Adherence Intervention for Breast Cancer Treatment Compliance
Recruiting in Palo Alto (17 mi)
Overseen byDawn Hershman, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Columbia University
Must be taking: Endocrine therapy, Antihypertensives, Statins
Disqualifiers: Breast cancer recurrence, Cognitive impairment, others
No Placebo Group
Trial Summary
What is the purpose of this trial?To determine the efficacy of a multicomponent adherence intervention among participants with early-stage breast cancer on endocrine therapy and at least one oral cardiovascular disease (CVD) medication on adherence to endocrine therapy and to CVD medication at 24 weeks assessed by self-report using the Domains of Subjective Extent (DOSE)-Nonadherence questionnaire and also by pharmacy fill data assessed in the electronic health record (EHR).
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 data supports the effectiveness of the Multicomponent Adherence Intervention treatment for breast cancer treatment compliance?
Research shows that multicomponent interventions, which involve active patient participation, are effective in improving adherence to treatments. Additionally, good communication between patients and healthcare providers significantly boosts adherence to hormone therapies in breast cancer patients.
12345Is the Adherence Intervention for Breast Cancer Treatment Compliance safe for humans?
The research articles provided do not contain specific safety data for the Adherence Intervention for Breast Cancer Treatment Compliance or its variants. They focus on adherence to treatment and related factors, but do not address the safety of the intervention itself.
678910How is the Multicomponent Adherence Intervention treatment different from other treatments for breast cancer?
The Multicomponent Adherence Intervention is unique because it focuses on improving patients' adherence to their prescribed breast cancer treatments, which is often a challenge. It likely includes strategies like patient education, better communication with healthcare providers, and possibly technology-based tools to support patients in sticking to their treatment plans.
58111213Eligibility Criteria
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.
+2 more
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
+2 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Usual CareExperimental Treatment1 Intervention
Usual Care from treating providers
Group II: 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. .
Adherence to adjuvant hormone therapy in low-income women with breast cancer: the role of provider-patient communication. [2022]To assess the impact of patient-provider communication on adherence to tamoxifen (TAM) and aromatase inhibitors (AIs) 36 months after breast cancer (BC) diagnosis in a low-income population of women. California statewide surveys were conducted among 921 low-income women with BC at 6, 18, and 36 months after BC diagnosis. A subset of 303 women with stage I-III BC who initiated hormone treatment after diagnosis was identified. Bivariate and multivariate logistic regression analyses were performed, and adjusted adherence rates were calculated. The main outcome measure was self-reported hormone use at 36 months after BC diagnosis and the chief independent variables were patient-centered communication after diagnosis by patient report as measured by the Consumer Assessment of Healthcare Providers and Systems (CAHPS) and patients' self-efficacy in patient-physician interactions (PEPPI). Overall adherence to TAM/AI was relatively high (88 %). Adjusted rates of adherence were 59 and 94 % for patients with the lowest versus highest scores on the CAHPS communication scale (AOR = 1.22, P = 0.006) and 72 versus 91 % for patients with the lowest and highest rating of PEPPI (AOR = 1.04, P = 0.04). Having at least one comorbid condition also increased the odds of adherence to hormonal therapy (AOR = 3.14, P = 0.03). Having no health insurance and experiencing side-effects from hormone treatment were barriers for adherence (AOR = 0.12, P = 0.001; AOR = 0.26, P = 0.003, respectively). Patient-centered communication and perceived self-efficacy in patient-physician interaction were significantly associated with patient adherence to ongoing TAM/AI therapy among low-income women with BC. Interventions on patient-provider communication may provide opportunities to improve patient outcomes in this vulnerable population.
Interventions to improve adherence to anti-osteoporosis medications: an updated systematic review. [2021]An earlier systematic review on interventions to improve adherence and persistence was updated. Fifteen studies investigating the effectiveness of patient education, drug regimen, monitoring and supervision, and interdisciplinary collaboration as a single or multi-component intervention were appraised. Multicomponent interventions with active patient involvement were more effective.
Efficacy of the Whole-Course Case Management Model on Compliance and Satisfaction of Breast Cancer Patients with Whole-Course Standardized Treatment. [2022]To explore the influence of the whole-course case management model on the compliance and satisfaction of breast cancer patients with the whole-course standardized treatment.
Informing women with breast cancer about endocrine therapy: effects on knowledge and adherence. [2015]Adherence to adjuvant endocrine therapy in women with breast cancer is low, and patients are not informed sufficiently. This study analyzes the effects of a structured treatment information on patients' satisfaction, knowledge, and adherence.
The use of capecitabine in daily practice: a study on adherence and patients' experiences. [2022]Adherence to pharmacological therapy is a complex and multifactorial issue that can substantially alter the outcome of treatment. Especially when using long-term medication, cancer patients have adherence rates similar to those of patients with other diseases. The consequences of poor adherence are poor health outcomes and increased health care costs. Only few studies have focused on the use of oral anticancer agents in daily practice. Information about the reasons for nonadherence is essential for the development of interventions that may improve adherence. This report presents the CAPER-capecitabine protocol, which is designed to study the adherence to capecitabine and the influence of patient attitudes towards medication and self-reported side effects. Furthermore, the relationships between patient characteristics, disease characteristics, side effects, quality of life, patient beliefs and attitudes towards disease and medication, dose adjustments, reasons for discontinuation, and plasma concentration of three of the main metabolites, including the active compound 5-fluorouracil, will be explored.
Compliance, analgesic use and side-effect protection within a German cohort of the TEAM trial. [2016]Compliance is an essential aspect for the success of any medical intervention. Adverse events (AEs) contribute significantly to non-compliance with endocrine treatment. The Tamoxifen Exemestane Adjuvant Multinational (TEAM) trial compared five years of adjuvant exemestane therapy with the sequence of tamoxifen followed by exemestane.
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.
Polypharmacy and Adherence to Adjuvant Endocrine Therapy for Breast Cancer. [2022]Many patients with breast cancer are treated for other conditions and experience polypharmacy with multiple concurrent medications. Our aim was to evaluate polypharmacy in relation to adherence to adjuvant endocrine therapy (AET) in breast cancer.
THRIVE intervention development: using participatory action research principles to guide a mHealth app-based intervention to improve oncology care. [2022]Women with hormone receptor-positive, early-stage breast cancer who adhere to adjuvant endocrine therapy (AET) reduce the risk of cancer recurrence and mortality. AET, however, is associated with adverse symptoms that often result in poor adherence. We applied participatory action research (PAR) principles to conduct focus groups and interviews to refine and enhance a web-enabled app intervention that facilitates patient-provider communication about AET-related symptoms and other barriers to adherence.
Long-Term Adherence to Adjuvant Endocrine Therapy Following Various Radiotherapy Modalities in Early Stage Hormone Receptor Positive Breast Cancer. [2023]We compared the rates of long-term adjuvant endocrine therapy (AET) adherence after various radiation therapy (RT) modalities among patients with early stage breast cancer.
Improving compliance and persistence to adjuvant tamoxifen and aromatase inhibitor therapy. [2022]Better compliance and persistence with therapy are associated with improved patient outcomes. As more and more patients survive breast cancer, compliance with adjuvant therapy becomes increasingly important. In clinical trials, compliance with adjuvant endocrine therapy among women with breast cancer is usually high. Retrospective analyses of databases and medical records from clinical practice, insurance databases of prescription refills, and survey data show a significant decrease in persistence after 12 months of therapy. With ongoing therapy, a further decline in persistence of up to 50% has been reported. A consistent methodology is needed to measure patient behavior and identify patients who are not adhering to therapy. Promising strategies for enhancing adherence to treatment in clinical practice include improving access to health care, increasing patient satisfaction, managing side effects, patient education, and better communication between the patient and health care provider. Positive relationships between patients and their health care providers, and frequent monitoring and feedback, may be most effective. While the lack of conformity across studies in measuring makes cross-study comparisons difficult, this review evaluates the available data regarding compliance and persistence with adjuvant endocrine therapies for breast cancer (tamoxifen and aromatase inhibitors) and presents strategies for improving adherence.
Increasing Adherence to Adjuvant Hormone Therapy Among Patients With Breast Cancer: A Smart Phone App-Based Pilot Study. [2022]This study tested the feasibility and efficacy of using a text-based intervention to increase initiation, decrease discontinuation, and improve adherence as prescribed to adjuvant hormone therapy (AHT) among hyphenate post-menopausal breast cancer survivors.