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

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Other: OhMD APP; Other: Paper Drug Diary

• Registration Number: NCT04216576
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-12-27
• Study First Submitted: 2019-12-30
• Study First Submitted QC: 2019-12-30
• Study First Posted: 2020-01-02
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-19
• Last Update Posted: 2024-01-22
• Primary Completion: 2024-12-27
• Study Completion: 2024-12-27

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 45

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)

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Exclusion Criteria

• History of taking palbociclib (Ibrance)
• Patients whose caregivers coordinate their health care

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care + Intervention	OhMD APP	Participants will have a diagnosis of breast cancer and will be taking Palbociclib. Participants will receive standard of care + unidirectional text messaging intervention
Standard of Care	Paper Drug Diary	Participants will have a diagnosis of breast cancer and will be taking Palbociclib. Participants will receive standard of care

Primary Outcome Measures

Name	Time	Method
Accuracy rate of medication self-administration	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

Trial Locations

Locations (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, 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 Commack (Limited Protocol Activities); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Nassau (Limited protocol activities); 🇺🇸 Rockville Centre, New York, United States