Gastrointestinal CancerNCT05113264
'Penny', a SMS Text-based Chatbot Intervention for Medication Adherence and Side Effect Management Among Patients With GI Cancers
A study testing 'Penny' via Memora Platform in people with Gastrointestinal Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer
- What is being tested?
- 'Penny' via Memora Platform
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2021to 8 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
About this study
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
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.
Read more
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
- Being tested
- 'Penny' via Memora Platform
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'Penny' via Memora PlatformDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Penny, a SMS Text-based chatbot intervention | Experimental | This is a single arm study. All recruited patients will be entered on the Penny SMS Text-based chatbot intervention. Receives: Device: 'Penny' via Memora Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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
Measured: 12 month
Medication Compliance - Will assess accuracy of medication reminders to patients and patient adherence to prescribed medication dosing and schedule
Over an approximate three-month treatment period, Penny will guide patients through when and how to take their oral chemotherapies as well as any supportive medications designed to improve regimen compliance. Penny will text patient to walk them through what medications to take, how to take them and any other supplemental pieces involved with their medication regimen based on specified instructions outlined by their providers, i.e. specific timing of medications in relation to meals. After the three-month treatment period, medication compliance will be assessed by looking at how many times the patient responds 'taken' after begin prompted with a medication reminder.
Measured: 12 months
Patient Engagement with the Penny chatbot
The intervention will be measured longitudinally by patient engagement with Penny using a threshold of 80%. That number will be calculated by the following formula: Number of patient responses within two hours of Penny initiating a conversation divided by the total number times Penny initiates a conversation.
Measured: 12 months
Secondary outcomes (1)
Patient Satisfaction with the Penny chatbot interactions will be measured by the Promoter Score
In order to quantify this, we will ask every patient using Penny to grade their experience using Penny utilizing the Net Promoter Score (NPS). This will be completed at the end of their three-month enrollment period.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start2 Aug 2021
- Primary completion5 Nov 2024
- Study completion8 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113264
- Sponsor's protocol ID
- UPCC 25218
- Status last verified
- Dec 2024
- First submitted
- 19 Oct 2021
- Last updated
- 17 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05113264
- Acronym / sponsor ID
- UPCC 25218
- Conditions
- Gastrointestinal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 5 Nov 2024 (actual)
- Study completion
- 8 Nov 2024 (actual)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Penny, a SMS Text-based chatbot intervention | Experimental | Device: 'Penny' via Memora PlatformThis is a single arm study. All recruited patients will be entered on the Penny SMS Text-based chatbot intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults (age >18 years) with a diagnosis of a GI cancer, that is receiving one of the below treatments:
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 'Penny' via Memora PlatformThe 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. | Device | Penny, a SMS Text-based chatbot intervention |
Primary outcome
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.
Time frame: 12 month
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
Medication Compliance - Will assess accuracy of medication reminders to patients and patient adherence to prescribed medication dosing and schedule
Time frame: 12 months
Over an approximate three-month treatment period, Penny will guide patients through when and how to take their oral chemotherapies as well as any supportive medications designed to improve regimen compliance. Penny will text patient to walk them through what medications to take, how to take them and any other supplemental pieces involved with their medication regimen based on specified instructions outlined by their providers, i.e. specific timing of medications in relation to meals. After the three-month treatment period, medication compliance will be assessed by looking at how many times the patient responds 'taken' after begin prompted with a medication reminder.
Patient Engagement with the Penny chatbot
Time frame: 12 months
The intervention will be measured longitudinally by patient engagement with Penny using a threshold of 80%. That number will be calculated by the following formula: Number of patient responses within two hours of Penny initiating a conversation divided by the total number times Penny initiates a conversation.
1 secondary outcome
Patient Satisfaction with the Penny chatbot interactions will be measured by the Promoter Score
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 'Penny' via Memora Platform in people with Gastrointestinal Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 12 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.