350 Participants Needed

Adherence Intervention for Breast Cancer Treatment Compliance

RN
Overseen ByResearch Nurse Navigator
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Columbia University
Must be taking: Endocrine therapy, Antihypertensives, Statins
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Is 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.678910

How 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.58111213

Research Team

DH

Dawn Hershman, MD

Principal Investigator

Columbia University

Eligibility 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.
See 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
See 2 more

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

Treatment Details

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.
Participant Groups
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

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

References

Oral Anticancer Agents: An Intervention to Promote Medication Adherence and Symptom Management . [2022]
Adherence to adjuvant hormone therapy in low-income women with breast cancer: the role of provider-patient communication. [2022]
Interventions to improve adherence to anti-osteoporosis medications: an updated systematic review. [2021]
Efficacy of the Whole-Course Case Management Model on Compliance and Satisfaction of Breast Cancer Patients with Whole-Course Standardized Treatment. [2022]
Informing women with breast cancer about endocrine therapy: effects on knowledge and adherence. [2015]
The use of capecitabine in daily practice: a study on adherence and patients' experiences. [2022]
Compliance, analgesic use and side-effect protection within a German cohort of the TEAM trial. [2016]
Adherence to endocrine therapy in women with breast cancer: development and preliminary validation of the A-BET questionnaire. [2022]
Polypharmacy and Adherence to Adjuvant Endocrine Therapy for Breast Cancer. [2022]
THRIVE intervention development: using participatory action research principles to guide a mHealth app-based intervention to improve oncology care. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Long-Term Adherence to Adjuvant Endocrine Therapy Following Various Radiotherapy Modalities in Early Stage Hormone Receptor Positive Breast Cancer. [2023]
Improving compliance and persistence to adjuvant tamoxifen and aromatase inhibitor therapy. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Increasing Adherence to Adjuvant Hormone Therapy Among Patients With Breast Cancer: A Smart Phone App-Based Pilot Study. [2022]
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