NCT05113264

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

Completed NA Last updated 17 December 2024

What this trial tests

NA trial testing 'Penny' via Memora Platform in Gastrointestinal Cancer in 60 participants. Completed in 8 November 2024.

Timeline

2 August 2021

Primary endpoint
5 November 2024

8 November 2024

Quick facts

Lead sponsor	Abramson Cancer Center at Penn Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	60
Start date	2 August 2021
Primary completion	5 November 2024
Estimated completion	8 November 2024
Sites	1 location across United States

Drugs / interventions tested

• 'Penny' via Memora Platform

Conditions studied

• Gastrointestinal Cancer — all drugs for Gastrointestinal Cancer →

Sponsor

Abramson Cancer Center at Penn Medicine — full company profile →

Who can join

18 and older, any sex, with Gastrointestinal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Artificial Intelligence in Oncology: A 10-Year ClinicalTrials.gov-Based Analysis Across the Cancer Control Continuum.
   Verma H, Mistry S, Jayam KV, Shrestha P, et al · · 2025 · PMID 41228330 · DOI 10.3390/cancers17213537