Decision Aid for Breast Cancer Surgery Choices

Not currently recruiting at 61 trial locations

Overseen By Heather B. Neuman, MD, MS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Alliance for Clinical Trials in Oncology

Disqualifiers: Dementia, Memory loss, Hearing impairment, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a web-based tool designed to assist patients with newly diagnosed stage 0-III breast cancer in making informed decisions about their surgery options. Researchers aim to determine if the tool increases patient engagement in the decision-making process. They are also investigating whether individuals from disadvantaged backgrounds encounter more challenges despite this aid. Suitable candidates for this trial are those planning breast surgery as part of their treatment and who are comfortable discussing their options in English. As an unphased study, this trial allows patients to contribute to research that could improve decision-making tools for future breast cancer patients.

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

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

What prior data suggests that this decision aid is safe for patients with breast cancer?

Research has shown that online decision-making tools are generally safe and easy to use. Studies indicate they can increase breast cancer patients' satisfaction with their surgery choices, leading to greater confidence in their decisions. One study found that these tools can also enhance decision-making quality after a mastectomy. No reports have indicated any problems caused by these online tools, which are designed to assist patients without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the web-based decision aid for breast cancer surgery choices because it offers a personalized approach to help patients make informed decisions about their treatment options. Unlike the traditional method, where patients rely mainly on in-person consultations with their surgeons, this digital tool provides tailored information and support before the surgical consultation. This innovative approach empowers patients by giving them more time to understand their choices, potentially reducing anxiety and leading to more satisfactory treatment outcomes.

What evidence suggests that this web-based decision aid is effective for increasing patient engagement in breast cancer surgery choices?

Research has shown that online tools can assist breast cancer patients in making surgical decisions. In this trial, participants in one arm will receive a web-based decision aid before their surgical consultation. Several studies have found that these tools increase satisfaction with decisions, enhancing patients' confidence and clarity about their choices. One study found that patients using an online tool felt less uncertain about their decisions. Another study demonstrated that these tools offer benefits beyond regular care, improving the quality of decision-making. Overall, online tools help patients make informed choices about their breast cancer treatment. ^{1 2 4 6 7}

Who Is on the Research Team?

Heather B. Neuman,, MD, MS

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for English-speaking patients newly diagnosed with stage 0-III breast cancer who are planning surgery as part of their treatment. Surgeons and care staff at participating clinics must consent to the study. Patients with impaired decision-making capacity or hearing impairment requiring an interpreter are excluded.

Inclusion Criteria

You were recently diagnosed with early-stage breast cancer.

Doctors, nurses, assistants, and other healthcare providers who help treat people with newly diagnosed breast cancer at the clinic.

Eligible patients must be planning breast surgery as a component of their definitive treatment

Exclusion Criteria

Hospitals that do not perform surgery on 120-300 new breast cancer patients each year.

Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study

Patients with hearing impairment requiring the use of an interpreter are not eligible for this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Usual Care

Participants receive care as per usual practice before institutional crossover

10 weeks

Decision Aid Intervention

Participants receive a web-based decision aid prior to surgical consultation after institutional crossover

10 weeks

Follow-up

Participants are monitored for patient engagement and knowledge post-surgical consultation

3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Web-based decision aid

Trial Overview The study compares usual care against a web-based decision aid designed to increase patient engagement in surgical decisions for breast cancer. It also explores barriers to engagement, particularly among socioeconomically disadvantaged patients.

How Is the Trial Designed?

Group I: Arm II (web-based breast cancer surgery decision aid) Experimental Treatment 2 Interventions

Following a 10 week implementation period, at the time of institutional crossover, participants will receive a web-based decision aid prior to the surgical consultation..

Group II: Arm I (surgical consultation) Active Control 1 Intervention

Prior to institutional crossover, participants receive care as per usual care.

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Recruited

224,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12060549/

Effects of a web-based decision aid on breast cancer patients ... The current study demonstrated that WDAs effectively improved decision satisfaction in patients requiring breast cancer surgery, a finding ...

2. academic.oup.com academic.oup.com/bjs/article/112/8/znaf151/8222685

Effectiveness of a patient decision aid for women considering ... This RCT evaluated whether an online patient decision aid provided additional benefits over high-quality standard care in supporting ...

3. jmir.org jmir.org/2024/1/e53872/

Assessing the Content and Effect of Web-Based Decision ... Web-based decision aids have been shown to have a positive effect when used to improve the quality of decision-making for women facing postmastectomy breast ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2809976

Effectiveness of a Decision Aid Plus Standard Care in ... Conclusions and Relevance The results of this study demonstrated lower decisional conflict as measured by DCS score following use of the online, ...

5. journals.lww.com journals.lww.com/plasreconsurg/fulltext/2024/10000/efficacy_of_a_decision_aid_in_breast_cancer.3.aspx

Efficacy of a Decision Aid in Breast Cancer Patients... Conclusions: The authors' online decision aid was as effective in reducing decisional conflict as an information leaflet about immediate BR after mastectomy. ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03791138

The Impact of a Web-based Patient Decision Aid ... This study evaluates the impact of an online patient decision aid on the process of decision making regarding breast reconstruction and the decision quality ...

7. becarispublishing.com becarispublishing.com/doi/10.2217/cer-2020-0052

Web-based decision aids to support breast cancer ... Conclusion: This analysis showed the positive effect of web-based DAs on patient-centered outcomes in breast cancer screening. In the future, ...