Educational Intervention for Cancer Survivors' Breast Cancer Screening

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

360 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to empower women to improve their health in two very important areas: breast and heart health. This twelve-month study will compare two methods of informing participants about potential health risks and ways to stay healthy. The EMPOWER Study has been designed for adult women who were treated for a childhood cancer with chest radiation.

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 involving Questionnaire, Pictorial Educational Tool, Verbal Counseling Tool, and Survey for cancer survivors' breast cancer screening?

Research suggests that personalized survivorship care plans can improve cancer-related knowledge, as seen in a study where breast cancer survivors showed a slight increase in knowledge after receiving such plans. Additionally, clinician-led interviews have been shown to boost self-efficacy, which is the confidence in managing one's own care, indicating that educational interventions can be beneficial. ^{1 2 3 4 5}

Is the educational intervention for cancer survivors' breast cancer screening safe?

The research articles do not provide specific safety data for the educational intervention, but they do not report any safety concerns or adverse effects related to the use of educational tools, surveys, or counseling in cancer survivors. ^{1 6 7 8 9}

How is the educational intervention for breast cancer survivors' screening different from other treatments?

This educational intervention is unique because it focuses on increasing the uptake of genetic counseling and testing among high-risk breast cancer survivors through a psychoeducational approach. It uses specially designed materials to help survivors understand their genetic risk and make informed decisions about follow-up screening, which is different from traditional medical treatments that focus on physical health. ^{2 10 11 12 13}

Research Team

Chaya Moskowitz, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

I was diagnosed with cancer before I turned 21.

I have received more than 20 Gy of radiation therapy to my chest area.

Exclusion Criteria

I have been diagnosed with breast cancer.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

References

1. England 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). [2022]

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

Improving breast cancer survivors' knowledge using a patient-centered intervention. [2018]

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

Exploring patient-physician communication in breast cancer care for African American women following primary treatment. [2022]

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

Provision of a personalized survivorship care plan and its impact on cancer-related health literacy among childhood cancer survivors in Hong Kong. [2023]

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

The role of a clinician-led reflective interview on improving self-efficacy in breast cancer survivors: a pilot study. [2021]

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

Genetic testing for breast cancer: where are health care providers in the decision process? [2022]

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

Knowledge, attitudes, risk perception, and cancer screening behaviors among cancer survivors. [2015]

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

Efficacy of an educational material on second primary cancer screening practice for cancer survivors: a randomized controlled trial. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Breast Cancer Survivorship Care: Targeting a Colorectal Cancer Education Intervention. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Effects of breast health education conducted by trained breast cancer survivors. [2022]

11. England pubmed.ncbi.nlm.nih.gov

A randomized controlled intervention to promote readiness to genetic counseling for breast cancer survivors. [2020]

12. England 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. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Feasibility of a Smartphone-based pilot intervention for Hispanic breast cancer survivors: a brief report. [2021]