Education & Empowerment for Breast Cancer Screening Compliance

(MADRE Trial)

Recruiting at 1 trial location

Overseen By Jocelyn Perez

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Previous BC diagnosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively different strategies help women adhere to breast cancer screening guidelines. It will compare two approaches: one empowers women through group activities and personal action plans, while the other emphasizes education about health and lifestyle changes (referred to as "Educate"). Women who identify as Latinas and haven't had a mammogram in the past two years might be suitable candidates. The trial seeks to determine which approach more effectively encourages regular screenings. As an unphased trial, it offers participants the chance to contribute to important research that could enhance breast cancer screening strategies for women.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these interventions are safe for breast cancer screening compliance?

Research shows that participants generally handle empowerment and education sessions with ease. Studies on empowerment programs indicate they can reduce stress and boost emotional well-being in cancer patients. No significant negative side effects have been reported. Similarly, educational programs have successfully encouraged more people to participate in cancer screenings without major problems. These findings suggest that both approaches are safe for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Education & Empowerment approach for breast cancer screening because it combines tailored education with empowerment strategies, which is quite different from traditional methods that mostly focus on awareness and reminders. The "Empower" sessions uniquely involve personal action plans and role-playing activities, providing participants with practical tools and strategies to overcome barriers and promote screening within their networks. Meanwhile, the "Educate" sessions focus on comprehensive education about breast cancer and lifestyle changes, supported by Community Health Worker testimonials and empirical data. This dual approach aims not only to inform but also to motivate and equip individuals to take proactive steps towards regular screening, potentially increasing compliance rates beyond what standard educational campaigns achieve.

What evidence suggests that this trial's treatments could be effective for breast cancer screening compliance?

Research has shown that helping patients navigate the healthcare system can greatly increase breast cancer screening rates. In this trial, participants will attend different sessions. The Empower (Empowerment + Navigation) Sessions aim to make patients feel more informed and better prepared to manage their health. Similarly, the Educate (Education + Navigation) Sessions focus on increasing screening rates and raising awareness about breast cancer. These efforts aim to remove obstacles to screening and encourage healthy habits, leading to greater participation in breast cancer screenings. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for Latina women aged 50-74 who have not had a mammogram in the past two years and have no personal history of breast cancer. They should not have volunteered in health studies before, nor be enrolled in certain parts of this study.

Inclusion Criteria

Aim 1: (1) Female biological sex; (2) Identification as Latinas; (3) Non-adherence to USPSTF guidelines (52-74 years old, no mammogram in past 2 years, no previous BC diagnosis); (4) No previous history of health volunteerism; and (5) Not a network member enrolled in Aim 2.

Aim 2: (1) Female biological sex; (2) Eligibility to obtain BC screenings by USPSTF guidelines (i.e., 50-74 years old, no personal BC history); (3) Referral from non-adherent Latinas; (4) No previous history of health volunteerism; and (5) No participation in the RCT (not an Aim 1 participant, no Session #3 attendance)

Exclusion Criteria

Aim 1: Not meeting at least one of the aforementioned Aim 1 inclusion criteria.

Aim 2: Not meeting at least one of the aforementioned Aim 1 inclusion criteria.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive empowerment or education sessions focusing on BC knowledge, disparities, and screening strategies

12 weeks

3 sessions (in-person or virtual)

Follow-up

Participants are monitored for long-term effects of interventions on BC screening adherence

4 years

What Are the Treatments Tested in This Trial?

Interventions

• Educate
• Empower

Trial Overview The study tests how education and empowerment strategies affect Latinas' adherence to recommended breast cancer screenings. It uses social network analysis and implementation science within a randomized clinical trial to compare long-term effects.

How Is the Trial Designed?

Group I: Empower (Empowerment + Navigation) Sessions Experimental Treatment 1 Intervention

Session 1 BC knowledge, BC disparities, USPSTF guidelines, barriers and preferred solutions to BC screening CHW testimonials, Empirical data, Individual action plans for BC screening Sessions 2 \& 3 BC screening as leading by example, BC promotion strategies that reflect personal and network members' preferences, opportunities to volunteer/be a part of tight-knit initiatives, partnerships with navigators/CHWs to serve as "bridges" for network members CHW testimonials , resource guides for BC promotion, individual action plans for promoting BC, role playing activities (session 2) Participant testimonials, participant relays empirical data, group discussion and plans for promoting BC (session 3)

Group II: Educate (Education + Navigation) Sessions Experimental Treatment 1 Intervention

Session 1 BC knowledge, BC disparities, USPSTF guidelines, barriers and preferred solutions to BC screening, Community Health Workers (CHW) testimonials, empirical data, individual action plans for BC screening Session 2 \&3 Health knowledge (diet and physical activity guidelines), barriers and preferred solutions to dietary and physical activity change, CHW testimonials, empirical data, individual action plans for diet

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Published Research Related to This Trial

A training program on breast health significantly increased awareness of breast cancer symptoms and early detection methods among 462 women, with notable improvements in knowledge after education (P < .05).

After breast self-examination (BSE) training, 85% to 92% of participants demonstrated competency in BSE steps, compared to only 4.3% to 18.7% before training, highlighting the effectiveness of practical training in improving skills for early detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of training for breast cancer and breast self-examination in women aged 40 and over. Budakoglu, II., Maral, I., Ozdemir, A., et al.[2019]

A new tool for clinicians in inpatient oncology units has been developed to prevent adverse events and enhance patient safety, focusing specifically on cancer patients.

The tool includes a catalog of adverse events and a risk map, which helps healthcare providers implement best practices in their daily activities to improve clinical safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient safety in the inpatient setting through risk assessment and mitigation. Reche Navarro, MN.[2016]

A new patient education program was developed for newly diagnosed breast cancer patients based on insights from interviews with 30 patients and 22 healthcare providers, ensuring the information is relevant and understandable.

The resulting website, which answers key questions about diagnosis and treatment, received positive feedback from 12 beta-test patients, who found it clear, informative, and easy to use, highlighting its potential to alleviate patient anxiety and improve understanding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of patient and provider perspectives to develop a patient-oriented website for women diagnosed with breast cancer. Clayman, ML., Boberg, EW., Makoul, G.[2008]

A two-tier educational program was developed to teach women about breast cancer and the correct way to perform breast self-examinations (BSE), starting with training nurses who then educate the community.

Follow-up interviews indicated that the program successfully motivated women to practice BSE and improved their awareness of proper techniques, which is crucial for early detection of breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a community program to promote early breast cancer detection. Boyle, M., Michalek, A., Bersani, G., et al.[2019]

The trial will assess the effectiveness of a decision aid (DA) compared to a standard brochure in helping women aged 50-69 make informed choices about participating in breast cancer screening, involving a sample of 816 women selected from an initial pool of 8160.

The primary outcome will focus on measuring informed choice based on knowledge, attitudes, and intentions regarding breast cancer screening, with secondary outcomes including participation rates and satisfaction with the information provided.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalised informed choice on evidence and controversy on mammography screening: study protocol for a randomized controlled trial. Roberto, A., Colombo, C., Candiani, G., et al.[2018]

Only 16% of women at increased risk of breast cancer recognized both the potential benefits and major harms of tamoxifen, indicating a significant gap in knowledge about this preventive therapy.

Despite a high subjective feeling of being informed (87.1%), many women (66%) using tamoxifen were unaware of its risks and benefits, suggesting a need for better educational support to enhance informed decision-making regarding tamoxifen use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge of Potential Harms and Benefits of Tamoxifen among Women Considering Breast Cancer Preventive Therapy. Thorneloe, RJ., Hall, LH., Walter, FM., et al.[2021]

In a study of 152 women aged 40 and older in Dhaka, Bangladesh, those with more than 12 years of education were significantly more likely to be aware of breast self-examination (BSE) and mammograms, indicating that education plays a crucial role in breast cancer screening knowledge.

The study found that perceived barriers to mammograms did not influence breast cancer screening practices, suggesting that improving education may be more effective than addressing barriers in promoting screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of educational level on knowledge and use of breast cancer screening practices in Bangladeshi women. Rasu, RS., Rianon, NJ., Shahidullah, SM., et al.[2022]

A new screening tool was developed to identify adverse events (AEs) in cancer care, consisting of 76 specific triggers that can help detect potential safety issues during treatment.

This tool, which categorizes triggers related to general care, vital signs, medications, and laboratory tests, has the potential to improve patient safety and quality of care in oncology, although further testing is needed to validate its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ReCAP: Detection of Potentially Avoidable Harm in Oncology From Patient Medical Records. Lipitz-Snyderman, A., Weingart, SN., Anderson, C., et al.[2021]

A study involving 62 women over 60 years old showed that video self-instruction kits significantly improved proficiency in breast self-examination (BSE) and knowledge about breast cancer after 30 days.

Participants demonstrated marked improvements in both skill demonstrations and lump detection, indicating that tailored educational programs can effectively empower older women in breast cancer awareness and self-screening practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast self-examination proficiency in older women: measuring the efficacy of video self-instruction kits. Wood, RY.[2019]

In a study involving 2757 postmenopausal women with hormone receptor-positive early-stage breast cancer, educational materials did not improve treatment compliance with aromatase inhibitors over a 2-year period, with compliance rates remaining similar between groups (82% for both).

The main reason for treatment discontinuation (9% of patients) was side effects related to aromatase inhibitors, highlighting that patient experiences and side effects significantly influence compliance and persistence in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does patient education work in breast cancer? Final results from the global CARIATIDE study. Markopoulos, C., Neven, P., Tanner, M., et al.[2018]

A quality improvement program that included audits, feedback, and educational activities led to significant increases in adherence to treatment guidelines for premenopausal node-positive breast cancer patients, with improvements in key indicators such as the percentage of patients with >10 resected lymph nodes (from 65.3% to 81.3%) and reported estrogen receptor status (from 84.8% to 96.8%).

The study, which analyzed data from 323 patients in the first period and 155 in the second, highlights the importance of ongoing assessment and tailored interventions to enhance guideline adherence and address variations in treatment quality across different hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to the guidelines of the CCCE in the treatment of node-positive breast cancer patients. Ottevanger, PB., De Mulder, PH., Grol, RP., et al.[2019]

A community-based survey identified that 38.5% of women aged 50-80 were underusing mammography, and 87% of these women could name their regular physicians, highlighting a clear target for educational interventions.

The study found that 45% of surveyed physicians were nonadherers to breast cancer screening guidelines, and 42% had educational needs, indicating a significant opportunity to improve adherence through targeted continuing medical education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methodology for targeting physicians for interventions to improve breast cancer screening. Lane, DS., Messina, CR.[2019]

A plain-language guideline sent to women with abnormal breast screening results was well-received, with 99% finding it easy to read and 89% feeling it clearly explained the next steps.

Despite its usefulness, the guideline did not improve overall satisfaction with the Manitoba Breast Screening Program and increased anxiety in about 25% of the women, indicating a need for additional support for those affected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating information for women referred for breast screening abnormalities. Decker, KM., Harrison, M.[2015]

In a study of 101 adult cancer patients undergoing chemotherapy, 83% reported experiencing adverse events, highlighting the common side effects of anticancer drugs.

The research found that 11% of adverse events and a significant portion of medical consultations and hospitalizations were linked to a lack of therapeutic education, emphasizing the need for better patient education on treatment and supportive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Potential clinical impact of therapeutic education in patients treated with anticancer drugs]. Santucci, R., Aatmani, AE., Lescoute, A., et al.[2017]

A pharmacist-led program effectively managed adverse events in 123 patients with EGFR mutation-positive non-small cell lung cancer receiving afatinib, highlighting the importance of patient education and proactive monitoring in a community oncology setting.

Common adverse events included diarrhea (85%) and rash/skin reactions (58%), with 13% of patients discontinuing treatment due to these side effects; however, those who continued treatment often had dose reductions, indicating a strategy to maintain therapy despite adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacist-led patient education and adverse event management in patients with non-small cell lung cancer receiving afatinib in a community-based, real-world clinical setting. Khrystolubova, N., Shieh, M., Patel, AJ., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7795851/

The Effectiveness of Educational Interventions on Breast ... This review paper aimed to systematically evaluate the effectiveness of various educational interventions in improving BCS uptake, knowledge, and beliefs among ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36635866/

Effectiveness of a Breast Cancer Education Screening and ... Aims: The objective of this study was to determine the effectiveness of a multilevel, multicomponent community-based breast cancer screening ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/cam4.6050

Components and effectiveness of patient navigation ... Patient navigation increased participation to screening in breast, cervical and colorectal cancer in comparison with usual care and educational ...

4. ebccp.cancercontrol.cancer.gov ebccp.cancercontrol.cancer.gov/viewProduct.do?viewMode=preview&productId=851134

Project SAFe: The Screening Adherence Follow-Up ( ... The report provides information about the program's framework, history, and future direction, as well as data on breast and cervical cancer screening outcomes ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1551714424003690

The “Mammograms Available Due to Resources and ... This study will inform the development of empowerment approaches to increase participation in breast cancers screening among Latinas and reduce health ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10358261/

Components and effectiveness of patient navigation ... Patient navigation programmes are effective at increasing participation to breast, cervical and colorectal cancer screening.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10773337/

Advancing health equity in improving breast cancer ... This quality improvement (QI) project aimed to improve mammography screening rates from the baseline of 50% to 60% within 12 months for patients aged 50–74 ...

8. mdpi.com mdpi.com/1660-4601/18/1/263

The Effectiveness of Educational Interventions on Breast ... There have been various systematic reviews on the significance of educational interventions as necessary components to encourage breast cancer screening ...

9. academic.oup.com academic.oup.com/abm/article/58/5/314/7627362

Patient Navigation Plus Tailored Digital Video Disc Increases ... The purpose of this study was to compare the effects of two interventions aimed at increasing CRC screening—a mailed tailored digital video disc ...

10. cdc.gov cdc.gov/pcd/issues/2022/22_0155.htm

Implementing Educational and Systems-Level Changes to ... As of 2022, only 51% of active eligible state employees in Missouri have been screened for colorectal cancer and 67% for breast cancer, despite ...