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

Trial Summary

What is the purpose of this trial?

This is a study to assess the feasibility and acceptability of a novel decision aid (DA) in a newly diagnosed, early-stage breast cancer population. Insights gained from patient feedback and the implementation process will be used to improve the information delivered in the decision aid itself and to plan for a larger scale trial to compare the decision aid to standard of care.

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 data supports the effectiveness of the Decision Aid treatment for breast cancer?

Research shows that decision aids help patients understand their treatment options and involve them in making decisions about their care. This is especially important for breast cancer patients, as it can improve their understanding and satisfaction with their treatment choices. ^{1 2 3 4 5}

Is the Decision Aid for breast cancer safe for humans?

The research articles focus on the development, acceptability, and quality of decision aids for breast cancer treatment, but they do not provide specific safety data for humans. ^{2 3 6 7 8}

How is the Decision Aid treatment for breast cancer different from other treatments?

The Decision Aid (DA) for breast cancer is unique because it helps patients make informed choices about their treatment options by providing clear, balanced information and supporting shared decision-making, rather than being a direct medical treatment itself. ^{2 3 4 9 10}

Research Team

Sarah Tevis, MD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Development and evaluation of a decision aid for patients considering first-line chemotherapy for metastatic breast cancer. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Assessing the quality and communicative aspects of patient decision aids for early-stage breast cancer treatment: a systematic review. [2020]

3. United States 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. [2019]

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

Development of patients' decision aid for older women with stage I breast cancer considering radiotherapy after lumpectomy. [2019]

5. Ireland pubmed.ncbi.nlm.nih.gov

Impact of decision aids in a sustained implementation at a breast care center. [2022]

6. Netherlands 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. [2021]

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

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

8. England pubmed.ncbi.nlm.nih.gov

A decision aid to assist in adjuvant therapy choices for breast cancer. [2013]

9. England pubmed.ncbi.nlm.nih.gov

Development of a patient decision aid for choice of surgical treatment for breast cancer. [2023]

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

Evaluate the effectiveness of breast cancer decision aids: A systematic review and meta-analysis of randomize clinical trails. [2021]