Clinical trial NCT05318027: ChatBot and Activity Monitoring in Patients Undergoing Chemoradiotherapy
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Gastrointestinal Cancer
Head and Neck Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


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

Primary outcomes:
measure: Number of triage visits
timeFrame: 13 weeks
Secondary outcomes:
measure: Count of unplanned inpatient hospitalization
timeFrame: 13 weeks
measure: Count of treatment breaks
timeFrame: 13 weeks
measure: Count of emergency department visits
timeFrame: 13 weeks
measure: Quality of Life scores
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Arun Goel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Kristine Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Nishant Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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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.
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.
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.