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

NCT ID: NCT05113264

Last Updated: 2024-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-02
• Study Completion Date: 2024-11-08

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.

Conditions

Gastrointestinal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Penny, a SMS Text-based chatbot intervention

This is a single arm study. All recruited patients will be entered on the Penny SMS Text-based chatbot intervention.

Group Type: EXPERIMENTAL

'Penny' via Memora Platform

Intervention Type: DEVICE

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.

Interventions

'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.

Intervention Type: DEVICE

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

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

UPCC 25218

Identifier Type: -

Identifier Source: org_study_id