Educational Intervention for Cancer Survivors' Breast Cancer Screening

Not currently recruiting at 1 trial location

Age: 18 - 65

Sex: Female

Trial Phase: Phase 3

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Breast cancer, Project VISION, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help women who survived childhood cancer understand and improve their breast and heart health. Over the course of a year, participants will learn about potential health risks and ways to stay healthy through surveys and questionnaires. The trial specifically targets women who received chest radiation as part of their childhood cancer treatment and have not had a mammogram or breast imaging in the last two years. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to significant advancements in healthcare.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that educational tools like videos and digital apps are generally safe and easy to use. For example, one study found that a breast cancer educational video increased knowledge in 62% of viewers and reduced distress in 30% of them. Another review found that digital health tools improved health outcomes for breast cancer survivors without causing harm.

These results suggest that the educational methods tested in the EMPOWER study are very safe for participants. Since the trial is in a late stage, it has undergone extensive testing, indicating that earlier studies have shown the methods to be safe. Overall, participants can feel confident about the safety of joining this study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on improving breast cancer screening among cancer survivors through educational interventions. Unlike standard breast cancer screening options, which typically rely on traditional imaging methods like mammograms, this trial emphasizes the importance of education and awareness. By using questionnaires and surveys, the trial aims to empower women with knowledge about their health and encourage proactive screening behaviors. This approach is particularly important for those who have undergone chest radiation and might be at higher risk, offering a personalized method to increase screening rates and potentially improve early detection outcomes.

What evidence suggests that these educational interventions are effective for improving breast cancer screening in cancer survivors?

This trial will compare an educational intervention with an attention control group to assess its impact on breast cancer screening among cancer survivors. Research has shown that educational programs effectively increase knowledge and change attitudes about breast cancer screening. Studies have found that these programs encourage more women to participate in screenings. Specifically, clear information and guidance can greatly influence women's views and participation in these screenings. While some educational efforts might not lead to immediate action, they can prepare women to make better health decisions in the future. Overall, educating women about breast health is a promising approach. ^{6 7 8 9 10}

Who Is on the Research Team?

Chaya Moskowitz, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adult women aged 25-49 who survived childhood cancer, were treated with chest radiation before turning 21, and haven't had breast imaging in the last two years. They must have been part of the CCSS cohort and not diagnosed with breast cancer or participated in Project VISION.

Inclusion Criteria

No mammogram or other breast imaging study in the 24 months prior to enrollment

I speak English and can participate in interviews over the phone.

I was diagnosed with cancer before I turned 21.

Exclusion Criteria

I have been diagnosed with breast cancer.

Participated in the Project VISION feasibility study (exposed to part of the intervention)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive mailed tailored print materials followed by a telephone-delivered Brief Motivational Interview

12 months

Follow-up

Participants are monitored for completion of mammogram screening and other health outcomes

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Questionnaire
• Survey

Trial Overview The study compares two methods to educate these women about their health risks and promote wellness, focusing on breast and heart health over a twelve-month period. It's designed specifically for those who received significant chest radiation as children.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

The EMPOWER intervention trial is a 12-month study of 360 women from the Childhood Cancer Survivor Study who have previously been treated with chest radiation, are 25 to 49 years of age at the time of enrollment, are 8 years or more since their chest radiation, and have not had a mammogram or other breast imaging study in the preceding two years. Following a baseline questionnaire, participants will be randomized to the attention control group (N=120) or the intervention group (N=240).

Group II: attention control group Active Control 1 Intervention

The EMPOWER intervention trial is a 12-month study of 360 women from the Childhood Cancer Survivor Study who have previously been treated with chest radiation, are 25 to 49 years of age at the time of enrollment, are 8 years or more since their chest radiation, and have not had a mammogram or other breast imaging study in the preceding two years. Following a baseline questionnaire, participants will be randomized to the attention control group (N=120) or the intervention group (N=240).

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

St. Jude Children's Research Hospital

Collaborator

Trials

451

Recruited

5,326,000+

Published Research Related to This Trial

A survey of 276 female breast cancer survivors revealed that only 8% discussed BRCA testing with healthcare providers, indicating a significant gap in communication about genetic testing options.

Only 26% of survivors demonstrated adequate knowledge about BRCA genes, suggesting that increasing education and discussions around genetic testing could empower survivors to make informed decisions regarding their health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic testing for breast cancer: where are health care providers in the decision process? Velicer, CM., Taplin, S.[2022]

A psychoeducational intervention (PEI) was developed to improve the uptake of genetic counseling among high-risk breast cancer survivors, based on feedback from 57 individuals with a personal or family history of breast cancer.

The final booklet, refined through focus group feedback, was found to be visually appealing and informative, suggesting it could effectively aid decision-making regarding genetic counseling in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From observation to intervention: development of a psychoeducational intervention to increase uptake of BRCA genetic counseling among high-risk breast cancer survivors. Vadaparampil, ST., Malo, TL., Nam, KM., et al.[2021]

The study developed the Wisconsin Survey of Diagnosis and Management in Breast Cancer (WiSDOM-B) to evaluate changes in breast cancer survivors' knowledge after receiving survivorship care plans (SCPs), involving 38 patients in a randomized pilot trial.

While there was a slight increase in knowledge after receiving SCPs (from 68.4% to 74.4%), this change was not statistically significant compared to the control group, indicating that while SCPs may enhance knowledge, their immediate impact may need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and evaluation of a survey to assess survivor knowledge change after survivorship care plans: WiSDOM-B (Wisconsin Survey of cancer DiagnOsis and Management in Breast cancer). Rocque, GB., Wisinski, KB., Buhr, KA., et al.[2022]

The My Guide smartphone application was found to be feasible and acceptable for use among Hispanic breast cancer survivors, with a high retention rate of 91.6% and an average usage time of 9.25 hours over 4 weeks.

Participants showed a significant increase in breast cancer knowledge after using the app, although improvements in health-related quality of life (HRQoL) were observed but not statistically significant, indicating potential for further research in a larger trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a Smartphone-based pilot intervention for Hispanic breast cancer survivors: a brief report. Buscemi, J., Buitrago, D., Iacobelli, F., et al.[2021]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4427075/

Impact of an educational intervention on provider knowledge ... An educational intervention detailing recommendations and counseling methods affected the knowledge and attitudes about breast cancer screening.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2589537023002717

Effectiveness of a telehealth patient education intervention ... These findings in conjunction with the findings of the present study suggest that patient education interventions are highly effective at improving cancer ...

4. journals.sagepub.com journals.sagepub.com/doi/10.1089/jwh.2024.0273

Effectiveness of Breast Density Educational Interventions ... Conclusion: Informational interventions targeting BD education alone are unlikely to significantly improve adherence to subsequent mammography among Latinas ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S154608432400169X

Revolutionizing Breast Cancer Screening: Integrating ... By integrating AI with clinical breast examination (CBE) and ultrasound imaging, these tools can improve the accuracy and efficiency of early breast cancer ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12242455/

Evidence-based digital health interventions for breast ... We conducted an umbrella review to summarize the evidence on digital health interventions aimed at improving health-related outcomes for BCS.

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04993313/standard-verbal-counseling-with-or-without-a-pictorial-educational-tool-for-the-reduction-of-psychological-morbidity-in-patients-with-stage-0-iiia-breast-cancer-receiving-radiation-therapy-cope-study

Standard Verbal Counseling With or Without a Pictorial ... This clinical trial studies the effect of standard verbal counseling with or without a pictorial educational tool for the reduction of ...

8. withpower.com withpower.com/trial/phase-breast-neoplasms-4-2017-35ec7

Educational Intervention for Breast Cancer Risk A breast cancer educational video (BCV) significantly improved knowledge about breast cancer in 62% of patients and reduced distress in 30% of those who ...

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

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 ...

10. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2818284

Screening for Breast Cancer: Evidence Report and ... Trials have established that screening mammography can reduce mortality risk, but optimal screening ages, intervals, and modalities for population screening ...