Decision Aid for Breast Cancer Surgery Choices

Recruiting at 57 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

627 Participants Needed

Trial Summary

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 data supports the effectiveness of the web-based decision aid treatment for breast cancer surgery choices?

Research shows that web-based decision aids can improve patients' knowledge about their surgical options and help them make more informed decisions. These aids have been effective in supporting women with early-stage breast cancer in understanding their treatment choices and improving decision quality. ^{1 2 3 4 5}

Is the Web-based decision aid for breast cancer surgery safe for humans?

The research does not specifically address safety concerns for the Web-based decision aid, but decision aids are generally considered safe as they are tools to help patients make informed choices about their treatment options. ^{2 4 5 6 7}

How does the Decision Aid for Breast Cancer Surgery Choices treatment differ from other treatments for breast cancer?

The Decision Aid for Breast Cancer Surgery Choices is unique because it provides personalized, web-based information to help women make informed decisions about their surgical options, such as breast-conserving therapy or mastectomy, before consulting with a surgeon. This approach supports patient knowledge and decision-making by offering tailored information during the critical period between diagnosis and surgical consultation. ^{1 2 8 9 10}

What is the purpose of this trial?

This trial studies how well a breast cancer surgery decision aid works in increasing patient engagement in decision making for patients with newly diagnosed stage 0-III breast cancer. The trial also examines barriers to patient engagement even with the use of a decision aid, and if barriers are more likely to be experienced by socioeconomically disadvantaged patients.

Research Team

Heather B. Neuman,, MD, MS

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

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

A Randomized Controlled Trial Evaluating the Impact of Web-Based Information on Breast Cancer Patients' Knowledge of Surgical Treatment Options. [2020]

2. Ireland pubmed.ncbi.nlm.nih.gov

Theory-based design and field-testing of an intervention to support women choosing surgery for breast cancer: BresDex. [2021]

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

Decision aids and breast cancer: do they influence choice for surgery and knowledge of treatment options? [2022]

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

A Decision Aid for Patients With Minimally Suspicious Screening Mammograms: A Pilot Study. [2022]

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

Efficacy of a decision aid in breast cancer patients considering immediate reconstruction: results of a randomized controlled trial. [2023]

6. Ireland pubmed.ncbi.nlm.nih.gov

Communicating side effect risks in a tamoxifen prophylaxis decision aid: the debiasing influence of pictographs. [2021]

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

Breast Reconstruction Decision Aids Decrease Decisional Conflict and Improve Decisional Satisfaction: A Randomized Controlled Trial. [2023]

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

A Randomized Controlled Trial Evaluating the BREASTChoice Tool for Personalized Decision Support About Breast Reconstruction After Mastectomy. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

[Interactive cd-rom on the choice between breast-sparing treatment and mastectomy: positive responses from patients and surgeons]. [2015]

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

Using the sociotechnical model to conduct a focused usability assessment of a breast reconstruction decision tool. [2023]