What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as radiotherapy, endocrine therapy, and chemotherapy, have various side effects. Radiotherapy can cause temporary anxiety, depression, and fatigue. Endocrine therapies like tamoxifen and aromatase inhibitors may lead to hot flashes, bone density loss, fractures, and cardiovascular risks. Chemotherapy often results in side effects like nausea, hair loss, fatigue, and increased risk of infections. These treatments can also impact mental health, leading to anxiety and depression.

What prior FDA approvals exist?

The FDA has approved various treatments for breast cancer, including hormone therapies, chemotherapy, targeted therapies, and immunotherapies. Hormone therapies like tamoxifen and aromatase inhibitors (e.g., anastrozole, letrozole) are used for hormone receptor-positive breast cancer. Chemotherapy agents such as doxorubicin and paclitaxel are commonly used. Targeted therapies include trastuzumab for HER2-positive breast cancer and CDK4/6 inhibitors like palbociclib. Immunotherapies, such as pembrolizumab, have also been approved for certain types of breast cancer. While these treatments are not directly related to behavioral encouragement, they represent the broad spectrum of FDA-approved options for managing breast cancer.

What other types of research exist?

Promising novel alternatives to nudging for breast cancer patients considering treatment in 2024 include personalized medicine approaches, such as genomic testing to tailor treatments to individual genetic profiles, and integrative therapies like mindfulness-based stress reduction (MBSR) to improve mental well-being and treatment adherence. Additionally, the use of digital health tools, such as mobile apps and telemedicine platforms, can provide continuous support and personalized care plans, enhancing patient engagement and decision-making.

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Nudges for MRI Screening in Women with Dense Breasts

N/A

Waitlist Available

Led By Anne Marie McCarthy, PhD

Research Sponsored by Abramson Cancer Center at Penn Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Provider needs to have ordered the initial screening mammogram

Women aged 40-74

Must not have

Prior history of breast cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if sending reminders can increase the use of MRI scans among women with extremely dense breasts. These women are at higher risk for breast cancer, and MRIs can detect tumors that regular mammograms might miss. The study hopes these reminders will lead to better cancer detection.

Who is the study for?

This trial is for women aged 40-74 with extremely dense breasts who had a non-actionable mammogram within the last 6 months at specified Penn Medicine locations. They must have a valid mobile number, and their provider should have ordered the initial mammogram. Women with prior breast cancer or recent MRI/ultrasound are excluded.

What is being tested?

The study tests if 'nudges' to either patients, providers, or both can increase breast MRI screenings among women with very dense breasts. It also examines if there's a difference in response between Black and White women.

What are the potential side effects?

Since this trial involves nudging interventions rather than medical treatments, traditional side effects like those seen with medications are not applicable.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My doctor has ordered my first mammogram.

Select...

I am a woman aged between 40 and 74.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had breast cancer before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ordering and/or scheduling of supplemental breast MRI

Secondary study objectives

Cancer detection rate

Completion of breast MRI

False-positive rate

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Provider nudge onlyExperimental Treatment1 Intervention

Nudge sent to provider through EHR.

Group II: Patient nudge onlyExperimental Treatment1 Intervention

Nudge sent to the patient through text messaging.

Group III: Patient and provider nudgeExperimental Treatment2 Interventions

Nudge sent to both provider through EHR, and to patient through text messaging.

Group IV: Usual care (no nudge)Active Control1 Intervention

Usual standard of care, no nudging.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for breast cancer include hormone therapy, HER2-targeted therapy, and chemotherapy. Hormone therapy works by blocking hormones like estrogen that can promote the growth of hormone receptor-positive breast cancer cells. HER2-targeted therapy, such as trastuzumab, targets the HER2 protein on cancer cells, inhibiting their growth and survival. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells. These treatments are crucial as they target specific mechanisms that drive cancer growth, improving survival rates and quality of life for patients. Behavioral encouragement, like nudging, can enhance treatment adherence and utilization, further optimizing patient outcomes.

Progress in psychosocial and behavioral cancer research. The need for enabling strategies.