A Study of the Use of Text Message Reminders to Take Palbociclib
Oral Self-Management of Palbociclib (Ibrance®) Using Mobile Technology
1 other identifier
interventional
45
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable breast-cancer
Started Dec 2019
Longer than P75 for not_applicable breast-cancer
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 27, 2019
CompletedFirst Submitted
Initial submission to the registry
December 30, 2019
CompletedFirst Posted
Study publicly available on registry
January 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 27, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 27, 2026
March 27, 2026
March 1, 2026
7 years
December 30, 2019
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Accuracy rate of medication self-administration
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
Study Arms (2)
Standard of Care
ACTIVE COMPARATORParticipants will have a diagnosis of breast cancer and will be taking Palbociclib. Participants will receive standard of care
Standard of Care + Intervention
EXPERIMENTALParticipants will have a diagnosis of breast cancer and will be taking Palbociclib. Participants will receive standard of care + unidirectional text messaging intervention
Interventions
Participants will receive and use a paper Drug Diary and a paper medication calendar.
Participants will receive multiple text messages regarding administration over time on medication self-management over the course of 3 cycles of medication
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- History of taking palbociclib (Ibrance)
- Patients whose caregivers coordinate their health care
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited protocol activities)
Rockville Centre, New York, 11553, United States
Related Publications (1)
Mazzella-Ebstein A, Barton-Burke M, Anthony V, White C, Zhang Z, Smith A, Robson M. Oral self-management of palbociclib using mobile technology: Findings from a nurse-led randomized controlled trial. Asia Pac J Oncol Nurs. 2024 Oct 15;11(12):100604. doi: 10.1016/j.apjon.2024.100604. eCollection 2024 Dec.
PMID: 39697813DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Margaret Barton-Burke, PhD, RN
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2019
First Posted
January 2, 2020
Study Start
December 27, 2019
Primary Completion (Estimated)
December 27, 2026
Study Completion (Estimated)
December 27, 2026
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
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.