Decision Aid for Breast Cancer

Recruiting at 2 trial locations

Overseen By Jakob Durden, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Prior consultation, Previous cancer, Neoadjuvant chemotherapy

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool to assist women with newly diagnosed, early-stage breast cancer in making treatment decisions. The tool, known as a decision aid (DA), provides clear and helpful information about surgical options like lumpectomy and mastectomy. Some participants will use this decision aid, while others will receive a standard educational pamphlet. Women diagnosed with stage 0-III breast cancer who are considering surgery but have not yet had a surgical consultation are ideal candidates for this trial. As an unphased trial, this study offers participants the chance to contribute to research that could enhance decision-making tools for future 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. It seems focused on decision-making tools rather than medication changes.

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

A previous study demonstrated that a decision aid (DA) helped women make informed choices about their breast cancer treatment. These aids provide clear information, enabling patients to understand their options without causing harm. Research has shown that using a decision aid does not result in any physical side effects. It serves as a tool to guide decisions and enhance understanding. Studies of decision aids for breast cancer have reported no negative effects, suggesting that the decision aid is safe and well-tolerated for assisting patients in making informed decisions about their care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Decision Aid (DA) because it aims to empower patients with early-stage breast cancer by providing personalized and accessible information. Unlike standard educational materials that broadly discuss surgical options, the DA is an electronic tool that helps patients understand their specific situation, the risks, and benefits of different treatments, and guides them in making informed decisions. This tailored approach could lead to better patient satisfaction and outcomes by ensuring decisions align with personal values and preferences.

What evidence suggests that this decision aid is effective for breast cancer?

Research has shown that decision aids can help breast cancer patients make better treatment choices. In this trial, participants in the interventional group will receive a decision aid, which studies have found increases certainty and reduces uncertainty. In one study, patients who used a decision aid felt more informed and confident about their treatment options. Other research has demonstrated that decision aids improve the quality of decision-making and overall health outcomes. Overall, decision aids effectively help patients understand their treatment options more clearly and with less stress. ^{3 4 5 6 7}

Who Is on the Research Team?

Sarah Tevis, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for individuals newly diagnosed with early-stage breast cancer. The study aims to include those who are evaluating their surgical treatment options and can provide feedback on the decision aid being tested.

Inclusion Criteria

I am a candidate for both breast-conserving surgery and complete removal.

English speaking

I am a woman aged between 18 and 100.

Exclusion Criteria

I have discussed surgical options for my breast cancer with a surgeon.

I need chemotherapy before surgery.

I have had breast cancer before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either the novel decision aid or an alternative educational pamphlet

1 year

Follow-up

Participants are monitored for engagement and feedback on the decision aid

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Decision Aid (DA)

Trial Overview The study is testing a novel decision aid designed to help patients understand and choose between surgical treatments, comparing its effectiveness and user experience against the standard of care.

How Is the Trial Designed?

Group I: Interventional Group Experimental Treatment 1 Intervention

Newly detected, early stage breast cancer patients in the treatment group will be provided an electronic copy of the DA for their reference via email.

Group II: Control Group Placebo Group 1 Intervention

Newly diagnosed, early stage breast cancer patients in the control group will be provided an electronic copy of an alternative educational pamphlet discussing surgical options for breast cancer.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Association of Academic Surgery

Collaborator

Trials

1

Recruited

60+

Published Research Related to This Trial

Decision aids significantly reduced treatment decision conflicts for breast cancer patients compared to conventional methods, indicating they can help patients feel more confident in their treatment choices.

However, decision aids did not significantly impact screening decision conflicts or other factors like anxiety, decision regret, and satisfaction, suggesting their effectiveness may be limited to specific decision-making scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluate the effectiveness of breast cancer decision aids: A systematic review and meta-analysis of randomize clinical trails. Gao, JP., Jin, YH., Yu, SF., et al.[2021]

A decision aid (DA) prototype was developed and positively received by 12 women over 70 with Stage I breast cancer, indicating it is clear and acceptable for helping them understand treatment options.

Participants found the DA helpful for making treatment decisions and recommended its use in clinical practice, highlighting the need for better decisional support for older patients in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Working Toward a Decision: The Development and First Impressions of a Decision Aid for Older Women with Early-stage Breast Cancer. D'Alimonte, L., Angus, J., Wong, J., et al.[2019]

A decision aid (DA) designed for women aged 70 and older with Stage I ER+/HER2-negative breast cancer was found to be very helpful, with 94% of participants agreeing it prepared them for treatment decisions.

The DA significantly improved participants' knowledge about their condition, increasing correct responses from an average of 9.0 to 10.6 out of 14 questions, indicating its potential effectiveness in supporting informed decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of a patient decision aid for women aged 70 and older with stage I, estrogen receptor-positive, HER2-negative breast cancer. Minami, CA., Freedman, RA., Karamourtopoulos, M., et al.[2021]

The Adjuvant! decision aid significantly influenced treatment choices for breast cancer patients, with 13.3% of patients opting out of adjuvant therapy after using the tool, indicating its effectiveness in facilitating informed decision-making.

Over 95% of patients found the decision aid easy to understand, and 81.4% of physicians reported it was useful for understanding patient preferences, highlighting its acceptability and potential to enhance patient-physician communication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A decision aid to assist in adjuvant therapy choices for breast cancer. Siminoff, LA., Gordon, NH., Silverman, P., et al.[2013]

A patient decision aid (PtDA) was developed for older women with Stage I, estrogen receptor-positive breast cancer, which helped them understand the benefits and risks of adjuvant radiotherapy after lumpectomy, leading to improved treatment-related knowledge.

After using the PtDA, participants reported a significant reduction in decisional conflict and increased clarity regarding their treatment options, suggesting that the PtDA effectively supports informed decision-making in this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of patients' decision aid for older women with stage I breast cancer considering radiotherapy after lumpectomy. Wong, J., D'Alimonte, L., Angus, J., et al.[2019]

The distribution of decision aids (DAs) to 1098 breast cancer patients significantly increased their knowledge and reduced decisional conflict, indicating that these tools are effective in supporting patient decision-making.

Patients with lower baseline knowledge, higher decisional conflict, and those of Hispanic ethnicity showed the most significant improvements, suggesting that targeted use of DAs could further enhance their effectiveness for specific groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of decision aids in a sustained implementation at a breast care center. Belkora, JK., Volz, S., Teng, AE., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37815283/

Efficacy of a Decision Aid in Breast Cancer Patients ... The authors evaluated the efficacy of an online decision aid in improving the decision-making process, decision quality, and health outcomes in breast cancer ...

2. 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, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8363361/

Evaluate the effectiveness of breast cancer decision aids We included 22 studies. Compared with the conventional methods, decision aids reduced treatment decision conflicts and had no significant effect on screening ...

4. 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... ... The authors evaluated the efficacy of an online decision aid in improving the decision-making process, decision quality, and health outcomes in breast cancer ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02823262

A Breast Cancer Treatment Decision Aid for Women Aged ... The Decision Aid (DA) was created for women 70 years or older diagnosed with ER+, HER2-, clinically LN-, 3cm or less breast cancers deciding on breast cancer ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5060163/

Development and evaluation of a breast cancer prevention ... Objective To develop and evaluate the effectiveness of a breast cancer prevention decision aid for women aged 50 and older at higher risk of breast cancer.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0960977623007397

Development and evaluation of a decision aid for women ... Decision aids (DA) can help individuals gain knowledge about breast screening to enable them to make informed decisions consistent with their personal ...