Clinical trial · Interventional
'Penny', a SMS Text-based Chatbot Intervention for Medication Adherence and Side Effect Management Among Patients With GI Cancers
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 'Penny' via Memora Platform | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Penny, a SMS Text-based chatbot intervention
- description
- This is a single arm study. All recruited patients will be entered on the Penny SMS Text-based chatbot intervention.
- interventionNames
- Device: 'Penny' via Memora Platform
Primary outcomes (3)
- 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
- description
- Penny will triage patient-reported side effects based on CTCAE guidelines. If the side effect is determined to be a grade one or two, patients will be walked through self-care by the bot utilizing pre-determined algorithms. If the side effect is deemed grade three or higher or if the chatbot does not recognize the symptom to triage, an Epic inbox message will trigger to the patients care team to follow-up directly with the patient. While the chatbot will be responding independently, members of the investigative team will monitor and audit ALL conversations between the patient and Penny to validate its safety, track for any information that may be relayed to the patient incorrectly and intervene upon these events to guarantee patient safety
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: \-
References
Publications (0)
Data not yet available