400 Participants Needed

Education & Empowerment for Breast Cancer Screening Compliance

Recruiting at 1 trial location
YM
JP
Overseen ByJocelyn Perez
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Illinois at Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Educate, Breast Cancer Education, Breast Health Education, Guideline-Concordant Screening Education, Empower for breast cancer screening compliance?

Research shows that educational materials can improve treatment compliance in breast cancer patients, and plain-language guidelines help women understand abnormal screening results, suggesting that education and empowerment can enhance screening compliance.12345

Is the education program for breast cancer screening compliance safe for participants?

The research highlights the importance of education in reducing adverse events in cancer patients, suggesting that educational programs can improve safety by providing necessary information and support.678910

How does the Education & Empowerment for Breast Cancer Screening Compliance treatment differ from other treatments for breast cancer?

This treatment is unique because it focuses on educating and empowering women to comply with breast cancer screening through community programs, educational materials, and personalized decision aids, rather than using medical interventions. It emphasizes early detection and informed decision-making, which is different from traditional treatments that focus on medical or surgical interventions.1112131415

What is the purpose of this trial?

The design builds on past studies by integrating social network analysis (SNA) and implementation science (IS) into a longitudinal randomized clinical trial (RCT). The investigator will compare the long-term effects of interventions by examining guideline-concordant initial and repeat Brease Cancer (BC) screening.

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Empower (Empowerment + Navigation) SessionsExperimental Treatment1 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) SessionsExperimental Treatment1 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials
653
Recruited
1,574,000+

Findings from Research

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

References

Does patient education work in breast cancer? Final results from the global CARIATIDE study. [2018]
Adherence to the guidelines of the CCCE in the treatment of node-positive breast cancer patients. [2019]
Methodology for targeting physicians for interventions to improve breast cancer screening. [2019]
The use of patient and provider perspectives to develop a patient-oriented website for women diagnosed with breast cancer. [2008]
Evaluating information for women referred for breast screening abnormalities. [2015]
[Potential clinical impact of therapeutic education in patients treated with anticancer drugs]. [2017]
ReCAP: Detection of Potentially Avoidable Harm in Oncology From Patient Medical Records. [2021]
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. [2020]
Knowledge of Potential Harms and Benefits of Tamoxifen among Women Considering Breast Cancer Preventive Therapy. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Improving patient safety in the inpatient setting through risk assessment and mitigation. [2016]
11.United Statespubmed.ncbi.nlm.nih.gov
Effectiveness of a community program to promote early breast cancer detection. [2019]
Effect of educational level on knowledge and use of breast cancer screening practices in Bangladeshi women. [2022]
The effectiveness of training for breast cancer and breast self-examination in women aged 40 and over. [2019]
14.United Statespubmed.ncbi.nlm.nih.gov
Breast self-examination proficiency in older women: measuring the efficacy of video self-instruction kits. [2019]
Personalised informed choice on evidence and controversy on mammography screening: study protocol for a randomized controlled trial. [2018]
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