Text Message Reminders for Breast Cancer Medication Adherence

Not currently recruiting at 6 trial locations

Overseen By AnnMarie Mazzella, PhD, RN

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Palbociclib

Disqualifiers: Caregiver coordination, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if text message reminders help people remember to take palbociclib (also known as Ibrance), a breast cancer medication, on schedule. Participants will be divided into two groups: one will receive standard care, and the other will also receive text reminders through an app. This study targets individuals who are starting palbociclib treatment for the first time, have a breast cancer diagnosis, and own a smartphone capable of receiving text messages. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance medication adherence for future patients.

Do I have to stop taking my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, it mentions that palbociclib can be taken alone or with other medications like Letrozole or Fulvestrant.

What prior data suggests that this text messaging intervention is safe for breast cancer patients?

Research has shown that palbociclib is generally safe for people with breast cancer. A five-year study demonstrated that the safety of palbociclib, when combined with hormone therapy, remained stable and consistent, with no new safety issues emerging over time.

Some patients reduced their dose due to side effects, but this did not affect the overall results. This suggests that even with dose adjustments, the treatment remained effective. Overall, palbociclib is considered well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how text message reminders can boost adherence to breast cancer treatments like Palbociclib. While patients typically rely on standard care to manage their medication schedules, this approach adds a unique layer of support through technology, potentially improving health outcomes. By integrating unidirectional text messaging, the trial aims to find out if these simple, timely nudges can keep patients on track with their medication, making treatment more effective in the long run.

What evidence suggests that text message reminders are effective for breast cancer medication adherence?

Research has shown that palbociclib effectively treats breast cancer. In this trial, participants will receive either standard care with palbociclib or standard care plus a text messaging intervention. Studies have found that text message reminders help patients remember to take their medication on time. For instance, one study discovered that personalized reminders led to high rates of adherence. Another study noted that patients felt these reminders improved their treatment management. Overall, text reminders appear to help patients take palbociclib regularly, enhancing the treatment's effectiveness. ^{6 7 8 9 10}

Who Is on the Research Team?

Margaret Barton-Burke, PhD, RN

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with breast cancer who are starting palbociclib treatment and own a smartphone. They must be able to use the OhMD app, speak English, and manage their own healthcare without relying on caregivers.

Inclusion Criteria

I am 18 or older and starting treatment with Ibrance for breast cancer.

Able to speak, read and write English

I am starting Ibrance for the first time, alone or with Femara or Faslodex.

Exclusion Criteria

Patients who do not have someone to help manage their healthcare.

I have taken the medication Ibrance.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Palbociclib with or without text message reminders

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Palbociclib

Trial Overview The study tests if text message reminders via the OhMD app can help patients remember to take their medication palbociclib as scheduled, compared to using a paper drug diary.

How Is the Trial Designed?

Group I: Standard of Care + Intervention Experimental Treatment 1 Intervention

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

Group II: Standard of Care Active Control 1 Intervention

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

Palbociclib is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Ibrance for:

• HR-positive, HER2-negative advanced or metastatic breast cancer

Approved in European Union as Ibrance for:

• HR-positive, HER2-negative locally advanced or metastatic breast cancer

Approved in Canada as Ibrance for:

• HR-positive, HER2-negative advanced or metastatic breast cancer

Approved in Japan as Ibrance for:

• HR-positive, HER2-negative advanced or recurrent breast cancer

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

A survey of 17 young adult cancer patients revealed that while most understood their treatment, 24% did not receive guidance on what to do if they missed a dose, indicating a gap in medication education.

Common barriers to adherence included side effects (59%), forgetfulness (47%), and depressive symptoms (35%), highlighting the need for improved support systems and education involving family and caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the need for improved strategies and medication-related education to increase adherence for oral anticancer medications in the young adult oncology population. Divakaruni, A., Saylor, E., Duffy, AP.[2018]

In a study of 693 young women with hormone receptor-positive breast cancer, 9% did not start oral adjuvant endocrine therapy (ET) within 18 months, with Black women showing higher odds of non-initiation.

Among those who started ET, 20% were non-persistent, with factors like younger age and marital status influencing adherence; however, non-persistence was linked to lower recurrence rates, suggesting that decision-making support could enhance adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant endocrine therapy non-initiation and non-persistence in young women with early-stage breast cancer. Rosenberg, SM., Zheng, Y., Gelber, S., et al.[2023]

In a study of 3382 women with hormone receptor-positive breast cancer, those with low personal or clinical social support were more likely to not start or adhere to adjuvant endocrine therapy (AET), highlighting the importance of social support in treatment compliance.

Women with moderate or low personal social support had a significantly higher risk of discontinuing AET or being non-adherent, suggesting that healthcare teams should address these support gaps to improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personal and clinical social support and adherence to adjuvant endocrine therapy among hormone receptor-positive breast cancer patients in an integrated health care system. Kroenke, CH., Hershman, DL., Gomez, SL., et al.[2019]

In a study involving 75 adult cancer patients, daily text messages aimed at improving adherence to oral anticancer medications showed high acceptability, with 90% of participants satisfied with the intervention.

While the text message intervention led to improved adherence and perceived social support, the differences in symptom severity and interference between the experimental and control groups were not statistically significant, indicating the need for further research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proof of Concept of a Mobile Health Short Message Service Text Message Intervention That Promotes Adherence to Oral Anticancer Agent Medications: A Randomized Controlled Trial. Spoelstra, SL., Given, CW., Sikorskii, A., et al.[2023]

A pilot study involving 44 postmenopausal women with hormone receptor-positive breast cancer showed that using a web-based app with weekly reminders significantly improved adherence to aromatase inhibitors (AIs) at 8 weeks (100% vs. 72% adherence).

The App+Reminder group also had a higher usage rate of the app (74% vs. 38%), suggesting that reminders can help patients manage their treatment better, potentially leading to better long-term outcomes in cancer survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a web-based app to improve breast cancer symptom management and adherence for aromatase inhibitors: a randomized controlled feasibility trial. Graetz, I., McKillop, CN., Stepanski, E., et al.[2020]

Citations

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Improving Palbociclib adherence among women with ... Our study showed that a personalized intervention using smartbox to monitor palbociclib adherence and bi-directional reminders complemented with smart referral ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04216576

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

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Oral self-management of palbociclib using mobile technology This trial seeks to understand whether patients with MBC perceived that text message reminders help them take their medications as directed, attend clinic and ...

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Oral Self-Management of Palbociclib (Ibrance®) using ... The purpose of this study is aimed at evaluating whether text messaging reminders is an effective and feasible method in strengthening oral anticancer ...

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Improving palbociclib adherence among women with ... The CONnected CUstomized Treatment Platform interventions is feasible, resulting in a high palbociclib adherence rate without any decline in overtime.

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Long‐Term Pooled Safety Analysis of Palbociclib in ... This 5-year, long-term analysis demonstrated that palbociclib plus ET has a consistent and stable safety profile and is a safe treatment for patients with HR+/ ...

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metastatic breast cancer: A Flatiron Health database analysis In the current study, approximately 15 % of patients treated with palbociclib had a reduced starting dose (100/75 mg/day); per protocols, this did not occur in ...

8. nature.com nature.com/articles/s41523-022-00479-x

Real-world study of overall survival with palbociclib plus ... Progression-free survival (95% CI) is 19.3 (17.5–20.7) versus 13.9 (12.5–15.2) months, respectively (hazard ratio, 0.70 [95% CI, 0.62–0.78]; P < ...

9. ascopubs.org ascopubs.org/doi/10.1200/JCO.23.00137

Overall Survival With Palbociclib Plus Letrozole in ... The median OS was 53.9 months (95% CI, 49.8 to 60.8) with palbociclib plus letrozole versus 51.2 months (95% CI, 43.7 to 58.9) with placebo plus ...

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Palbociclib exposure in relation to efficacy and toxicity ... Palbociclib dose reductions and the effect on clinical outcomes in patients with advanced breast cancer. Breast. 2021; 60:263-271. Full Text.