Adherence Program for Metastatic Breast Cancer

Overseen By Claire Sathe, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Must be taking: Endocrine therapy, CDK4/6 inhibitors, Antihypertensives, Statins

Disqualifiers: Non-English, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 28 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of the Multicomponent Adherence Intervention in helping people adhere to their medication plans for metastatic breast cancer and heart-related issues. The program focuses on enhancing the accessibility and acceptability of digital tools and medications for patients. Individuals with stage IV breast cancer who take specific cancer and heart medications and occasionally miss doses may find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance medication adherence for many patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. It seems to focus on helping you stick to your existing treatments for breast cancer and heart disease.

What prior data suggests that this adherence intervention is safe?

Research shows that the Multicomponent Adherence Intervention, such as the ADHERE intervention, is safe and well-liked by patients. Previous studies found this type of intervention to be safe, with many patients reporting a positive experience. While minor side effects might occur, they are usually manageable and not dangerous. These interventions help patients take their medications on time, and most people have tolerated them well. Overall, this suggests that the intervention is safe for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Multicomponent Adherence Intervention for metastatic breast cancer because it addresses a critical aspect often overlooked in traditional treatments: adherence to prescribed therapies. Unlike standard treatments that focus solely on the pharmacological effects of drugs such as chemotherapy, targeted therapy, or hormone therapy, this intervention is designed to help patients stick to their treatment plans by combining various supportive components. This can potentially lead to better treatment outcomes by ensuring that patients receive the full benefit of their prescribed medications.

What evidence suggests that this adherence intervention is effective for metastatic breast cancer?

Research shows that taking medication as prescribed can greatly benefit people with advanced breast cancer. One study found that programs designed to help patients follow their medication schedules are safe and well-liked. Another study showed that these programs can improve survival rates by ensuring patients follow cancer treatment guidelines. Additionally, adhering to medication plans has been linked to a better quality of life for breast cancer survivors. This trial will evaluate a Multicomponent Adherence Intervention, which aims to help patients take their medicine correctly, potentially leading to better health outcomes. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for men and women over 18 with stage IV/metastatic breast cancer who are on endocrine therapy and a CDK4/6 inhibitor, plus medication for cardiovascular disease risk. Participants must have shown some nonadherence to their medication regimen but be able to consent and follow the study requirements in English or Spanish.

Inclusion Criteria

I am taking medication for heart disease or to prevent it.

I have not always taken my cancer or heart disease medication as prescribed.

I am over 18 years old.

Exclusion Criteria

Inability to provide informed consent for any other reason (e.g, severe psychiatric illness, active substance use)

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

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 targeting digital and pharmaco-equity for 28 weeks

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Multicomponent Adherence Intervention

Trial Overview The trial tests a multicomponent adherence intervention aimed at improving how patients with metastatic breast cancer manage their medications, especially those also at risk of cardiovascular disease. It will evaluate effectiveness, acceptability, and the influence of social factors on sticking to prescribed treatments.

How Is the Trial Designed?

Group I: Single Arm: 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

A survey of 328 breast cancer patients revealed that only 44.2% received consistent encouragement from healthcare professionals about the importance of adhering to oral medications, highlighting a gap in communication that could affect treatment compliance.

Despite 83.6% of patients claiming they took their medication as directed, only 57.4% felt they adhered excellently, indicating that understanding the benefits of adherence and managing side effects are crucial for improving compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insight into barriers against optimal adherence to oral hormonal therapy in women with breast cancer. Kirk, MC., Hudis, CA.[2022]

Psychological interventions for women with metastatic breast cancer can reduce distress, improve coping, and alleviate pain, with group programs showing the strongest evidence for efficacy based on 15 randomized clinical trials.

However, there was no evidence of improved survival rates, and the overall effectiveness of individual and low-intensity interventions remains unclear, highlighting the need for more accessible and effective treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of psychotherapeutic interventions for women with metastatic breast cancer: Context matters. Beatty, L., Kemp, E., Butow, P., et al.[2019]

The Finding My Way-Advanced (FMW-A) program is a web-based self-guided psychosocial intervention designed for women with metastatic breast cancer (MBC), aiming to improve mental quality of life and reduce distress, with a study involving 370 participants across Australia.

This study is the first adequately powered randomized controlled trial to evaluate a self-directed online intervention for MBC, which could significantly enhance quality of life and address unmet needs for women facing barriers to accessing traditional psychosocial treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finding My Way-Advanced: can a web-based psychosocial intervention improve the mental quality of life for women with metastatic breast cancer vs attention-control? Study protocol of a randomised controlled trial. Beatty, L., Kemp, E., Butow, P., et al.[2023]

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 tailored therapeutic educational program for women undergoing oral endocrine chemotherapy for breast cancer showed promising results, with knowledge about treatment improving significantly from an average score of 38.9 to 69.4 out of 100 after the intervention.

The program, which included three sessions, also aimed to enhance trust in treatment, showing a positive trend, although anxiety levels did not significantly change, indicating areas for further improvement in future iterations of the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Adherence to Adjuvant Endocrine Therapy in Breast Cancer Through a Therapeutic Educational Approach: A Feasibility Study . Bourmaud, A., Rousset, V., Regnier-Denois, V., et al.[2017]

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]

A smartphone self-management program was developed to improve adherence to oral chemotherapy in cancer patients, addressing key issues like forgetfulness, side effects, and lack of knowledge about treatment.

The program includes features like medication reminders and tailored information delivery, primarily through simple text messages, based on feedback from end-users, which may enhance its effectiveness in supporting patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Smartphone Program to Support Adherence to Oral Chemotherapy in People with Cancer. Skrabal Ross, X., Gunn, KM., Patterson, P., et al.[2022]

The PreCycle trial, involving 960 patients with hormone receptor positive, HER2 negative metastatic breast cancer, aims to evaluate the impact of an eHealth support system (CANKADO active) on quality of life compared to a basic information service (CANKADO inform).

The study will assess how this enhanced support system affects adherence to treatment with the CDK 4/6 inhibitor palbociclib and its potential to prolong progression-free survival and overall survival by improving patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PRECYCLE: multicenter, randomized phase IV intergroup trial to evaluate the impact of eHealth-based patient-reported outcome (PRO) assessment on quality of life in patients with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer treated with palbociclib and an aromatase inhibitor or palbociclib and fulvestrant. Degenhardt, T., Fasching, PA., Lüftner, D., et al.[2023]

In a study of 100 women with hormone receptor-positive breast cancer, only 50% reported high adherence to aromatase inhibitor therapy, highlighting a significant issue with adherence to this important treatment.

The Morisky Medication Adherence Scale (MMAS) proved to be an effective tool for quickly assessing adherence levels in a clinical setting, revealing that factors such as race and chemotherapy status influenced adherence rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported Adherence to Adjuvant Aromatase Inhibitor Therapy Using the Morisky Medication Adherence Scale: An Evaluation of Predictors. Kesmodel, SB., Goloubeva, OG., Rosenblatt, PY., et al.[2019]

Adjuvant endocrine hormonal therapy (EHT) is crucial for nearly all breast cancer patients with hormone receptor-positive tumors, significantly reducing recurrence rates and the risk of death, yet about 33% of patients do not adhere to their prescribed medication.

This study aims to improve adherence to EHT through a bilingual, culturally tailored smartphone app and support from a patient navigator, with the goal of enhancing patient education, self-management, and ultimately improving survival and quality of life for breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving adherence to endocrine hormonal therapy among breast cancer patients: Study protocol for a randomized controlled trial. Chalela, P., Munoz, E., Inupakutika, D., et al.[2020]

In a study involving 128 patients with metastatic solid tumors, oncologists rated 84% of patients as very reliable in taking their oral anticancer medications, indicating a high adherence rate.

Despite the high adherence ratings, there was a lack of substantial agreement between the assessments of patients, caregivers, and oncologists, suggesting that current methods for evaluating medication adherence need improvement and validation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence assessment of patients with metastatic solid tumors who are treated in an oncology group practice. Feiten, S., Weide, R., Friesenhahn, V., et al.[2020]

In a study of 119 Hispanic/Latino women with hormone receptor-positive breast cancer, 56% exhibited medium to low adherence to adjuvant aromatase inhibitor therapy, indicating a significant challenge in treatment compliance.

Factors contributing to non-adherence included both unintentional reasons like forgetfulness and intentional reasons such as avoiding side effects and difficulties in obtaining medication refills, highlighting the need for targeted support strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to Adjuvant Aromatase Inhibitor Therapy Among Postmenopausal Hispanic/Latino Women With Breast Cancer. Philipovskiy, A., Campbell, A., Heydarian, R., et al.[2021]

Citations

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Assessing multidimensional fidelity in a pilot optimization trial A process evaluation of four intervention components supporting medication adherence in women with breast cancer

2. withpower.com withpower.com/trial/phase-breast-neoplasms-10-2023-78c14

Adherence Program for Metastatic Breast Cancer The ADHERE intervention, which is similar to the Multicomponent Adherence Intervention, was found to be safe and well-received by patients, with high ...

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Enhancing therapy adherence among metastatic breast ... The clinical advancements achieved in anticancer treatments have increased the 5-year survival rate around. 38%. • Oral anticancer treatments (OATs) have ...

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Adherence to breast cancer guidelines is associated with ... Our review of EU studies suggests that there is moderate certainty that adherence to BC guidelines is associated with an improved survival.

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Physical activity interventions for women with metastatic ... Results 1687 records were screened and 96 assessed for eligibility. 28 reports were included (13 full reports, 4 protocols, 11 trial registries) ...

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Electronic Health Interventions for Patients With Breast ... eHealth interventions may provide an acceptable and effective strategy for improving QOL, distress, self-efficacy, and fatigue among patients with breast ...

8. cancer.columbia.edu cancer.columbia.edu/cancer-types-care/clinical-trials/find-clinical-trial/improving-medications-adherence-equitably-among-patients-metastatic-breast-cancerand-cardiovascular-disease

Improving Medications Adherence Equitably among Patients ... The purpose of this study is to evaluate the effect of a multi-part intervention to reduce barriers to medication use. All subjects who are enrolled in the ...