Use of Natural Language Processing ChatBot and Automated Continuous Activity Monitoring Via Mobile Phones for Early Detection and Management of Symptoms in Patients Undergoing Cancer Treatment

AI Chatbot and Activity Tracker for Cancer Patients

NCT: NCT05318027 · Status: ACTIVE NOT RECRUITING · Phase: Phase 2 · Sponsor: Abramson Cancer Center at Penn Medicine · Started: 2023-05-22 · Est. Completion: 2026-12

Plain English Summary

ChatBot and Activity Monitoring in Patients Undergoing Chemoradiotherapy is a Phase 2 clinical trial sponsored by Abramson Cancer Center at Penn Medicine studying Lung Cancer, Gastrointestinal Cancer, Head and Neck Cancer. This study tests if an AI chatbot and a wearable activity tracker can help manage symptoms in cancer patients during treatment. It is for adults with lung, gastrointestinal, or head and neck cancer receiving chemotherapy and radiation. Participants will use a chatbot to report symptoms and wear a device to track activity, with options for remote check-ins. Alternatives include standard care, where patients report symptoms during scheduled visits. The trial aims to enroll 70 participants.

Official Summary

Evaluate the feasibility of using a chatbot combined with continuous activity monitoring to proactively identify, appropriately triage and help manage patients' symptoms during cancer treatment Determine whether such an early outpatient clinic-based intervention can decrease rates of excess triage visits Correlate changes in activity and early symptom management to emergency department visits, unplanned inpatient hospitalizations and treatment breaks

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults over 18 with lung, GI, or head and neck cancer undergoing chemotherapy and radiation. Must have a smartphone that can receive texts and connect to a FitBit, and be able to read and respond in English. Cannot be completely bed-bound or rely solely on a wheelchair for movement. This trial is studying Lung Cancer, Gastrointestinal Cancer, Head and Neck Cancer, so participants generally need a confirmed diagnosis.

What They're Measuring

The number of times patients need to contact the clinic or go to the emergency room for symptom management will be tracked over 13 weeks to see if the technology helps reduce these visits. The specific primary outcome measures are: Number of triage visits (13 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial aims to improve symptom management for cancer patients by using technology to detect issues early, potentially reducing hospital visits and treatment interruptions. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Lung Cancer, Gastrointestinal Cancer, Head and Neck Cancer, where improved treatment options are needed.

Investor Insight

This trial explores the use of AI and wearable tech in oncology care, a growing area with potential to improve patient outcomes and reduce healthcare costs, indicating a move towards more proactive an Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if this study is right for you and what the potential benefits and risks are. You will use a chatbot to report symptoms and wear a device to track your activity, with potential for remote check-ins. This involves regular communication with the study team via phone or app. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* Adults (age \>18 years) with a diagnosis of a head and neck, lung, gastrointestinal cancer, that are receiving concurrent chemotherapy and radiation treatment.
* Possession of a mobile device that can receive SMS texts and can deliver FitBit data wirelessly
* Ability read and respond in English
* Ability to provide informed consent to participate in the study

Exclusion Criteria:

* Patients who are bed bound at baseline (ECOG 4)
* Patients who rely on a wheelchair for ambulation

Trial Locations

Frequently Asked Questions

What is clinical trial NCT05318027?

NCT05318027 is a Phase 2 INTERVENTIONAL study titled "ChatBot and Activity Monitoring in Patients Undergoing Chemoradiotherapy." It is currently active, not recruiting and is sponsored by Abramson Cancer Center at Penn Medicine. The trial targets enrollment of 70 participants.

What conditions does NCT05318027 study?

This trial investigates treatments for Lung Cancer, Gastrointestinal Cancer, Head and Neck Cancer. The primary condition under study is Lung Cancer.

What treatments are being tested in NCT05318027?

The interventions being studied include: ChatBot (DEVICE). The automated chatbot will check in with the patient on two pre-specified days between scheduled outpatient visits. The chatbot will follow pre-specified symptom algorithms and classify symptoms as requiring high, intermediate and low risk follow ups. High risk symptoms will trigger a same day nursing/physician visit or telemedicine call/video. Intermediate risk symptoms will trigger a nursing triage visit or telemedicine call/video on the next day or treatment day. Low risk symptoms will notify

What does Phase 2 mean for NCT05318027?

Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.

What is the current status of NCT05318027?

This trial is currently "Active, Not Recruiting." It started on 2023-05-22. The estimated completion date is 2026-12.

Who is sponsoring NCT05318027?

NCT05318027 is sponsored by Abramson Cancer Center at Penn Medicine. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT05318027?

The trial aims to enroll 70 participants. The trial status is active, not recruiting.

How is NCT05318027 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.

What are the primary outcomes being measured in NCT05318027?

The primary outcome measures are: Number of triage visits (13 weeks). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT05318027 being conducted?

This trial is being conducted at 1 site, including Philadelphia, Pennsylvania (United States).

Where can I find official information about NCT05318027?

The official record for NCT05318027 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05318027. This government database provides the most up-to-date and detailed information about the trial.

What is NCT05318027 testing in simple terms?

This study tests if an AI chatbot and a wearable activity tracker can help manage symptoms in cancer patients during treatment. It is for adults with lung, gastrointestinal, or head and neck cancer receiving chemotherapy and radiation.

Why is this trial significant?

This trial aims to improve symptom management for cancer patients by using technology to detect issues early, potentially reducing hospital visits and treatment interruptions.

What are the potential risks of participating in NCT05318027?

Potential for technology issues or misinterpretation of symptoms by the chatbot. Privacy concerns regarding health data collection. The chatbot may not capture all nuances of a patient's condition, requiring careful follow-up. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT05318027?

Ask your doctor if this study is right for you and what the potential benefits and risks are. You will use a chatbot to report symptoms and wear a device to track your activity, with potential for remote check-ins. This involves regular communication with the study team via phone or app. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT05318027 signal from an investment perspective?

This trial explores the use of AI and wearable tech in oncology care, a growing area with potential to improve patient outcomes and reduce healthcare costs, indicating a move towards more proactive an This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.

What happens if the treatment in this trial doesn't work?

Participants will use a chatbot to report symptoms and wear a device to track activity, with options for remote check-ins. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.