Text Message Reminders for Breast Cancer Medication Adherence

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

45 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the drug Palbociclib (Ibrance) for breast cancer medication adherence?

Research shows that using text message reminders can help improve medication adherence in breast cancer patients, although a specific trial with text messages did not show improved adherence, it suggests potential for future strategies. ^{1 2 3 4 5}

Is Palbociclib (Ibrance) generally safe for humans?

The research articles provided do not contain specific safety data for Palbociclib (Ibrance) or its use in humans. They focus on medication adherence and strategies to improve it, rather than safety information. ^{1 2 5 6 7}

What makes the drug Palbociclib unique for breast cancer treatment?

Palbociclib (Ibrance) is unique because it is a targeted therapy that works by inhibiting specific proteins (CDK4/6) involved in cell division, which helps slow the growth of cancer cells. Unlike traditional chemotherapy, it is taken orally and is often used in combination with hormonal therapies to enhance effectiveness. ^{1 2 3 8 9}

Research Team

Margaret Barton-Burke, PhD, RN

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Adjuvant endocrine therapy non-initiation and non-persistence in young women with early-stage breast cancer. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Improving medication adherence with adjuvant aromatase inhibitor in women with breast cancer: A randomised controlled trial to evaluate the effect of short message service (SMS) reminder. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Text Messaging to Increase Compliance with Adjuvant Endocrine Therapy in Breast Cancer. [2021]

4. Netherlands 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. [2019]

5. United States 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. [2020]

6. England 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. [2018]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Palbociclib Adherence and Persistence in Patients with Hormone Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer. [2023]

8. United States 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a Text Messaging Intervention to Promote Self-Management for Patients Prescribed Oral Anticancer Agents. [2015]