A Study of the Use of Text Message Reminders to Take Palbociclib

Study Overview
=================
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.

Official Title
-----------------
Oral Self-Management of Palbociclib (Ibrance®) Using Mobile Technology

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: Paper Drug Diary
* Other: OhMD APP


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>Participants will have a diagnosis of breast cancer and will be taking Palbociclib. Participants will receive standard of care | Other: Paper Drug Diary<br>* Participants will receive and use a paper Drug Diary and a paper medication calendar.<br>|
| Experimental: Standard of Care + Intervention<br>Participants will have a diagnosis of breast cancer and will be taking Palbociclib. Participants will receive standard of care + unidirectional text messaging intervention | Other: OhMD APP<br>* Participants will receive multiple text messages regarding administration over time on medication self-management over the course of 3 cycles of medication<br>* Other names: Unidirectional text messaging;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, Palbociclib, Memorial Sloan Kettering Cancer Center, 19-458