Decision Making Tool for Breast Cancer

Overseen By Abenaa M Brewster

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Previous breast cancer, Bilateral mastectomy, BRCA mutation, others

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

Compensation: Varies

Number of Visits: Unknown

15 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the Decision Making Tool for Breast Cancer treatment?

Research shows that decision aids, like the Decision Making Tool for Breast Cancer, help patients participate more in decision making and make higher-quality decisions by providing them with the latest scientific evidence and aligning with their personal values. ^{1 2 3 4 5}

How does this treatment differ from other breast cancer treatments?

This treatment is unique because it uses a computer-based tool to help women with breast cancer make informed decisions about adjuvant therapy (additional treatment given after the primary treatment). It provides personalized information on the potential benefits and risks of adjuvant therapy, helping patients understand their individual risk of breast cancer-related mortality and how treatment might improve their survival. ^{1 4 6 7 8}

What is the purpose of this trial?

This trial studies the acceptability and how well decision making tool works in supporting decision making in contralateral prophylactic mastectomy in patients with newly diagnosed breast cancer. Decision making tool may help patients with early stage breast cancer make decisions regarding their surgical options.

Research Team

Abenaa M Brewster

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for English-speaking individuals newly diagnosed with early-stage breast cancer (DCIS or stage I-III) who haven't had previous breast cancers, bilateral mastectomies, known genetic mutations like BRCA1/2, or a strong family history of cancer.

Inclusion Criteria

Able to speak read or write English

Newly diagnosed ductal breast carcinoma in situ (DCIS) or stage I-III sporadic unilateral invasive breast cancer

Exclusion Criteria

You have had breast cancer in the past.

You had surgery to remove both breasts as a preventive measure.

You have a gene mutation that makes you more likely to develop breast cancer or a strong family history of cancer that puts you at high risk for developing breast cancer in the other breast.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Consultation and Decision Support

Participants use the decision making tool during consultation with a breast cancer surgeon and complete questionnaires before and after consultation

1-2 weeks

Follow-up

Participants are monitored for changes in decisional conflict and knowledge about CPM, as well as the acceptability of the decision support tool

Up to 2 years

Treatment Details

Interventions

• Decision Making Tool

Trial Overview The study is evaluating the effectiveness of a decision-making tool designed to help patients understand their surgical options and make informed choices about contralateral prophylactic mastectomy.

Participant Groups

Group I: Supportive care (decision making tool) Experimental Treatment 2 Interventions

Patients use decision making tool during consultation with breast cancer surgeon and complete questionnaires before and after consultation.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

The Consultation Planning Template and Consultation Recording Template have been shown to enhance the quality of breast cancer treatment decisions and improve communication between patients and healthcare providers, as demonstrated in clinical trials.

These templates can be adapted for various clinical settings, providing nurses with practical tools to support patients in making informed decisions about their treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the quality of decision making in breast cancer: consultation planning template and consultation recording template. Sepucha, KR., Belkora, JK., Aviv, C., et al.[2019]

A systematic review of 23 randomized trials found that cancer patient decision aids significantly improve patient participation in decision making and lead to higher-quality decisions regarding treatment options.

Effective strategies to enhance shared decision making include training clinicians, using question prompt sheets, and providing decision coaching, which can help address patients' knowledge gaps and unrealistic expectations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision making in oncology: a review of patient decision aids to support patient participation. Stacey, D., Samant, R., Bennett, C.[2022]

The implementation of a decision support tool (DST) for cancer treatment showed little effect on overall survival (OS) among 1,059 patients with breast, colorectal, and lung cancer, indicating that process improvements may not lead to better patient outcomes.

Despite high adherence to evidence-based treatment recommendations (over 90% after DST implementation), the largest survival benefit observed was only 1.7 months for lung cancer patients, suggesting that existing treatment practices were already effective prior to the DST's introduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival After Implementation of a Decision Support Tool to Facilitate Evidence-Based Cancer Treatment. Ojha, RP., Lu, Y., Narra, K., et al.[2023]

Internet tools significantly enhance decision-making for physicians treating breast cancer by providing data-driven estimates on chemotherapy necessity, expected toxicity, and patient life expectancy based on large patient datasets.

These tools not only assist healthcare providers but also empower patients and caregivers by clearly outlining the benefits and risks of various treatment options, leading to more informed choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet tools to enhance breast cancer care. Shachar, SS., Muss, HB.[2022]

The study identified three clinical prediction tools (Adjuvant!Online, PREDICT, and CancerMath) for assessing prognosis in early breast cancer, but none provided comprehensive information on competing risks from age and comorbidities, which are crucial for informed decision-making.

A newly developed decision aid (DA) was pilot-tested with 20 women and showed a high comprehension rate of 90.5% among 102 participants in an online survey, indicating that patients can effectively understand individual prognosis information when presented clearly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communicating prognosis to women with early breast cancer - overview of prediction tools and the development and pilot testing of a decision aid. Mühlbauer, V., Berger-Höger, B., Albrecht, M., et al.[2020]

A computer-based tool has been developed to help women with primary breast cancer understand their risk of mortality without adjuvant therapy and how much this risk can be reduced with such treatment.

The tool uses life table analysis to project outcomes based on individual patient data, facilitating informed discussions between patients and physicians about the benefits of adjuvant therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A computer based program to assist in adjuvant therapy decisions for individual breast cancer patients. Ravdin, PM.[2009]

The Interactive Breast Cancer CDROM did not change the treatment decisions of patients with early-stage breast cancer, but it significantly increased their satisfaction with the information received and the decision-making process over a 9-month period.

Patients using the CDROM reported better quality of life outcomes, including improved physical functioning, less pain, and fewer arm symptoms, indicating that while it didn't alter treatment choices, it positively impacted their overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision support for patients with early-stage breast cancer: effects of an interactive breast cancer CDROM on treatment decision, satisfaction, and quality of life. Molenaar, S., Sprangers, MA., Rutgers, EJ., et al.[2017]

Decision aids, such as educational booklets and videos, significantly improved patient involvement in surgical decision-making for early-stage breast cancer, leading to better decision-related outcomes.

After using decision aids, many patients opted for more aggressive surgical options like mastectomy instead of breast-conserving surgery, indicating that these tools can influence treatment choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision aids on breast conserving surgery for early stage breast cancer patients: a systematic review. Si, J., Guo, R., Lu, X., et al.[2021]

References

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

Improving the quality of decision making in breast cancer: consultation planning template and consultation recording template. [2019]

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

Decision making in oncology: a review of patient decision aids to support patient participation. [2022]

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

Survival After Implementation of a Decision Support Tool to Facilitate Evidence-Based Cancer Treatment. [2023]

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

Internet tools to enhance breast cancer care. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Communicating prognosis to women with early breast cancer - overview of prediction tools and the development and pilot testing of a decision aid. [2020]

6. France pubmed.ncbi.nlm.nih.gov

A computer based program to assist in adjuvant therapy decisions for individual breast cancer patients. [2009]

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

Decision support for patients with early-stage breast cancer: effects of an interactive breast cancer CDROM on treatment decision, satisfaction, and quality of life. [2017]

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

Decision aids on breast conserving surgery for early stage breast cancer patients: a systematic review. [2021]