Adherence Program for Metastatic Breast Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Columbia University
Must be taking: Endocrine therapy, CDK4/6 inhibitors, Antihypertensives, Statins
Disqualifiers: Non-English, Cognitive impairment, others
No Placebo Group
Trial Summary
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.
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?
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
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
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Trial 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 (Behavioral Intervention)
Trial OverviewThe 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
Research Locations NearbySelect from list below to view details:
Columbia University Medical CenterNew York, NY
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Who Is Running the Clinical Trial?
Columbia UniversityLead Sponsor
National Institute on Minority Health and Health Disparities (NIMHD)Collaborator
References
Oral Anticancer Agents: An Intervention to Promote Medication Adherence and Symptom Management . [2022]Symptom burden and poor adherence to oral anticancer agents remain significant clinical problems. This study examined feasibility, preliminary efficacy, and satisfaction with ADHERE, a nurse practitioner intervention that promotes symptom management and adherence among patients prescribed oral agents. The intervention group (which received one semistructured, face-to-face session followed by three weekly telephone sessions using motivational interviewing, brief cognitive-behavioral therapy, and a toolkit to promote self-management) had significantly lower symptom severity postintervention. Self-reported adherence was high and did not differ by group. Patients reported being highly satisfied with the ADHERE intervention. .
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]Efficacy and quality of life (QoL) are key criteria for therapy selection in metastatic breast cancer (MBC). In hormone receptor positive (HR +) human epidermal growth factor receptor 2 negative (HER2 -) MBC, addition of targeted oral agents such as everolimus or a cycline-dependent kinase 4/6 (CDK 4/6) inhibitor (e.g., palbociclib, ribociclib, abemaciclib) to endocrine therapy substantially prolongs progression-free survival and in the case of a CDK 4/6i also overall survival. However, the prerequisite is adherence to therapy over the entire course of treatment. However, particularly with new oral drugs, adherence presents a challenge to disease management. In this context, factors influencing adherence include maintaining patients' satisfaction and early detection/management of side effects. New strategies for continuous support of oncological patients are needed. An eHealth-based platform can help to support therapy management and physician-patient interaction.
Patient-reported Adherence to Adjuvant Aromatase Inhibitor Therapy Using the Morisky Medication Adherence Scale: An Evaluation of Predictors. [2019]Endocrine therapy is part of standard adjuvant therapy for patients with hormone receptor-positive breast cancer and has been shown to improve recurrence-free and overall survival. However, adherence to endocrine therapy is suboptimal and is difficult to measure. In this study we evaluate the feasibility of using the Morisky Medication Adherence Scale (MMAS) to assess patient adherence to aromatase inhibitor (AI) therapy.
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]Women living with metastatic breast cancer (MBC) are at risk of significantly impaired quality of life (QOL), symptom burden, distress and fear of progression, and unmet needs, yet they face barriers to accessing evidence-based psychosocial treatments. Our group therefore developed Finding My Way-Advanced (FMW-A), a web-based self-guided psychosocial program for women with MBC. This study aims to assess its efficacy in improving mental and other QOL domains, distress, fear of progression, unmet needs, and health service utilisation.
Adherence assessment of patients with metastatic solid tumors who are treated in an oncology group practice. [2020]Due to the increase of oral agents nonadherence is an emerging challenge in cancer care. We evaluated how well different assessments match and how adherence could be measured in routine care. For this purpose patients suffering from metastatic solid tumors who were treated with oral anticancer drugs in an oncology group practice were surveyed. Attending oncologists answered a questionnaire, too, and a retrospective analysis of prescription data was conducted. Caregivers who were eligible for an interview were surveyed additionally. 128 patients (70 % female) with a median age of 69 years (36-88) took part, 95 % of all approached patients. 56 % suffered from metastatic breast cancer, 44 % from other metastatic solid tumors. 65 caregivers (60 % female) with a median age of 62 years (21-82) were interviewed as well. Patients were assessed in 84 % as very reliable in medication-taking by their oncologists. This high adherence rate was supported by patients, caregivers and prescription data. However, concordance between assessments of patients, caregivers and oncologists was not substantial. Our method of considering different perspectives to assess adherence has to be improved and validated but could help to evaluate adherence with oral cancer therapy in routine care.
Improving adherence to endocrine hormonal therapy among breast cancer patients: Study protocol for a randomized controlled trial. [2020]Adjuvant endocrine hormonal therapy (EHT) is highly effective and appropriate for nearly all breast cancer patients with hormone receptor-positive tumors, which represent 75% of all breast cancer diagnoses. Long-term use of EHT reduces recurrence rates and nearly halves the risk of death during the second decade after diagnosis. Despite the proven benefits, about 33% of women receiving EHT do not take their medication as prescribed. This causes an increase in the risk for recurrence and death. To promote adherence to EHT among breast cancer patients, this study will develop and pilot-test an intervention consisting of 1) a bilingual, culturally tailored, personalized, interactive smartphone application (app); and 2) support from a patient navigator. The control group will receive usual care. This 2-group randomized control trial will recruit 120 breast cancer patients receiving EHT at the Mays Cancer Center at UT Health San Antonio. The two-year study will have 3-time assessments (baseline, 3 and 6 months). This theory-based intervention will empower patients' self-monitoring and management. It will facilitate patient education, identification/reporting of side effects, delivery of self-care advice, and simplify communication between the patient and the oncology team. The ultimate goal of this innovative multi-communication intervention is to improve overall survival and life expectancy, enhance quality of life, reduce recurrence, and decrease healthcare cost. The anticipated outcome is a scalable, evidence-based, and easily disseminated intervention with potentially broad use to patients using EHT and other oral anticancer agents.
Adherence to endocrine therapy in women with breast cancer: development and preliminary validation of the A-BET questionnaire. [2022]To develop an Italian tool that measures the therapy adherence of women with breast cancer undergoing treatment with oral endocrine therapy.
Development of a Smartphone Program to Support Adherence to Oral Chemotherapy in People with Cancer. [2022]To describe the theoretical, evidence-based and consumer-informed development of a smartphone self-management program aiming to support adherence to oral chemotherapy in adolescents and adults diagnosed with cancer.
Adherence to Adjuvant Aromatase Inhibitor Therapy Among Postmenopausal Hispanic/Latino Women With Breast Cancer. [2021]The purpose of this study was to determine the level of adherence to adjuvant aromatase inhibitor (AI) therapy and factors associated with non-adherence among Hispanic/Latino women with hormonal receptor-positive breast cancer (BC) treated at an academic center at the American-Mexican border city of El Paso, TX.
Improving Adherence to Adjuvant Endocrine Therapy in Breast Cancer Through a Therapeutic Educational Approach: A Feasibility Study . [2017]To develop and test the feasibility of a tailored therapeutic educational program, with the aim of improving adherence to oral endocrine adjuvant chemotherapy in women with breast cancer. .
Insight into barriers against optimal adherence to oral hormonal therapy in women with breast cancer. [2022]Suboptimal adherence to prescribed oral anticancer agents has been demonstrated in several studies. Understanding the barriers to treatment compliance is becoming increasingly important because of the growing number of oral agents available to treat women with breast cancer.
A systematic review of psychotherapeutic interventions for women with metastatic breast cancer: Context matters. [2019]To summarise the evidence-base of psychological interventions for women with metastatic breast cancer, by mode of delivery (group, individual, or low-intensity interventions). To synthesise data regarding core intervention-elements (eg, intervention duration) and context factors (trial setting, uptake and adherence, and demographic characteristics).