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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04216576
Other study ID # 19-458
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 27, 2019
Est. completion date December 27, 2024

Study information

Verified date January 2024
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 45
Est. completion date December 27, 2024
Est. primary completion date December 27, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Paper Drug Diary
Participants will receive and use a paper Drug Diary and a paper medication calendar.
OhMD APP
Participants will receive multiple text messages regarding administration over time on medication self-management over the course of 3 cycles of medication

Locations

Country Name City State
United States Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) Basking Ridge New Jersey
United States Memorial Sloan Kettering Commack (Limited Protocol Activities) Commack New York
United States Memorial Sloan Kettering Westchester (Limited Protocol Activities) Harrison New York
United States Memorial Sloan Kettering Monmouth (Limited Protocol Activities) Middletown New Jersey
United States Memorial Sloan Kettering Bergen (Limited Protocol Activities) Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York
United States Memorial Sloan Kettering Nassau (Limited protocol activities) Rockville Centre New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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