Education Program for Breast Cancer

Overseen By Ann Patridge, MD, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Must be taking: Endocrine therapy

Disqualifiers: Metastatic cancer, Pregnant, Prisoners, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new educational program for individuals beginning Endocrine Therapy, a common treatment for breast cancer. The goal is to determine if short videos can improve the therapy experience. Participants will either watch these videos weekly for six weeks or join a wait-list control group. Women who are about to start or have just started taking oral Endocrine Therapy, such as tamoxifen, and can use a computer are well-suited for this study. As an unphased trial, this study provides a unique opportunity to enhance the therapy experience through innovative educational support.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. It focuses on an education program for those starting or just started on Endocrine Therapy.

What prior data suggests that this education program is safe?

Research has shown that endocrine therapy is a common and generally well-tolerated treatment for breast cancer. However, adhering to the treatment plan can be challenging for some patients. Only about half complete the full five-year course, often due to side effects or the treatment's long duration.

Regarding safety, studies have found that the risk of breast cancer recurrence or new cancer development remains similar whether patients take breaks from their therapy or not. For example, one study found that about 8.9% of patients who paused their therapy experienced breast cancer events, compared to 9.2% of those who continued without breaks.

The new education program aims to help patients better understand and manage their endocrine therapy, potentially improving their experience and commitment to the treatment. The educational videos are safe and designed to provide information and support, not to replace medical treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Endocrine Therapy Education Program for breast cancer because it uniquely focuses on enhancing patient understanding and adherence to endocrine therapy. Unlike typical treatment options that primarily focus on the medical management of breast cancer, this program emphasizes education through weekly videos over six weeks, aiming to empower patients with knowledge. This approach could significantly improve treatment outcomes by ensuring patients understand their therapy, adhere to their treatment plan, and actively participate in their care.

What evidence suggests that the Endocrine Therapy Education Program is effective for improving experiences on Endocrine Therapy?

Research shows that hormone therapy effectively treats certain types of breast cancer. It can lower the risk of cancer recurrence by 40% and reduce the chance of dying from breast cancer by 30%. Studies also indicate that this therapy improves survival rates for people with specific types of breast cancer, such as ER-low positive, HER2-negative. However, about 30% of patients prescribed this treatment never start it. In this trial, participants in the Endocrine Therapy Education Intervention group will receive educational support to help them understand and follow their treatment, potentially improving their overall experience and outcomes. Meanwhile, the Wait-List Control Group will access the educational videos after completing initial surveys. ^{6 7 8 9 10}

Who Is on the Research Team?

Ann Partridge, MD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for individuals with breast cancer who are undergoing or about to start endocrine therapy. The study aims to help participants better understand and adhere to their treatment regimen.

Inclusion Criteria

Computer literacy (ability to watch videos and fill out questionnaires online)

I am biologically female.

English fluency for reading and writing

Exclusion Criteria

I am unable to give consent for myself.

Prisoners

Pregnant women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline

Participants complete a baseline visit and initial assessments

1 week

1 visit (in-person)

Intervention

Participants in Group A receive educational video once a week for 6 weeks; Group B waits for access

6 weeks

Weekly video sessions

Follow-up

Participants complete surveys at 6 weeks and 3 months to assess intervention impact

6 weeks

2 surveys (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Endocrine Therapy Education Program

Trial Overview The focus of the trial is on a video-based Endocrine Therapy Education Program designed to enhance patients' understanding of their therapy, potentially improving adherence and overall experience.

How Is the Trial Designed?

Group I: Group A: Endocrine Therapy Education Intervention Experimental Treatment 1 Intervention

Participants will complete: * Baseline visit. * Educational video once a week for 6 weeks. * 6-week survey. * 3-month survey.

Group II: Group B: Wait-List Control Group Active Control 1 Intervention

Participants will complete: * Baseline visit. * 6-week survey. * 3-month survey. * Access to intervention educational videos. * 2-week post video survey.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7430212/

How patients experience endocrine therapy for breast cancer Despite the known efficacy of ET, up to 30% of patients with invasive HR+ breast cancer who are prescribed ET never initiate therapy [9]. In ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa1701830

20-Year Risks of Breast-Cancer Recurrence after Stopping ... After 5 years of adjuvant endocrine therapy, breast-cancer recurrences continued to occur steadily throughout the study period from 5 to 20 years.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10453164/

Extended Adjuvant Endocrine Therapy in Early Breast ... Taking tamoxifen for 5 years has been shown to reduce the risk of breast cancer recurrence by 40% and mortality by 30% compared to patients ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e12516

The impact of adjuvant endocrine therapy on outcomes in ... This study demonstrates that endocrine therapy significantly improves survival outcomes in patients with ER-low positive, HER2-negative breast cancer.

5. nature.com nature.com/articles/s41523-025-00746-7

Impact of endocrine therapy regimens for early-stage ER+ ... For postmenopausal women with breast cancer, the 25-year cumulative risk of contralateral breast cancer was reduced by 6–10% for the 10-year ...

6. nejm.org nejm.org/doi/full/10.1056/NEJMoa2212856

Interrupting Endocrine Therapy to Attempt Pregnancy after ... The 3-year incidence of breast cancer events was 8.9% (95% confidence interval [CI], 6.3 to 11.6) in the treatment-interruption group and 9.2% ( ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11649036/

Adherence to endocrine therapy in breast cancer adjuvant ... In contrast, adherence to adjuvant therapy in clinical practice is relatively poor, with only about 50% of women successfully completing five years therapy.

8. dana-farber.org dana-farber.org/newsroom/news-releases/2023/international-study-shows-many-younger-women-with-breast-cancer-can-safely-have-a-baby

International study shows many younger women with ... The three-year rate of recurrence was 8.9%, similar to the 9.2% rate in an external group of patients who had not paused their endocrine therapy ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT02308085

Study Details | NCT02308085 | Pregnancy Outcome and ... For women desiring pregnancy after a breast cancer, 5-10 years of endocrine therapy may substantially reduce the chance of conception; however, a shorter ...

10. bcrf.org bcrf.org/blog/positive-trial-breast-cancer-pregnancy/

POSITIVE Trial Breast Cancer Seventy-four percent of the women in the trial successfully got pregnant and a little more than 63 percent gave birth. The study noted that a ...