35 Participants Needed

Adherence Program for Metastatic Breast Cancer

RN
CS
Overseen ByClaire Sathe, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Columbia University
Must be taking: Endocrine therapy, CDK4/6 inhibitors, Antihypertensives, Statins
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Multicomponent Adherence Intervention for metastatic breast cancer?

Research shows that interventions like ADHERE, which include motivational interviewing and cognitive-behavioral therapy, can help patients manage symptoms and stick to their medication plans. This suggests that similar multicomponent adherence programs could be effective for patients with metastatic breast cancer.12345

Is the Multicomponent Adherence Intervention safe for humans?

The ADHERE intervention, which is similar to the Multicomponent Adherence Intervention, was found to be safe and well-received by patients, with high satisfaction reported and no significant safety concerns noted.16789

How does the adherence program for metastatic breast cancer differ from other treatments?

This adherence program is unique because it focuses on improving medication adherence and symptom management through a structured intervention involving motivational interviewing, cognitive-behavioral therapy, and self-management tools, rather than introducing a new drug. It aims to enhance patient satisfaction and reduce symptom severity, which is different from standard treatments that primarily focus on the medication itself.16101112

What is the purpose of this trial?

To evaluate the preliminary efficacy of a multicomponent adherence intervention focused on enhancing digital equity and pharmaco-equity among nonadherent patients with metastatic breast cancer (MBC) and cardiovascular disease (CVD) risk factors on endocrine therapy (ET), CDK4/6 inhibitor (CDK 4/6i), and CVD medications. To assess the acceptability and appropriateness of this intervention in patients with MBC and CVD risk factors through validated measures of implementation outcomes. To gain a deeper understanding of the impact of social determinants of health (SDOH) on medication nonadherence through semi-structured interviews with a subset of study participants.

Eligibility Criteria

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.
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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
See 1 more

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Single Arm: Adherence InterventionExperimental Treatment1 Intervention
Multicomponent Adherence Intervention

Find a Clinic Near You

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+

Findings from Research

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

References

Oral Anticancer Agents: An Intervention to Promote Medication Adherence and Symptom Management . [2022]
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. [2023]
Patient-reported Adherence to Adjuvant Aromatase Inhibitor Therapy Using the Morisky Medication Adherence Scale: An Evaluation of Predictors. [2019]
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. [2023]
Adherence assessment of patients with metastatic solid tumors who are treated in an oncology group practice. [2020]
Improving adherence to endocrine hormonal therapy among breast cancer patients: Study protocol for a randomized controlled trial. [2020]
Adherence to endocrine therapy in women with breast cancer: development and preliminary validation of the A-BET questionnaire. [2022]
Development of a Smartphone Program to Support Adherence to Oral Chemotherapy in People with Cancer. [2022]
Adherence to Adjuvant Aromatase Inhibitor Therapy Among Postmenopausal Hispanic/Latino Women With Breast Cancer. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Improving Adherence to Adjuvant Endocrine Therapy in Breast Cancer Through a Therapeutic Educational Approach: A Feasibility Study . [2017]
11.United Statespubmed.ncbi.nlm.nih.gov
Insight into barriers against optimal adherence to oral hormonal therapy in women with breast cancer. [2022]
A systematic review of psychotherapeutic interventions for women with metastatic breast cancer: Context matters. [2019]
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