Clinical trial NCT05113264: 'Penny', a SMS Text-based Chatbot Intervention for Medication Adherence and Side Effect Management Among Patients With GI Cancers
Official title: A Feasibility Study of Electronic Medication Adherence Reminders and Side Effect Management by an Artificial Intelligence ChatBot Via Mobiles Phones Among Patients With Gastrointestinal Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: There has been a dramatic paradigm shift over the last 25 years within cancer care due to the onset of many new targeted therapies and a transition from inpatient to outpatient care. Hand in hand with this shift has been the increased development and use of oral anti-cancer drugs, including cytotoxic chemotherapies that patients self-administer at home versus administration of an intravenous product at an infusion center. One of the main drivers for the growth and popularity of oral chemotherapy has been patient preference. However, an incorrect assumption exists among patients that oral therapy is associated with minimal side effects. According to the 2008 NCCN Task Force Report on Oral Chemotherapy, "some patients may incorrectly assume that oral chemotherapy is not "real" chemotherapy and is more akin to taking a vitamin or antibiotic. Furthermore, patients must understand that oral equivalents of cytotoxic therapies, such as capecitabine, have side effects that are similar to their parenteral counterparts in this case, fluorouracil. The need to monitor for side effects and titrate dosages increases the complexity of oral chemotherapy regimens".

Self-administration of these complex oral therapies causes patients to become more autonomous in their care, without medical supervision of doses between office visits. Due to the lack of oversight, there is a concern of compromised efficacy if patients take less than the prescribed doses, or increased, sometimes life-threatening, toxicity, often between office visits, if more than the prescribed dose is taken. Both daily dose and schedule can be complicated for patients to comprehend and follow.

Capecitabine is a particularly complex oral chemotherapy, with 2 pill dose sizes, dosing by Body Surface Area (BSA), twice a day dosing, and days of on therapy and days off of therapy. For this reason, capecitabine has been chosen as the backbone for regimens that will be studied. As noted in section 5.3 capecitabine might be combined with other oral chemotherapies, Parenteral chemotherapy or radiation therapy.

The investigators believe there is an opportunity in this space to improve oral chemotherapy adherence by walking patients through how and when to take their oral therapies remotely, as well as to better manage toxicity by gathering more information from the patient during their treatment.


Eligibility criteria: Inclusion Criteria:

* Adults (age \>18 years) with a diagnosis of a GI cancer, that is receiving one of the below treatments:

  * Capecitabine ONLY
  * Capecitabine concurrent with Radiation Therapy
  * Capecitabine with Temozolomide
  * Capecitabine with Oxaliplatin
  * Capecitabine with Mitomycin and concurrent Radiation Therapy

Exclusion Criteria:

-

Primary outcomes:
measure: Patient Safety of the Patient - Penny Chatbot interactions with patients will be assessed for accuracy of medication directions and triaging of symptoms reported and number of incorrect interactions between Penny and Patients will be measured.
timeFrame: 12 month
measure: Medication Compliance - Will assess accuracy of medication reminders to patients and patient adherence to prescribed medication dosing and schedule
timeFrame: 12 months
measure: Patient Engagement with the Penny chatbot
timeFrame: 12 months
Secondary outcomes:
measure: Patient Satisfaction with the Penny chatbot interactions will be measured by the Promoter Score
timeFrame: 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center
state: Pennsylvania
Study officials:
References: