ChatBot and Activity Monitoring in Patients Undergoing Chemoradiotherapy

NCT05318027 | Active Not Recruiting Phase 2

• 1 other identifier: UPCC 18921
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Lung Cancer; Gastrointestinal Cancer; Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Number of triage visits

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

  13 weeks

Secondary Outcomes (4)

• Count of unplanned inpatient hospitalization

  13 weeks

• Count of treatment breaks

  13 weeks

• Count of emergency department visits

  13 weeks

• Quality of Life scores

  13 weeks

Study Arms (2)

Activity Monitoring and ChatBot

EXPERIMENTAL

Patients will receive standard of care chemotherapy and radiation therapy regimens, activity monitoring and utilize a ChatBot

Device: ChatBot

Activity Monitoring without ChatBot

NO INTERVENTION

Patients will receive standard of care chemotherapy and radiation therapy regimens, activity monitoring alone

Interventions

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 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.

Activity Monitoring and ChatBot

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (8)

• 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.

  PMID: 27413701 BACKGROUND

• 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.

  PMID: 26514533 BACKGROUND

• 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.

  PMID: 24485047 BACKGROUND

• 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.

  PMID: 25413398 BACKGROUND

• 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.

  PMID: 20351327 BACKGROUND

• 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.

  PMID: 19528407 BACKGROUND

• 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.

  PMID: 28387544 BACKGROUND

• 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.

  PMID: 16818906 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms; Gastrointestinal Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Arun Goel, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Kristine Kim, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Nishant Shah, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: April 8, 2022
• Study Start: May 22, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)