- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04216576
A Study of the Use of Text Message Reminders to Take Palbociclib
January 19, 2024 updated by: Memorial Sloan Kettering Cancer Center
Oral Self-Management of Palbociclib (Ibrance®) Using Mobile Technology
The purpose of this study is to find out whether it is feasible (acceptable to participants) to use a smartphone app to send text message reminders to take palbociclib, and whether these reminders are effective at helping people remember to take palbociclib according to the treatment schedule.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
45
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
-
-
New Jersey
-
Basking Ridge, New Jersey, United States, 07920
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
-
Middletown, New Jersey, United States, 07748
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
-
Montvale, New Jersey, United States, 07645
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)
-
-
New York
-
Commack, New York, United States, 11725
- Memorial Sloan Kettering Commack (Limited Protocol Activities)
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Harrison, New York, United States, 10604
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Rockville Centre, New York, United States, 11553
- Memorial Sloan Kettering Nassau (Limited Protocol Activities)
-
-
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
Description
Inclusion Criteria:
- Patients with a breast cancer diagnosis who are initiating therapy on palbociclib (Ibrance)
- >/= 18 years of age
- Able to speak, read and write English
- Willingness and ability to send and receive text messages with intervention app
- Own a mobile telephone "smartphone" with text messaging capabilities. Only iPhone or Android operating systems support OhMD Application
- Criteria applicable for both Control and Intervention groups
- Flip-phones do not support OhMD Application and thus ineligible to participate
- Initiation palbociclib (Ibrance) for the first time, either as monotherapy or in conjunction with other medication such as Lstrozole (Femara) or Fulvestrant (Faslodex)
Exclusion Criteria:
- History of taking palbociclib (Ibrance)
- Patients whose caregivers coordinate their health care
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 |
---|---|
Active Comparator: Standard of Care
Participants will have a diagnosis of breast cancer and will be taking Palbociclib.
Participants will receive standard of care
|
Participants will receive and use a paper Drug Diary and a paper medication calendar.
|
Experimental: Standard of Care + Intervention
Participants will have a diagnosis of breast cancer and will be taking Palbociclib.
Participants will receive standard of care + unidirectional text messaging intervention
|
Participants will receive multiple text messages regarding administration over time on medication self-management over the course of 3 cycles of medication
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy rate of medication self-administration
Time Frame: Up to 1 year
|
The effectiveness of a mobile technology intervention by calculating the proportion of the number of days that the participant accurately self-administers the medication divided by the number of days the medication should have been taken
|
Up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Margaret Barton-Burke, PhD, RN, 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)
December 27, 2019
Primary Completion (Estimated)
December 27, 2024
Study Completion (Estimated)
December 27, 2024
Study Registration Dates
First Submitted
December 30, 2019
First Submitted That Met QC Criteria
December 30, 2019
First Posted (Actual)
January 2, 2020
Study Record Updates
Last Update Posted (Actual)
January 22, 2024
Last Update Submitted That Met QC Criteria
January 19, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-458
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials.
The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov
when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required.
Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication.
Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals.
Requests may be made to: crdatashare@mskcc.org.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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