Education Program for Breast Cancer Screening

Overseen By Heather Hurwitz, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Not high risk, others

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

Compensation: Varies

Number of Visits: 2

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to identify interventions that are designed to better serve women who are homeless, with a specific focus on increasing screening rates and decreasing late stage breast cancer diagnosis among this high-risk understudied community of women. As a result, the study team hopes to influence the broader homeless healthcare initiative

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 Education Session treatment for breast cancer screening?

An educational session for healthcare providers showed an increase in knowledge about breast cancer risk and treatment, with test scores improving from an average of 67.1% to 80.3% after the session. This suggests that similar educational sessions could effectively increase knowledge about breast cancer screening. ^{1 2 3 4 5}

Is the Education Program for Breast Cancer Screening safe for participants?

The research articles reviewed do not provide specific safety data for the Education Program for Breast Cancer Screening. However, educational programs in healthcare settings generally focus on improving knowledge and safety practices, which suggests they are safe for participants. ^{6 7 8 9 10}

How does the Education Program for Breast Cancer Screening differ from other treatments for breast cancer?

The Education Program for Breast Cancer Screening is unique because it focuses on increasing knowledge and participation in screening programs rather than providing a medical or pharmaceutical treatment. This approach aims to empower individuals with information about early diagnosis and screening methods, which can lead to earlier detection and better outcomes. ^{11 12 13 14 15}

Research Team

Heather Hurwitz, PhD

Principal Investigator

Cleveland Clinic, Case Comprehensive Cancer Center

Eligibility Criteria

This trial is for women under 40 at high risk of breast cancer who haven't had a mammogram in the last year and are staying in homeless shelters or transitional housing in Cleveland. It's not open to those outside this area.

Inclusion Criteria

I am a woman under 40 with high risk breast cancer symptoms or a family history.

Resident at a homeless shelter or transitioning housing facility in the greater Cleveland area

Have not had mammogram in the last 12 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Educational Outreach

Participants complete a survey to elucidate beliefs and barriers around breast health and mammography, followed by a culturally-appropriate educational session about breast health and mammography.

1 day

1 visit (in-person)

Mammography Screening

Eligible women receive a free on-site mammogram from the mobile mammography clinic.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any immediate feedback or issues post-mammography screening.

4 weeks

Treatment Details

Interventions

• Education Session
• Survey

Trial Overview The study tests if education sessions and surveys can help increase breast cancer screening rates among homeless women, aiming to catch cancer earlier.

Participant Groups

Group I: Outreach educational program Experimental Treatment 2 Interventions

Participants will be given a survey to elucidate beliefs and barriers around breast health and mammography. A brief, culturally-appropriate educational session about breast health and mammography will follow and will be delivered by a female public health educator. After education, eligible women will be offered a free on-site mammogram

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Findings from Research

A study involving 35 breast cancer patients showed that while most felt knowledgeable about their condition, their actual understanding was often less accurate, particularly regarding tumor size, type, and grade.

The majority of patients expressed a strong interest in receiving a personalized medical summary, highlighting a need for better information sharing between healthcare providers and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A feasibility study to evaluate breast cancer patients' knowledge of their diagnosis and treatment. Smith, SM., Balise, RR., Norton, C., et al.[2022]

A survey of 767 healthcare providers revealed that while there is interest in identifying and treating high-risk breast cancer patients, many physicians lack up-to-date knowledge on best practices.

An educational session significantly improved participants' knowledge about high-risk breast cancer care, with pre-test scores averaging 67.1% and post-test scores averaging 80.3%, indicating that targeted education can enhance practice patterns in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing breast cancer risk and providing treatment recommendations: immediate impact of an educational session. Gabram, SG., Dougherty, T., Albain, KS., et al.[2015]

Internet-based education significantly improved patients' knowledge levels more than face-to-face education with a nurse in a study involving 147 ambulatory orthopedic surgery patients.

Both education methods were effective in enhancing knowledge, but there was no difference in the sufficiency of knowledge between the two groups, indicating that online education is a viable alternative in ambulatory care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory orthopaedic surgery patients' knowledge with internet-based education. Heikkinen, K., Leino-Kilpi, H., Salanterä, S.[2017]

A survey of 282 patients in an outpatient clinic revealed that while 62.6% felt adequately informed about their chemotherapy, 42.4% still desired more information, indicating a gap in patient education.

Patients expressed a strong preference for receiving chemotherapy information through written materials and discussions with healthcare professionals, highlighting the need for enhanced educational resources on topics like chemotherapy mechanisms and interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of patient chemotherapy education in a gynecology oncology center. Smith, JA., Kindo, CC., Kurian, S., et al.[2018]

Providing women with detailed information about the breast screening recall process significantly reduces distress and increases satisfaction, as shown by a study involving 2,132 women across multiple centers.

Women who received an information leaflet with their recall letter felt more reassured and better understood the assessment process, highlighting the importance of clear communication in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Written information needs of women who are recalled for further investigation of breast screening: results of a multicentre study. Austoker, J., Ong, G.[2017]

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]

Effective clinical drug safety surveillance is crucial for protecting public health and ensuring the commercial success of pharmaceutical products, as it helps monitor and manage adverse drug events.

The process of drug safety surveillance is governed by FDA regulations and involves systematic management of adverse event reports, emphasizing the importance of clear communication and data handling to improve drug safety outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A primer of drug safety surveillance: an industry perspective. Part I: Information flow, new drug development, and federal regulations. Allan, MC.[2019]

An educational program for nursing technicians significantly improved their understanding of how to recognize and record Adverse Events (AEs) in hemodialysis patients, with test scores increasing from an average of 3.7 to 4.2 out of 5 after the intervention.

The program effectively combined classroom and online learning, demonstrating that such training methods can enhance the knowledge and skills of healthcare professionals in managing patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nursing educational intervention for the identification of Adverse Events in hemodialysis. Pássaro, PG., D'Ávila, R.[2019]

A new approach to Morbidity and Mortality (M&M) Conferences has led to a 29% increase in overall satisfaction and a 50% increase in satisfaction regarding the addressing of process improvement issues over 5 years.

The hands-on, educational focus of the revamped M&M Conferences has resulted in 100% of faculty applying what they learn to their practice, suggesting that this model could enhance discussions about adverse events and improve patient safety across the medical community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Innovative and Integrative Approach to Breaking Down Barriers to Traditional Morbidity and Mortality Conference. Tresselt, E., Darnell Bowens, C., Dhar, A.[2023]

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]

A study involving 375 medical university students revealed that while most (96.27%) had good knowledge of mammography and clinical breast examinations, many (82.13%) were aware of breast self-examination but did not know how to perform it.

The majority of students recognized risk factors for breast cancer, such as contraceptive pills (60%) and protective factors like breastfeeding (71.2%), indicating a solid understanding of breast cancer awareness among young female medical students.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer awareness among pharmacy and physiotherapy students of medical university Nawabshah. Irfan, R., Memon, H., Umrani, IN., et al.[2022]

Only 36% of women surveyed understood the lifetime risk of developing breast cancer, indicating a significant gap in knowledge about breast health among the 1000 women aged 49 to 64 in Oxfordshire.

While many women recognized the benefits of screening for early detection and less invasive treatment, 45% mistakenly believed that screening could prevent breast cancer, highlighting the need for better education on the purpose and limitations of breast screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Women's knowledge about breast cancer risk and their views of the purpose and implications of breast screening--a questionnaire survey. Webster, P., Austoker, J.[2016]

A study of 185 women in a rural Appalachian area revealed significant knowledge gaps about breast cancer and screening practices, particularly regarding breast self-examination timing and behaviors.

Women who received education from healthcare providers showed better understanding and adherence to breast cancer screening guidelines, highlighting the need for ongoing education and reinforcement from healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge, attitudes, and practices surrounding breast cancer screening in educated Appalachian women. Leslie, NS., Deiriggi, P., Gross, S., et al.[2015]

A study involving 405 women at Eskişehir Osmangazi University showed that knowledge about breast cancer (BC) screening methods was low before training, with only 11.4% having had a mammogram in the past year.

After a training program, participants' knowledge about BC significantly increased (p=0.001), indicating that educational interventions can effectively raise awareness and potentially improve participation in screening programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educational Study to Increase Breast Cancer Knowledge Level and Scanning Participation among Women Working at a University. Özerdoğan, N., Şahin, BM., Kösgeroğlu, N., et al.[2020]

A study of 1184 Pakistani women revealed a significant lack of knowledge and practices related to breast cancer screening, with 87.9% never having performed a breast self-examination and 98.9% never having undergone a mammogram.

Only 35.5% of participants recognized advancing age as a risk factor for breast cancer, indicating a poor understanding of risk factors associated with the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge, attitude and practices amongst the Pakistani females towards breast cancer screening programme. Sarwar, MZ., Hassan Shah, SF., Yousaf, MR., et al.[2017]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

A feasibility study to evaluate breast cancer patients' knowledge of their diagnosis and treatment. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Assessing breast cancer risk and providing treatment recommendations: immediate impact of an educational session. [2015]

3. Germany pubmed.ncbi.nlm.nih.gov

Ambulatory orthopaedic surgery patients' knowledge with internet-based education. [2017]

4. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of patient chemotherapy education in a gynecology oncology center. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Written information needs of women who are recalled for further investigation of breast screening: results of a multicentre study. [2017]

6. France pubmed.ncbi.nlm.nih.gov

[Potential clinical impact of therapeutic education in patients treated with anticancer drugs]. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

A primer of drug safety surveillance: an industry perspective. Part I: Information flow, new drug development, and federal regulations. [2019]

8. Brazil pubmed.ncbi.nlm.nih.gov

Nursing educational intervention for the identification of Adverse Events in hemodialysis. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

An Innovative and Integrative Approach to Breaking Down Barriers to Traditional Morbidity and Mortality Conference. [2023]

10. England 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. [2020]

11. Pakistan pubmed.ncbi.nlm.nih.gov

Breast cancer awareness among pharmacy and physiotherapy students of medical university Nawabshah. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Women's knowledge about breast cancer risk and their views of the purpose and implications of breast screening--a questionnaire survey. [2016]

13. United States pubmed.ncbi.nlm.nih.gov

Knowledge, attitudes, and practices surrounding breast cancer screening in educated Appalachian women. [2015]

14. Turkey pubmed.ncbi.nlm.nih.gov

Educational Study to Increase Breast Cancer Knowledge Level and Scanning Participation among Women Working at a University. [2020]

15. Pakistan pubmed.ncbi.nlm.nih.gov

Knowledge, attitude and practices amongst the Pakistani females towards breast cancer screening programme. [2017]