- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02833246
Using a Patient-Centered mHealth Intervention to Improve Adherence to Oral Anticancer Medications
November 16, 2018 updated by: Memorial Sloan Kettering Cancer Center
This study is being done to determine if sending reminder text messages helps patients take their Oral Anticancer Medication (OAMs) when they are supposed to.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient in the Sarcoma, Solid Tumor Gastrointestinal (ST GI), and Thoracic Medicine service at MSK.
- Starting a new treatment regimen that includes a single oral anticancer medication
- Patients must have a mobile phone that can send and receive SMS/MMS messages and is internet-enabled.
- Age 18 or older.
- Ability to speak and read English because we do not have the resources to translate the text messages into other languages.
Exclusion Criteria:
- Patient expresses inability or unfamiliarity with using SMS/MMS messaging on their phone and is unwilling to be trained in the use of this technology.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SMS/MMS text messaging
Patients will be able to tailor their SMS/MMS reminders with respect to when (i.e., what time of day) they wish to receive the reminders, as well as how often the messages are sent (e.g., morning and evening).
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text messaging reminders on oral chemotherapy medication adherence
|
Active Comparator: usual care
This includes physician and nursing assessment and intervention for any identified AEs.
Of note, there is not currently standard follow-up that patients receive from nursing or physician staff while on an OAM treatment.
Patients are encouraged to call their physician's office with any questions or changes in their medical status but are not called routinely by MSK staff.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
objective pill count
Time Frame: 1 year
|
is greater or less than the amount of OAM that the patient should have in their possession.
|
1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Thomas Atkinson, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 28, 2016
Primary Completion (Actual)
November 14, 2018
Study Completion (Actual)
November 14, 2018
Study Registration Dates
First Submitted
July 12, 2016
First Submitted That Met QC Criteria
July 12, 2016
First Posted (Estimate)
July 14, 2016
Study Record Updates
Last Update Posted (Actual)
November 19, 2018
Last Update Submitted That Met QC Criteria
November 16, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-810
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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