Breast CancerNCT04216576
A Study of the Use of Text Message Reminders to Take Palbociclib
A study testing Paper Drug Diary and OhMD APP in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Paper Drug Diary and OhMD APP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 7 sitesUnited States
- Study dates
- 27 Dec 2019to 27 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- History of taking palbociclib (Ibrance)
- Patients whose caregivers coordinate their health care
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau (Limited protocol activities)
Rockville Centre, New York, 11553
About this study
Official title: Oral Self-Management of Palbociclib (Ibrance®) Using Mobile Technology
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.
- Conditions
- Breast Cancer
- Being tested
- Paper Drug Diary, OhMD APP
- Keywords
- Breast cancer, Palbociclib, Memorial Sloan Kettering Cancer Center, 19-458
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paper Drug DiaryOther
Participants will receive and use a paper Drug Diary and a paper medication calendar.
OhMD APPOther
Also called Unidirectional text messaging
Participants will receive multiple text messages regarding administration over time on medication self-management over the course of 3 cycles of medication
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Participants will have a diagnosis of breast cancer and will be taking Palbociclib. Participants will receive standard of care Receives: Other: Paper Drug Diary |
| 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 Receives: Other: OhMD APP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start27 Dec 2019
- Primary completion27 Dec 2026 (estimated)
- Study completion27 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margaret Barton-Burke, PhD, RN, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216576
- Sponsor's protocol ID
- 19-458
- Status last verified
- Mar 2026
- First submitted
- 30 Dec 2019
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39697813
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Self-Management of Palbociclib (Ibrance®) Using Mobile Technology
- ClinicalTrials.gov ID
- NCT04216576
- Acronym / sponsor ID
- 19-458
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Palbociclib, Memorial Sloan Kettering Cancer Center, 19-458
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 27 Dec 2019 (actual)
- Primary completion
- 27 Dec 2026 (estimated)
- Study completion
- 27 Dec 2026 (estimated)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Paper Drug DiaryParticipants will have a diagnosis of breast cancer and will be taking Palbociclib. Participants will receive standard of care |
| Standard of Care + Intervention | Experimental | Other: OhMD APPParticipants will have a diagnosis of breast cancer and will be taking Palbociclib. Participants will receive standard of care + unidirectional text messaging intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- History of taking palbociclib (Ibrance)
- Patients whose caregivers coordinate their health care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paper Drug DiaryParticipants will receive and use a paper Drug Diary and a paper medication calendar. | Other | Standard of Care |
| OhMD APPAlso: Unidirectional text messagingParticipants will receive multiple text messages regarding administration over time on medication self-management over the course of 3 cycles of medication | Other | Standard of Care + Intervention |
Primary outcome
Accuracy rate of medication self-administration
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Derived from this study: PubMed 39697813Mazzella-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.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Barton-Burke, PhD, RN principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paper Drug Diary and OhMD APP in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy rate of medication self-administration (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04216576, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.