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

Official title

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

Overview

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.

Interventions

• Behavioral Standard of Care Psychotherapy
  Participants will receive six psychotherapy sessions over the course of approximately 3 months.
• Behavioral WYSA App
  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.)

Primary outcome measures

• Change in Quality of Life [Time frame: Baseline, 3 months]

Secondary outcome measures (12)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Cleveland Clinic Florida — Weston

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. PMID 22412146
• 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. PMID 20580201
• Niedzwiedz 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. PMID 31604468
• Zabora 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. PMID 11180574
• Brown 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. PMID 12883115
• Gao 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. PMID 20447824
• Phoosuwan 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. PMID 34950961
• Pinquart 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. PMID 20085667

Identifiers

NCT: NCT07167056 · CASE10Z25

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗