No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
60 (estimated)
Sponsor
Case Comprehensive Cancer Center · Other
Who this trial is looking for
This trial is looking for people diagnosed with cancer who are receiving treatment and may benefit from therapy. Participants will either use an AI app for support during their therapy sessions or continue therapy without the app. Both groups will share their experiences through surveys.
Are You a Good Fit for This Trial?
You may be able to join if
I am currently receiving cancer treatment.
I have a distress score of 4 or higher.
I have cancer stages I-III confirmed by a biopsy.
I am 18 years or older.
I can read and understand English and/or Spanish.
I have a smartphone that can use the app or access one daily.
I am willing to provide informed consent.
You may not be able to join if
I am under 18 years old.
I have stage 4 cancer.
I have a severe psychiatric condition that affects my ability to participate.
I have active suicidal thoughts or attempts in the past 6 months.
I have had a psychiatric hospitalization in the past 6 months.
I am enrolled in another trial for psychological distress.
I have a life expectancy of less than 3 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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City
State
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Status
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 routinel…
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.
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