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'Penny', a SMS Text-based Chatbot Intervention for Medication Adherence and Side Effect Management Among Patients With GI Cancers

NCT05113264 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-12-17

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

'Penny' via Memora Platform

The overall objective of this study is to evaluate the feasibility and safety of a novel SMS text- based intervention of an Algorithmically Driven Augmented Intelligence chatbot, "Penny". This chat bot will walk patients through how and when to take their oral chemotherapies, as well as provide real-time management of side effects Grade II or less, and escalate to the clinical team side effects of Grade III or more, as based on the Common Terminology Criteria for Adverse Events (CTCAE), for patients that have a gastrointestinal (GI) cancer.

Sponsors & Collaborators

  • Abramson Cancer Center at Penn Medicine

    lead OTHER

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-02
Primary Completion
2024-11-05
Completion
2024-11-08

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05113264 on ClinicalTrials.gov