Colon CancerADOPTRNCT04088955
A Digimed Oncology PharmacoTherapy Registry
An observational study of Colon Cancer and Breast Cancer, run by Proteus Digital Health, Inc. at 1 site in United States.
Trial summary
DigiMeds™ are medications with FDA-approved ingestible sensors (IS), a wearable sensor patch (patch), and a mobile app, which records time-stamped medication type and dose alongside biometric activity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer, Breast Cancer, Rectal Cancer
- What is being tested?
- DigiMeds
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2019to Mar 2022
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals diagnosed with colon, rectal, or breast cancer and diagnosed therapy with capecitabine.
Who may be able to join
- Age ≥ 18
- Prescribed treatment with DigiMeds™
- Have an Android or iOS-enabled device (e.g., iPhone, iPad, Samsung) or be willing to use a Proteus issued iOS device
- Signed consent form
Who cannot join
- Receiving palliative or hospice care services (i.e., proxy for <12 months life expectancy)
- Not proficient in the English language
- Have impaired cognitive ability
- For women: current pregnancy
- Have skin sensitivity to adhesives or active/chronic dermatitis
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolina Blood and Cancer Care
Rock Hill, South Carolina, 29732
About this study
Official title: A Pragmatic, Non-Interventional Study of DigiMeds™ in Combination With Standard of Care for Treatment of Patients With Cancer
DigiMeds™ are medications with FDA-approved ingestible sensors (IS), a wearable sensor patch (patch), and a mobile app, which records time-stamped medication type and dose alongside biometric activity.
The aim of this registry is to collect and analyze data on the use of DigiMeds™ and a digital feedback system on medication adherence, patient-provider communication, and data-driven optimization of therapy for cancer patients.
Read the detailed description
Patients will be prescribed the DMP and DigiMeds™ (capecitabine or supportive medications) by their healthcare provider. The pharmacy will co-encapsulate the prescribed medication with a sensor.
The actual doses of DigiMeds™ will be based on standard of care as prescribed by treating physician. Patients will be instructed in the use of the DigiMeds™ and the DMP based on standard of care plus use of the DMP system.
Every effort should be made to take the DigiMeds™ as prescribed.
Patients in this study will be given the option to use their personal smartphone or will be provided a provisioned iPad to use for the duration of the study. Each patient will receive a Starter Kit comprised of two wearable sensor pods, adhesive strips, and instructions. Additionally, some kits may contain the provisional iPad Mini and charger for those without an approved smart device. Should a device malfunction occur, such as a broken pod, the patient can replace it with their spare pod. Broken pods should be returned to Proteus as soon as possible and all pods must be returned to the clinic upon completion of the study.
- Conditions
- Colon Cancer, Breast Cancer, Rectal Cancer
- Being tested
- DigiMeds
- Keywords
- DigiMeds, Capecitabine, Standard of Care
- Medical subject headings
- Colonic Neoplasms, Breast Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DigiMedsOther
Digitized Capecitabine
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the duration of actual vs. intended treatment for cancer patients on capecitabine who are prescribed capecitabine with sensor.
Determine how long patients can stay on treatment when using DigiMeds
Measured: Up to 6 months from the date of inclusion into study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start6 Sep 2019
- Primary completionSep 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Proteus Digital Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sinette Heys, Study director, Proteus Digital Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088955
- Sponsor's protocol ID
- PRO 1676
- Acronym
- ADOPTR
- Status last verified
- Sep 2019
- First submitted
- 10 Sep 2019
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- 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 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic, Non-Interventional Study of DigiMeds™ in Combination With Standard of Care for Treatment of Patients With Cancer
- ClinicalTrials.gov ID
- NCT04088955
- Acronym / sponsor ID
- ADOPTR / PRO 1676
- Conditions
- Colon Cancer, Breast Cancer, Rectal Cancer
- Keywords
- DigiMeds, Capecitabine, Standard of Care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Proteus Digital Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Sep 2019 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 13 Sep 2019 (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.
DigiMeds™ are medications with FDA-approved ingestible sensors (IS), a wearable sensor patch (patch), and a mobile app, which records time-stamped medication type and dose alongside biometric activity.
The aim of this registry is to collect and analyze data on the use of DigiMeds™ and a digital feedback system on medication adherence, patient-provider communication, and data-driven optimization of therapy for cancer patients.
Detailed description
Patients will be prescribed the DMP and DigiMeds™ (capecitabine or supportive medications) by their healthcare provider. The pharmacy will co-encapsulate the prescribed medication with a sensor.
The actual doses of DigiMeds™ will be based on standard of care as prescribed by treating physician. Patients will be instructed in the use of the DigiMeds™ and the DMP based on standard of care plus use of the DMP system.
Every effort should be made to take the DigiMeds™ as prescribed.
Patients in this study will be given the option to use their personal smartphone or will be provided a provisioned iPad to use for the duration of the study. Each patient will receive a Starter Kit comprised of two wearable sensor pods, adhesive strips, and instructions. Additionally, some kits may contain the provisional iPad Mini and charger for those without an approved smart device. Should a device malfunction occur, such as a broken pod, the patient can replace it with their spare pod. Broken pods should be returned to Proteus as soon as possible and all pods must be returned to the clinic upon completion of the study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals diagnosed with colon, rectal, or breast cancer and diagnosed therapy with capecitabine.
Key inclusion criteria (4 listed)
- Age ≥ 18
- Prescribed treatment with DigiMeds™
- Have an Android or iOS-enabled device (e.g., iPhone, iPad, Samsung) or be willing to use a Proteus issued iOS device
- Signed consent form
Key exclusion criteria (5 listed)
- Receiving palliative or hospice care services (i.e., proxy for <12 months life expectancy)
- Not proficient in the English language
- Have impaired cognitive ability
- For women: current pregnancy
- Have skin sensitivity to adhesives or active/chronic dermatitis
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 |
|---|---|---|
| DigiMedsDigitized Capecitabine | Other | – |
Primary outcome
Compare the duration of actual vs. intended treatment for cancer patients on capecitabine who are prescribed capecitabine with sensor.
Time frame: Up to 6 months from the date of inclusion into study
Determine how long patients can stay on treatment when using DigiMeds
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- 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.
Sinette Heys study director
Proteus Digital Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Breast Cancer, run by Proteus Digital Health, Inc. 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 Mar 2020. 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?
Results are not available in the source record.
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?
Compare the duration of actual vs. intended treatment for cancer patients on capecitabine who are prescribed capecitabine with sensor. (time frame: Up to 6 months from the date of inclusion into study). 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 11 Mar 2020.