ChatBot and Activity Monitoring in Patients Undergoing Chemoradiotherapy

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05318027
• Other study ID #: UPCC 18921
• Status: Recruiting
• Phase: N/A
• Start date: May 22, 2023
• Est. completion date: May 2025

Study information

• Verified date: March 2024
• Source: Abramson Cancer Center at Penn Medicine
• Contact: Michell Kim
• Phone: 215-760-2487
• Email: Michell.Kim[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 changes in activity and early symptom management to emergency department visits, unplanned inpatient hospitalizations and treatment breaks

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Head and Neck Cancer
• Lung Cancer

Intervention

Device:
• ChatBot
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.

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of triage visits	Difference between Poisson event rates of triage visits between intervention and control arms	13 weeks
Secondary	Count of unplanned inpatient hospitalization		13 weeks
Secondary	Count of treatment breaks		13 weeks
Secondary	Count of emergency department visits		13 weeks
Secondary	Quality of Life scores		13 weeks