Baseline, 3 months
Change in physical functioning
Time frame: Baseline, 3 months
Change in role functioning
Time frame: Baseline, 3 months
Change in emotional functioning
Time frame: Baseline, 3 months
Change in cognitive functioning
Time frame: Baseline, 3 months
Change in social functioning
Time frame: Baseline, 3 months
Change in fatigue
Time frame: Baseline, 3 months
Change in nausea/vomiting
Time frame: Baseline, 3 months
Change in pain
Time frame: Baseline, 3 months
Change in dyspnea
Time frame: Baseline, 3 months
Change in insomnia
Time frame: Baseline, 3 months
Change in appetite loss
Time frame: Baseline, 3 months
Change in constipation
Time frame: Baseline, 3 months
Change in diarrhea
Time frame: Baseline, 3 months
Change in financial difficulties
Time frame: Baseline, 3 months
Engagement, measured by frequency of use of app
Time frame: Length of participation, up to 3 months
Engagement, measured by tool usage in app
Time frame: Length of participation, up to 3 months
Engagement, measured by length of app chatbot interaction
Time frame: Length of participation, up to 3 months
Incidence of adverse events (AEs)
Time frame: One month after completion of participation, up to 4 months
Change in Quality of Life, according to number of psychotherapy visits completed
Time frame: Baseline, 3 months
Change in Quality of Life, according to participant characteristic of gender
Time frame: Baseline, 3 months
Change in Quality of Life, according to participant characteristic of race
Time frame: Baseline, 3 months
Change in Quality of Life, according to participant characteristic of ethnicity
Time frame: Baseline, 3 months
Change in Quality of Life, according to participant characteristic of marital status
Time frame: Baseline, 3 months
Change in Quality of Life, according to participant characteristic of cancer type
Time frame: Baseline, 3 months
Change in Quality of Life, according to participant characteristic of cancer stage
Time frame: Baseline, 3 months
Change in Quality of Life, according to participant characteristic of time since diagnosis
Time frame: Baseline, 3 months
Change in Quality of Life, according to participant characteristic of comorbidities
Time frame: Baseline, 3 months
Change in Quality of Life, according to participant characteristic of insurance status
Time frame: Baseline, 3 months
Change in Quality of Life, according to participant characteristic of in-person vs virtual psychotherapy visit
Time frame: Baseline, 3 months
Change in Quality of Life, according to participant characteristic of current therapy regimen
Time frame: Baseline, 3 months
Change in Quality of Life, according to participant characteristic of current psychiatric medication
Time frame: Baseline, 3 months
Change in Quality of Life, according to participant characteristic of current mental health diagnosis
Time frame: Baseline, 3 months
Change in Quality of Life, according to participant characteristic of number of psycho-oncology visits attended previously
Time frame: Baseline, 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Background: PubMed 22412146Carlson 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.
- Background: PubMed 20580201Kroenke 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.
- Background: PubMed 31604468Niedzwiedz CL, Knifton L, Robb KA, Katikireddi SV, Smith DJ. Depression and anxiety among people living with and beyond cancer: a growing clinical and research priority. BMC Cancer. 2019 Oct 11;19(1):943. doi: 10.1186/s12885-019-6181-4.
- Background: PubMed 11180574Zabora J, BrintzenhofeSzoc K, Curbow B, Hooker C, Piantadosi S. The prevalence of psychological distress by cancer site. Psychooncology. 2001 Jan-Feb;10(1):19-28. doi: 10.1002/1099-1611(200101/02)10:13.0.co;2-6.
- Background: PubMed 12883115Brown KW, Levy AR, Rosberger Z, Edgar L. Psychological distress and cancer survival: a follow-up 10 years after diagnosis. Psychosom Med. 2003 Jul-Aug;65(4):636-43. doi: 10.1097/01.psy.0000077503.96903.a6.
- Background: PubMed 20447824Gao W, Bennett MI, Stark D, Murray S, Higginson IJ. Psychological distress in cancer from survivorship to end of life care: prevalence, associated factors and clinical implications. Eur J Cancer. 2010 Jul;46(11):2036-44. doi: 10.1016/j.ejca.2010.03.033. Epub 2010 May 4.
- Background: PubMed 34950961Phoosuwan N, Lundberg PC. Psychological distress and health-related quality of life among women with breast cancer: a descriptive cross-sectional study. Support Care Cancer. 2022 Apr;30(4):3177-3186. doi: 10.1007/s00520-021-06763-z. Epub 2021 Dec 23.
- Background: PubMed 20085667Pinquart M, Duberstein PR. Depression and cancer mortality: a meta-analysis. Psychol Med. 2010 Nov;40(11):1797-810. doi: 10.1017/S0033291709992285. Epub 2010 Jan 20.
- Background: PubMed 19753617Satin JR, Linden W, Phillips MJ. Depression as a predictor of disease progression and mortality in cancer patients: a meta-analysis. Cancer. 2009 Nov 15;115(22):5349-61. doi: 10.1002/cncr.24561.
- Background: PubMed 24395196Goyal M, Singh S, Sibinga EM, Gould NF, Rowland-Seymour A, Sharma R, Berger Z, Sleicher D, Maron DD, Shihab HM, Ranasinghe PD, Linn S, Saha S, Bass EB, Haythornthwaite JA. Meditation programs for psychological stress and well-being: a systematic review and meta-analysis. JAMA Intern Med. 2014 Mar;174(3):357-68. doi: 10.1001/jamainternmed.2013.13018.
- Background: PubMed 31092044Kubo A, Kurtovich E, McGinnis M, Aghaee S, Altschuler A, Quesenberry C Jr, Kolevska T, Avins AL. A Randomized Controlled Trial of mHealth Mindfulness Intervention for Cancer Patients and Informal Cancer Caregivers: A Feasibility Study Within an Integrated Health Care Delivery System. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419850634. doi: 10.1177/1534735419850634.
- Background: PubMed 33739333Lei Chui P, Wai S, Lai LL, See MH, Tan SB. Mindful Breathing: Effects of a Five-Minute Practice on Perceived Stress and Mindfulness Among Patients With Cancer. Clin J Oncol Nurs. 2021 Apr 1;25(2):174-180. doi: 10.1188/21.CJON.174-180.
- 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.
Zeina Nahleh, MD, FACP principal investigator
Case Comprehensive Cancer Center, Cleveland Clinic Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WYSA App in people with Cancer, run by Case Comprehensive Cancer Center at 1 site 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 7 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeina Nahleh, MD, FACP (954-659-5840, nahlehz@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life (time frame: Baseline, 3 months). 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 NCT07167056, which also lists 42 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 15 Sep 2026.