Adherence Intervention for Breast Cancer Treatment Compliance

Overseen By Research Nurse Navigator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Must be taking: Endocrine therapy, Antihypertensives, Statins

Disqualifiers: Breast cancer recurrence, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 52

Duration: 24 weeks

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help individuals with early-stage breast cancer adhere to their prescribed medications. It targets those taking both endocrine therapy for breast cancer and medication for cardiovascular disease. Participants will engage in a special support program, the Multicomponent Adherence Intervention, to enhance their medication adherence. Researchers will evaluate the results using surveys and pharmacy data. This trial suits individuals who completed initial breast cancer treatments within the last three years and have faced challenges in consistently taking their medications. As an unphased trial, it offers a unique opportunity to contribute to research that could improve medication adherence for many patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since the study focuses on adherence to both endocrine therapy and cardiovascular medications, it seems likely that you will continue taking them.

What prior data suggests that this multicomponent adherence intervention is safe?

Research has shown that programs involving active patient participation can effectively help people adhere to their treatment plans. These programs aim to improve medication adherence for conditions like breast cancer and heart disease.

Specific safety data for this particular program is not available, but such programs typically focus on enhancing communication and providing support. They are non-invasive, meaning they do not involve medications or procedures that could cause physical side effects, making them generally easy for patients to manage.

For those considering joining a trial with this program, its primary goal is to help participants follow their medication plans more effectively and safely. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Multicomponent Adherence Intervention for breast cancer treatment compliance because it aims to improve how well patients stick to their prescribed treatments. Unlike the usual care, which relies on standard guidance from treating providers, this intervention combines multiple strategies to enhance adherence. These strategies might include personalized support, reminders, and educational components, making it a comprehensive approach to tackle the common issue of treatment non-compliance. By potentially increasing adherence, this intervention could improve treatment outcomes and overall patient well-being.

What evidence suggests that this multicomponent adherence intervention is effective for improving treatment compliance in early-stage breast cancer patients?

This trial will compare a Multicomponent Adherence Intervention with Usual Care to assess treatment compliance in breast cancer patients. Research has shown that combining several methods, as in the Multicomponent Adherence Intervention, can improve patients' adherence to treatment plans. These methods often involve active patient participation, which has improved medication adherence. A review of studies found that these strategies help women with breast cancer maintain their hormone therapy. Additionally, studies suggest that effective communication in these methods is crucial for supporting patients in following their treatment routines. Overall, using multiple methods together appears promising for encouraging consistent medication adherence. ^{1 2 3 6 7}

Who Is on the Research Team?

Dawn Hershman, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

The IMPACT Trial is for men and women over 18 with early-stage breast cancer who are on endocrine therapy and a CVD medication but have trouble sticking to their treatment. They must be within 3 years of completing initial treatments like surgery or chemo, speak English or Spanish, and see a doctor in the New York Presbyterian Health system.

Inclusion Criteria

I am taking medication for heart disease prevention.

Self-report of at least some nonadherence ET or CVD medication on DOSE-Nonadherence Extent of Nonadherence questionnaire

I finished my initial cancer treatments, except for HER2 therapy, within the last 3 years.

Exclusion Criteria

I am unable to understand or follow the study's requirements due to cognitive issues.

My breast cancer has come back.

Non-English or Non-Spanish speaking

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a multicomponent adherence intervention for endocrine therapy and CVD medication

24 weeks

Regular visits for adherence assessment

Follow-up

Participants are monitored for adherence and health outcomes after the initial treatment phase

28 weeks

Follow-up assessments at 52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Multicomponent Adherence Intervention

Trial Overview This study tests if a special program helps people with breast cancer take their hormone therapy and heart meds better compared to usual care. It checks how well patients follow their prescriptions using questionnaires and pharmacy records at the six-month mark.

How Is the Trial Designed?

Group I: Usual Care Experimental Treatment 1 Intervention

Usual Care from treating providers

Group II: Adherence Intervention Experimental Treatment 1 Intervention

Multicomponent Adherence Intervention

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

The ADHERE intervention, which included a face-to-face session and three follow-up phone calls, significantly reduced symptom severity in patients taking oral anticancer agents, indicating its effectiveness in symptom management.

Patients reported high satisfaction with the ADHERE program, and self-reported adherence to medication was high across both the intervention and control groups, suggesting that the intervention did not negatively impact adherence rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral Anticancer Agents: An Intervention to Promote Medication Adherence and Symptom Management . Spoelstra, SL., Sikorskii, A., Majumder, A., et al.[2022]

The CAPER-capecitabine study will involve 90 cancer patients over five treatment cycles to investigate adherence to the oral medication capecitabine and how patient attitudes and side effects influence this adherence.

By analyzing patient-reported side effects and blood samples for key metabolites, the study aims to uncover factors affecting medication adherence, which could help healthcare professionals create better support strategies for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of capecitabine in daily practice: a study on adherence and patients' experiences. Timmers, L., Swart, EL., Boons, CC., et al.[2022]

A new Italian questionnaire, A-BET, was developed to measure therapy adherence among women with breast cancer undergoing oral endocrine therapy, validated with 82 patients, showing excellent content validity and strong internal consistency.

The tool assesses adherence levels, patient awareness of their medication, and factors influencing non-adherence, providing healthcare professionals with a valuable resource to improve patient care and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to endocrine therapy in women with breast cancer: development and preliminary validation of the A-BET questionnaire. Gambalunga, F., Iacorossi, L., Terrenato, I., et al.[2022]

A text-based intervention using daily reminders and interactive surveys significantly improved medication adherence among post-menopausal breast cancer survivors, with 69.2% of participants completing the study requirements.

The intervention not only enhanced self-reported adherence but also led to measurable decreases in hormone levels, confirming the effectiveness of the treatment, while participants and physicians found the intervention beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Adherence to Adjuvant Hormone Therapy Among Patients With Breast Cancer: A Smart Phone App-Based Pilot Study. Krok-Schoen, JL., Naughton, MJ., Young, GS., et al.[2022]

In a study of 40,009 women with breast cancer, higher polypharmacy and pill burden were linked to better adherence to adjuvant endocrine therapy (AET), with 74% of participants remaining adherent in the first year.

Specific medication classes influenced adherence differently; frequent use of lipid-lowering drugs and antihypertensives improved adherence, while opioid analgesics, antidepressants, and insulin therapy were associated with lower adherence rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polypharmacy and Adherence to Adjuvant Endocrine Therapy for Breast Cancer. Calip, GS., Xing, S., Jun, DH., et al.[2022]

Providing structured treatment information to women with estrogen-receptor-positive breast cancer significantly improved their knowledge and satisfaction regarding endocrine therapy, with the percentage of patients aware of their estrogen receptor status rising from 50% to 93%.

Enhanced information not only increased patient satisfaction but also correlated with better adherence to treatment three months later, particularly among older patients, suggesting that improved education can empower patients and reduce disruptions in therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informing women with breast cancer about endocrine therapy: effects on knowledge and adherence. Heisig, SR., Shedden-Mora, MC., von Blanckenburg, P., et al.[2015]

Compliance with adjuvant endocrine therapy for breast cancer is generally high in clinical trials, but real-world data shows a significant drop in persistence after 12 months, with declines of up to 50% in ongoing therapy.

Strategies to improve adherence include enhancing healthcare access, managing side effects, providing patient education, and fostering strong communication between patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving compliance and persistence to adjuvant tamoxifen and aromatase inhibitor therapy. Hadji, P.[2022]

In a study of 921 low-income women with breast cancer, high adherence to tamoxifen and aromatase inhibitors was observed at 88%, with better patient-provider communication linked to higher adherence rates (94% for high communication scores).

Factors such as having comorbid conditions increased adherence odds, while lack of health insurance and side effects from treatment were significant barriers, highlighting the importance of effective communication and support in improving treatment adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to adjuvant hormone therapy in low-income women with breast cancer: the role of provider-patient communication. Liu, Y., Malin, JL., Diamant, AL., et al.[2022]

Multicomponent interventions that actively involve patients, such as education and counseling, are the most effective strategies for improving adherence to osteoporosis medications, based on a systematic review of 15 studies.

The review highlights a shift towards greater patient involvement and shared decision-making in treatment plans, indicating that personalized approaches in collaboration with healthcare providers can enhance medication adherence and persistence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to improve adherence to anti-osteoporosis medications: an updated systematic review. Cornelissen, D., de Kunder, S., Si, L., et al.[2021]

The whole-process case management model significantly reduced anxiety and depression levels in breast cancer patients compared to conventional nursing, indicating improved emotional well-being during treatment.

Patients receiving whole-process case management showed higher treatment compliance and satisfaction, along with a lower incidence of adverse reactions, suggesting it is a more effective nursing approach for breast cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the Whole-Course Case Management Model on Compliance and Satisfaction of Breast Cancer Patients with Whole-Course Standardized Treatment. Jin, L., Zhao, Y., Wang, P., et al.[2022]

In the TEAM trial's German cohort, prior treatment with tamoxifen was found to have a bone-protective effect, resulting in a lower incidence of fractures during subsequent exemestane therapy.

The use of analgesics did not affect patient compliance or overall disease-free survival, indicating that pain management strategies may not influence treatment outcomes in patients receiving exemestane after tamoxifen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compliance, analgesic use and side-effect protection within a German cohort of the TEAM trial. Bossart, M., Becker, M., Hadji, P., et al.[2016]

The THRIVE app, developed through participatory action research with 28 women with early-stage breast cancer, aims to improve adherence to adjuvant endocrine therapy (AET) by facilitating communication about symptoms and barriers, with features tailored to patient preferences.

Feedback from oncology nurses indicated that the app integrates well into clinical workflows, enhancing patient-provider communication without any reported usability issues, which could lead to better management of AET-related symptoms and potentially improve quality of life for breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

THRIVE intervention development: using participatory action research principles to guide a mHealth app-based intervention to improve oncology care. Anderson, JN., Krukowski, RA., Paladino, AJ., et al.[2022]

In a study of 114 patients with early-stage hormone receptor-positive breast cancer, adherence to long-term adjuvant endocrine therapy (AET) was found to be approximately 64% at 2 years and 56% at 5 years, indicating a significant drop over time.

Patients who received intraoperative radiation therapy (IORT) showed notably lower adherence rates to AET, with only 51% adhering at 2 years and 40% at 5 years, suggesting that the type of radiation therapy may impact long-term treatment compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Adherence to Adjuvant Endocrine Therapy Following Various Radiotherapy Modalities in Early Stage Hormone Receptor Positive Breast Cancer. Ward, KA., Muller, DA., Dutta, SW., et al.[2023]

Citations

1. withpower.com withpower.com/trial/phase-breast-cancer-7-2021-8b209

Adherence Intervention for Breast Cancer Treatment ... Research shows that multicomponent interventions, which involve active patient participation, are effective in improving adherence to treatments. Additionally, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7093203/

A systematic review of interventions to improve adherence ... The purposes of this systematic review were to explore studies that examined the impact of interventions or strategies to improve ET adherence among women with ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0960977625005272

Improving medication adherence to endocrine therapy in ... This review aims to explore key aspects of effective communication to enhance medication adherence to AET in breast cancer patients, offering strategies for ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9096640/

Investigation of Intervention Solutions to Enhance Adherence ... Multicomponent interventions are potentially effective in promoting patient adherence to oral anticancer medicines. The seamless integration of ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0960977622000121

Factors influencing five-year adherence to adjuvant ... Adherence to adjuvant endocrine therapy decreased from the first to fifth year of treatment. On average, one-third of patients were not adherent to treatment by ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/pon.6203

“Interventions to increase adherence to oral therapies in ... Here we provide an up-to-date systematic review of the interventions aimed at increasing adherence to oral medication in BC patients.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8818734/

Factors influencing five-year adherence to adjuvant ... On average, adherence fell by 25.5% from the first to the fifth year of treatment. •. Self-reported adherence may overestimate patient adherence. •. Nineteen ...