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

Primary Purpose

Breast Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Paper Drug Diary
OhMD APP
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer focused on measuring Breast cancer, Palbociclib, Memorial Sloan Kettering Cancer Center, 19-458

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
  • Memorial Sloan Kettering Commack (Limited Protocol Activities)
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Nassau (Limited protocol activities)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care

Standard of Care + Intervention

Arm Description

Participants will have a diagnosis of breast cancer and will be taking Palbociclib. Participants will receive standard of care

Participants will have a diagnosis of breast cancer and will be taking Palbociclib. Participants will receive standard of care + unidirectional text messaging intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 30, 2019
Last Updated
January 19, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04216576
Brief Title
A Study of the Use of Text Message Reminders to Take Palbociclib
Official Title
Oral Self-Management of Palbociclib (Ibrance®) Using Mobile Technology
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 27, 2019 (Actual)
Primary Completion Date
December 27, 2023 (Anticipated)
Study Completion Date
December 27, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, Palbociclib, Memorial Sloan Kettering Cancer Center, 19-458

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Participants will have a diagnosis of breast cancer and will be taking Palbociclib. Participants will receive standard of care
Arm Title
Standard of Care + Intervention
Arm Type
Experimental
Arm Description
Participants will have a diagnosis of breast cancer and will be taking Palbociclib. Participants will receive standard of care + unidirectional text messaging intervention
Intervention Type
Other
Intervention Name(s)
Paper Drug Diary
Intervention Description
Participants will receive and use a paper Drug Diary and a paper medication calendar.
Intervention Type
Other
Intervention Name(s)
OhMD APP
Other Intervention Name(s)
Unidirectional text messaging
Intervention Description
Participants will receive multiple text messages regarding administration over time on medication self-management over the course of 3 cycles of medication
Primary Outcome Measure Information:
Title
Accuracy rate of medication self-administration
Description
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
Time Frame
Up to 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Barton-Burke, PhD, RN
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
Memorial Sloan Kettering Commack (Limited Protocol Activities)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Nassau (Limited protocol activities)
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11553
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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