Artificial Intelligence-Powered Support For Quality Of Life Improvement In Patients With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Quality of Life
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants in active cancer treatment (receiving chemotherapy, immunotherapy and/or radiation therapy) AND reporting National Comprehensive Cancer Network (NCCN) Distress Thermometer scores ≥
- •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.
排除标准
- •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.
研究组 & 干预措施
Psychotherapy + WYSA App
干预措施: Standard of Care Psychotherapy (Behavioral)
Standard of Care Psychotherapy
干预措施: Standard of Care Psychotherapy (Behavioral)
Psychotherapy + WYSA App
干预措施: WYSA App (Behavioral)
结局指标
主要结局
Change in Quality of Life
时间窗: 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.
次要结局
- Change in Anxiety(Baseline, 3 months)
- Change in Depression(Baseline, 3 months)
- Change in physical functioning(Baseline, 3 months)
- Change in role functioning(Baseline, 3 months)
- Change in emotional functioning(Baseline, 3 months)
- Change in cognitive functioning(Baseline, 3 months)
- Change in social functioning(Baseline, 3 months)
- Change in fatigue(Baseline, 3 months)
- Change in nausea/vomiting(Baseline, 3 months)
- Change in pain(Baseline, 3 months)
- Change in dyspnea(Baseline, 3 months)
- Change in insomnia(Baseline, 3 months)
- Change in appetite loss(Baseline, 3 months)
- Change in constipation(Baseline, 3 months)
- Change in diarrhea(Baseline, 3 months)
- Change in financial difficulties(Baseline, 3 months)
- Engagement, measured by frequency of use of app(Length of participation, up to 3 months)
- Engagement, measured by tool usage in app(Length of participation, up to 3 months)
- Engagement, measured by length of app 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(Baseline, 3 months)
- Change in Quality of Life, according to participant characteristic of gender(Baseline, 3 months)
- Change in Quality of Life, according to participant characteristic of race(Baseline, 3 months)
- Change in Quality of Life, according to participant characteristic of ethnicity(Baseline, 3 months)
- Change in Quality of Life, according to participant characteristic of marital status(Baseline, 3 months)
- Change in Quality of Life, according to participant characteristic of cancer type(Baseline, 3 months)
- Change in Quality of Life, according to participant characteristic of cancer stage(Baseline, 3 months)
- Change in Quality of Life, according to participant characteristic of time since diagnosis(Baseline, 3 months)
- Change in Quality of Life, according to participant characteristic of comorbidities(Baseline, 3 months)
- Change in Quality of Life, according to participant characteristic of insurance status(Baseline, 3 months)
- Change in Quality of Life, according to participant characteristic of in-person vs virtual psychotherapy visit(Baseline, 3 months)
- Change in Quality of Life, according to participant characteristic of current therapy regimen(Baseline, 3 months)
- Change in Quality of Life, according to participant characteristic of current psychiatric medication(Baseline, 3 months)
- Change in Quality of Life, according to participant characteristic of current mental health diagnosis(Baseline, 3 months)
- Change in Quality of Life, according to participant characteristic of number of psycho-oncology visits attended previously(Baseline, 3 months)