Screening Interventions for Breast Cancer

FA
Overseen ByFoluso Ademuyiwa, MD, MPH, MSCI
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Washington University School of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to boost breast cancer screening among Black women by offering a personalized program that addresses common barriers. Researchers seek to determine if this approach helps more women adhere to their mammogram schedules, potentially reducing health disparities in breast cancer outcomes. Participants will either receive usual care or join the new culturally tailored patient-centric program, which includes mail reminders, phone counseling, and a video explaining the mammogram process. Black women who are at least 40 years old and scheduled for a screening mammogram within eight weeks may be a good fit.

As an unphased trial, this study provides participants the opportunity to contribute to innovative strategies that could improve health outcomes for Black women.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on increasing mammography screening, so it's unlikely that medication changes are required.

What prior data suggests that this culturally tailored patient-centric program is safe?

Research has shown that programs tailored to cultural needs are generally safe and well-received by participants. For instance, a study on a program for Korean women demonstrated positive outcomes without any safety issues. These programs typically include educational materials, personalized advice, and communication that respects participants' cultural backgrounds.

Another study involving Micronesian women found increased participation in breast cancer screening, with no negative effects reported. These programs aim to be supportive and informative rather than intrusive, likely contributing to their safety.

No specific negative events have been reported in similar cultural programs, making them a safe option for those seeking to increase breast cancer screening. However, differences in program design can complicate direct comparisons. Overall, existing research supports the safety of culturally tailored programs.12345

Why are researchers excited about this trial?

Researchers are excited about the Culturally Tailored Patient-Centric Program because it offers a personalized approach to overcoming barriers to breast cancer screening. Unlike the usual care, which simply involves a generic reminder call, this program includes tailored mail reminders, personalized phone counseling, and an informative digital video. These elements aim to address specific cultural and logistical obstacles that might prevent individuals from completing their mammograms. By engaging patients in a more meaningful and culturally sensitive way, the program has the potential to improve screening rates and early detection of breast cancer.

What evidence suggests that the Culturally Tailored Patient-Centric Program is effective for increasing screening mammography among Black women?

Research has shown that programs tailored to cultural needs can increase breast cancer screening rates. In this trial, participants in Arm 2 will receive a Culturally Tailored Patient-Centric Program, which includes mail reminders, tailored telephone counseling, and a digital navigation video. One study found that such tailored programs led to an 18% increase in women getting mammograms. Another study discovered that 92.85% of women who received personalized phone calls agreed to schedule a screening. These programs, designed for diverse groups, have helped reduce disparities in screening rates among underserved communities. They focus on providing personalized support and education, making it easier for people to access and complete their screenings.678910

Who Is on the Research Team?

FA

Foluso Ademuyiwa, MD, MPH, MSCI

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for Black women, age 40 or older, who speak English and are scheduled for a screening mammogram within the next 8 weeks. Participants must be able to give consent and cannot have had breast cancer before or have serious health or sensory issues that would prevent participation.

Inclusion Criteria

English-speaking
I am scheduled for a screening mammogram within 8 weeks of joining the study.
I am a woman.
See 3 more

Exclusion Criteria

I have had breast cancer before.
Scheduled for a diagnostic mammogram
I do not have any serious illness that would prevent me from joining the study.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either usual care or a culturally tailored patient-centric program to increase adherence to screening mammography

6 months
All procedures are carried out remotely with no additional research visits

Follow-up

Participants are monitored for adherence to screening mammography and no-show rates

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Culturally Tailored Patient-Centric Program

Trial Overview

The study tests different ways to encourage women to get regular mammograms: mailed reminders, phone counseling, digital videos, and automated calls. Participants are randomly assigned to these interventions to see which works best at improving screening rates.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arm 2: Culturally Tailored Patient Centric Program MethodsExperimental Treatment3 Interventions
Group II: Arm 1: Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

National Comprehensive Cancer Network

Collaborator

Trials
121
Recruited
7,400+

Novartis

Industry Sponsor

Trials
1,646
Recruited
2,778,000+
Vasant Narasimhan profile image

Vasant Narasimhan

Novartis

Chief Executive Officer since 2018

MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government

Shreeram Aradhye profile image

Shreeram Aradhye

Novartis

Chief Medical Officer since 2022

MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania

Citations

Long-Term Impact of a Culturally Tailored Patient Navigation ...

The culturally and language-tailored PN program designed to reduce disparities in breast cancer screening among refugees appeared to have some lasting effect.

Increasing Breast Cancer Screening Rates Among Women ...

Results: Sixty one percent of the patients called (n=14) were successfully contacted. Of this number, 92.85% accepted screening and scheduled an ...

Effect of culturally tailored education on attendance at ... - PMC

The effect of culturally tailored educational interventions on attendance at mammography was an increase of 18 percent (RR = 1.18, 95% CI, 1.09‐ ...

Brem Foundation Improves Breast Cancer Outcomes for ...

The foundation's newly launched online risk assessment tool, CheckMate, enables women to utilize their personal and family medical history ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/30122671/

Outcomes of a Community-based Breast Cancer Screening ...

Program outcomes and correlates of program retention and BC detection are summarized. Results: Data for 5,669 enrollees and 10,357 mammograms were analyzed.

What Is the Evidence Globally for Culturally Safe Strategies to ...

The aim was to systematically assess the evidence on whether cultural safety affects breast cancer outcomes with regards to care for Indigenous women in ...

A Culturally Tailored Educational Program for Breast ...

This study evaluated the effectiveness of a culturally tailored educational program, the Korean Breast Cancer Risk Reduction Program (KBCRRP), ...

Design and Results of a Culturally Tailored Cancer ...

The purpose of this article is to describe an 18-month project designed in partnership with Micronesian women to increase breast cancer screening in this ...

Strategies for Tailoring Patient-Centered Technologies ...

Methods: A scoping review will explore how HITs have been culturally tailored to underserved populations using PubMed, Scopus, and Web of ...

Reducing Disparities in Breast Cancer Screening

Variability in data collection, patient follow-up practices, and outcome reporting make it difficult to compare across programs or regions (Wheeler et al., 2022) ...