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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | Participants will have a diagnosis of breast cancer and will be taking Palbociclib. Participants will receive standard of care |
|
| Standard of Care + Intervention | Experimental | Participants will have a diagnosis of breast cancer and will be taking Palbociclib. Participants will receive standard of care + unidirectional text messaging intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paper Drug Diary | Other | Participants will receive and use a paper Drug Diary and a paper medication calendar. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Barton-Burke, PhD, RN | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | Basking Ridge | New Jersey | 07920 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39697813 | Derived | Mazzella-Ebstein A, Barton-Burke M, Anthony V, White C, Zhang Z, Smith A, Robson M. Oral self-management of palbociclib using mobile technology: Findings from a nurse-led randomized controlled trial. Asia Pac J Oncol Nurs. 2024 Oct 15;11(12):100604. doi: 10.1016/j.apjon.2024.100604. eCollection 2024 Dec. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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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.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| OhMD APP | Other | Participants will receive multiple text messages regarding administration over time on medication self-management over the course of 3 cycles of medication |
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| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) |
| Middletown |
| New Jersey |
| 07748 |
| United States |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Montvale | New Jersey | 07645 | United States |
| Memorial Sloan Kettering Commack (Limited Protocol Activities) | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Nassau (Limited protocol activities) | Rockville Centre | New York | 11553 | United States |
| D017437 |
| Skin and Connective Tissue Diseases |