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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a decision-making tool can assist individuals with newly diagnosed early-stage breast cancer in deciding whether to undergo a contralateral prophylactic mastectomy (removal of the healthy breast to prevent cancer). The tool supports patients in understanding their surgical options and making informed choices. Participants will use the tool during their consultation with a breast cancer surgeon and will complete questionnaires before and after the visit. The trial seeks participants who have been diagnosed with ductal breast carcinoma in situ (a non-invasive cancer) or stage I-III breast cancer in one breast and who can read and write in English. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance decision-making tools for future patients.

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 prior data suggests that this decision making tool is safe for patients with breast cancer?

Research has shown that tools for making decisions about breast cancer treatment are safe. Studies have found that these tools improve patient-doctor communication and aid in decision-making. Designed to guide patients without causing harm, these tools have been used by many women in past reviews to plan their cancer treatment without safety issues. Since the focus is on helping patients understand their options rather than on medical procedures, there are no physical side effects. Overall, these tools are well-received and useful in decision-making. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Decision Making Tool for breast cancer because it aims to empower patients during their consultations with breast cancer surgeons. Unlike traditional treatment options that focus solely on medical interventions like surgery or chemotherapy, this tool is designed to enhance patient engagement and understanding. By using this tool, patients can make more informed decisions about their treatment options, potentially leading to better outcomes and satisfaction. This approach highlights the importance of patient-centered care in the treatment journey.

What evidence suggests that this decision making tool is effective for supporting surgical decisions in breast cancer patients?

Research has shown that decision-making tools can greatly assist breast cancer patients. In this trial, participants will use a decision-making tool during consultations with their breast cancer surgeon. Studies have found that these tools enhance patients' understanding of their options, leading to more informed decisions. One study revealed that patients who used a decision aid felt more satisfied with their decisions and better prepared for surgery. Another review found that decision aids increased patient knowledge and reduced uncertainty. Overall, these tools help patients make choices that align with their personal values and preferences. ^{6 7 8 9 10}

Who Is on the Research Team?

Abenaa M Brewster

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

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Evaluate the effectiveness of breast cancer decision aids To assess the effectiveness of decision aids in the treatment, prevention and screening of breast cancer patients. A systematic review and meta‐analysis.

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Effectiveness of a Decision Aid Plus Standard Care in ... This randomized clinical trial evaluates the effect of a decision-making aid and patient preference assessment tool in surgical ...

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Clinical Decision Support Systems in Breast Cancer This systematic review examines various CDSSs to determine their availability, intended use, medical characteristics, and expected outputs concerning breast ...

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Improving value-concordant shared decision making through ... In breast cancer surgical care, pDAs have been shown to increase patient knowledge, improve patient satisfaction with decision, lower pain scores, and improve ...

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Shared decision making with breast cancer patients The objective of this trial was to investigate whether the Decision Helper (DH), an in-consultation patient decision aid, increases patient ...

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Development and evaluation of a breast cancer prevention ... The decision aid shows promise as a useful decision support tool in preparing these women for discussion with breast health practitioners. Subsequent ...

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Effects of a web-based decision aid on breast cancer patients ... This study demonstrated that WDAs optimize the shared decision-making process and promote information sharing. A WDA is a convenient tool for ...

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A scoping review of interactive and personalized web ... ... tool for clinical decision-making ... breast cancer prognosis prediction tool in 45,789 patients using Scottish Cancer Registry data.

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Effect of decision aid for breast cancer prevention on ... The subjects' decision predispositions were measured using a choice predisposition tool. 23. O'Connor A, Jacobsen MJ, Stacey D. Ottawa Personal Decision Guide.

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Effect of a Mammography Screening Decision Aid ... Use of a mammography screening decision aid may help women 75 years and older make more informed decisions about mammography screening and, as a result, may ...