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Lung CancerPhase 2NCT05318027

ChatBot and Activity Monitoring in Patients Undergoing Chemoradiotherapy

A Phase 2 study testing ChatBot in people with Lung Cancer and Gastrointestinal Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ChatBot
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteUnited States
Study dates
22 May 2023to Dec 2026
Phase
Phase 2
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

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: 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

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

Being tested
ChatBot
Medical subject headings
Lung Neoplasms, Gastrointestinal Neoplasms, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChatBotDevice

    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 the treating physician to address the symptoms at the next scheduled on treatment visit (OTV). If adjustments are needed in the chat bot triage algorithms, they will be updated in real time to decrease risk for adverse patient events.

Study groups in NCT05318027
Study groupRoleWhat they receive
Activity Monitoring and ChatBotExperimentalPatients will receive standard of care chemotherapy and radiation therapy regimens, activity monitoring and utilize a ChatBot
Receives: Device: ChatBot
Activity Monitoring without ChatBotNo interventionPatients will receive standard of care chemotherapy and radiation therapy regimens, activity monitoring alone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of triage visits

    Difference between Poisson event rates of triage visits between intervention and control arms

    Measured: 13 weeks

Secondary outcomes (4)

  1. Count of unplanned inpatient hospitalization

    Measured: 13 weeks

  2. Count of treatment breaks

    Measured: 13 weeks

  3. Count of emergency department visits

    Measured: 13 weeks

  4. Quality of Life scores

    Measured: 13 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2022
  2. Study start22 May 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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 2
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05318027
Sponsor's protocol ID
UPCC 18921
Status last verified
Mar 2026
First submitted
6 Dec 2021
Last updated
1 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Uyterlinde W. Overcoming toxicity-challenges in chemoradiation for non-small cell lung cancer. Transl Lung Cancer Res. 2016 Jun;5(3):239-43. doi: 10.21037/tlcr.2016.05.03.

    PubMed 27413701

  • Ghosh S, Rao PB, Kumar PR, Manam S. Concurrent Chemoradiation with Weekly Cisplatin for the Treatment of Head and Neck Cancers: an Institutional Study on Acute Toxicity and Response to Treatment. Asian Pac J Cancer Prev. 2015;16(16):7331-5. doi: 10.7314/apjcp.2015.16.16.7331.

    PubMed 26514533

  • Haj Mohammad N, Hulshof MC, Bergman JJ, Geijsen D, Wilmink JW, van Berge Henegouwen MI, van Laarhoven HW. Acute toxicity of definitive chemoradiation in patients with inoperable or irresectable esophageal carcinoma. BMC Cancer. 2014 Jan 31;14:56. doi: 10.1186/1471-2407-14-56.

    PubMed 24485047

  • Waddle MR, Chen RC, Arastu NH, Green RL, Jackson M, Qaqish BF, Camporeale J, Collichio FA, Marks LB. Unanticipated hospital admissions during or soon after radiation therapy: Incidence and predictive factors. Pract Radiat Oncol. 2015 May-Jun;5(3):e245-e253. doi: 10.1016/j.prro.2014.08.004. Epub 2014 Sep 17.

    PubMed 25413398

  • Auperin A, Le Pechoux C, Rolland E, Curran WJ, Furuse K, Fournel P, Belderbos J, Clamon G, Ulutin HC, Paulus R, Yamanaka T, Bozonnat MC, Uitterhoeve A, Wang X, Stewart L, Arriagada R, Burdett S, Pignon JP. Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer. J Clin Oncol. 2010 May 1;28(13):2181-90. doi: 10.1200/JCO.2009.26.2543. Epub 2010 Mar 29.

    PubMed 20351327

  • Lang K, Sussman M, Friedman M, Su J, Kan HJ, Mauro D, Tafesse E, Menzin J. Incidence and costs of treatment-related complications among patients with advanced squamous cell carcinoma of the head and neck. Arch Otolaryngol Head Neck Surg. 2009 Jun;135(6):582-8. doi: 10.1001/archoto.2009.46.

    PubMed 19528407

  • Beg MS, Gupta A, Stewart T, Rethorst CD. Promise of Wearable Physical Activity Monitors in Oncology Practice. J Oncol Pract. 2017 Feb;13(2):82-89. doi: 10.1200/JOP.2016.016857.

    PubMed 28387544

  • McNeely ML, Campbell KL, Rowe BH, Klassen TP, Mackey JR, Courneya KS. Effects of exercise on breast cancer patients and survivors: a systematic review and meta-analysis. CMAJ. 2006 Jul 4;175(1):34-41. doi: 10.1503/cmaj.051073.

    PubMed 16818906

  • Fu J, Pepin A, Hollawell C, Tang K, Bryer JS, Munter A, Sinha S, Goel A. Digital symptom monitoring and activity tracking in chemoradiation-lessons from the CAM experience. ESMO Real World Data Digit Oncol. 2026 Jan 23;11:100683. doi: 10.1016/j.esmorw.2026.100683. eCollection 2026 Mar.

    PubMed 41930312

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ChatBot in people with Lung Cancer and Gastrointestinal Cancer, run by Abramson Cancer Center at Penn Medicine 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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 1 Apr 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of triage visits (time frame: 13 weeks). 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 NCT05318027, which also lists 9 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 1 Apr 2026.

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