Breast Cancer Clinical Trial
Official title:
Oral Self-Management of Palbociclib (Ibrance®) Using Mobile Technology
| Verified date | January 2024 |
| Source | Memorial Sloan Kettering Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Memorial Sloan Kettering Cancer Center |
United States,
| 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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