Decision Support Tools for Breast Cancer

Age: 65+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on creating and testing a decision support tool for women with early-stage breast cancer (stages I-III) who are considering chemotherapy. The tool helps patients and doctors understand the risks and benefits of chemotherapy, facilitating joint decision-making on treatment options. Women diagnosed with stage I-III breast cancer within the last three months and considering chemotherapy are suitable candidates for this trial. Participants will either use the decision support tool or engage in discussions and questionnaires to refine it. As an unphased trial, this study allows participants to contribute to developing a valuable tool that could enhance decision-making 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 focuses on decision-making for chemotherapy in breast cancer patients.

What prior data suggests that this decision support tool is safe for use in breast cancer treatment decision-making?

Research has shown that decision support tools for breast cancer are generally safe for patients. These tools assist patients and doctors in making better treatment choices. One study examined a tool that provides personalized information and helps predict treatment risks. Another study found that a similar tool improved communication about treatment options and risks.

These tools typically include written information, videos, or questionnaires to aid decision-making. No reports of harmful effects have emerged from using these tools. They are designed to help understand treatment choices, not to treat the cancer directly. Therefore, they are considered very safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it introduces a personalized decision support tool that could transform how patients navigate breast cancer treatment options. Unlike standard treatments, which focus solely on medical intervention, this tool provides educational materials tailored to each patient, helping them make informed decisions. By incorporating written information, graphics, videos, and more, it empowers patients to engage actively in their treatment journey, potentially improving satisfaction and outcomes.

What evidence suggests that this decision support tool is effective for breast cancer decision-making?

Research has shown that decision support tools can guide breast cancer treatment choices. These tools use medical data to provide personalized information, simplifying the understanding of treatment options. In this trial, participants in the intervention arm will use a decision support tool designed to aid in selecting the appropriate treatment steps for breast cancer. Studies have found that tools like CureMate assist in this process. For example, an online decision tool for a specific type of breast cancer reduced users' estimated risk of dying within 10 years from 9% to 3%. Overall, these tools aim to help patients and doctors make informed decisions together. ^{2 3 4 6 7}

Who Is on the Research Team?

Meghan Karuturi

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for older women aged 65 or above who have been diagnosed with Stage I-III breast cancer and are within 3 months of deciding on neoadjuvant or adjuvant chemotherapy. Participants must be able to read and speak English, have no visual or auditory deficits, and their physician must agree to take part in the study.

Inclusion Criteria

I am eligible for chemotherapy or targeted therapy for my HER2+ breast cancer.

I decided on my breast cancer chemotherapy plan within the last 3 months.

I was diagnosed with early to locally advanced breast cancer.

Exclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Interviews and Questionnaires

Participants undergo interviews and complete questionnaires to assess decision-making needs and preferences

1-2 hours per session

1 visit (in-person or virtual)

Decision Support Tool Development

Development and testing of a decision support tool for chemotherapy decision-making

6-12 months

Field Testing

Field testing of the decision support tool to demonstrate feasibility and acceptability

3-6 months

Follow-up

Participants are monitored for the effectiveness of the decision support tool

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Decision Support Tool

Trial Overview The study aims to understand decision-making needs of these women by conducting interviews, discussions, and questionnaires. The goal is to create a support tool that helps patients and doctors make informed decisions about chemotherapy treatment options.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 3 Interventions

Participants in the intervention arm only will then be asked to look at the decision tool that includes educational materials about the diagnosis and treatment of breast cancer. These could be written information, graphics, videos, animations, or questionnaires. This decision tool will personalize the decision to you specifically and support your decision-making process

Group II: Non-Intervention Arm Active Control 1 Intervention

Participants undergo interviews and complete questionnaires over 1-2 hours. Patients and physicians also participate in a discussion and complete shared decision-making questionnaire over 15-30 minutes.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

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]

A 50-year-old breast cancer patient experienced significant adverse effects from tamoxifen, including hot flushes, hyperhidrosis, urinary frequency, and depression, which negatively impacted her quality of life.

After 25 days of treatment with traditional Korean herbal medicine and acupuncture, the patient's symptoms improved significantly, indicating that these interventions may help alleviate tamoxifen-induced side effects in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Traditional Korean medicine treatment for tamoxifen associated adverse events of breast cancer patient: A CARE - Compliant case report. Seo, J., Lee, D., Jo, HG.[2021]

In a study of 139 breast cancer patients undergoing chemotherapy, using a mobile app for symptom tracking improved the stabilization of daily functional activity when patients reviewed their data with a physician, compared to those who used the app unsupervised.

Patients using the app reported more adverse events than those using traditional questionnaires, indicating that the app enhances awareness and reporting of chemotherapy side effects, particularly when used in a supervised setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile App to Stabilize Daily Functional Activity of Breast Cancer Patients in Collaboration With the Physician: A Randomized Controlled Clinical Trial. Egbring, M., Far, E., Roos, M., et al.[2022]

A systematic review of 15 studies found that Decision Support Systems (DSS) were effective in reducing worst and usual pain scores for cancer patients, indicating some benefit in symptom management during and after treatment.

However, DSS interventions showed mixed results for improving overall health-related outcomes like quality of life and depression, highlighting the need for better evaluation methods to understand their full impact on patient-reported outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of cancer clinical decision support systems on patient-reported outcomes: A systematic review. Pitt, E., Bradford, N., Robertson, E., et al.[2023]

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]

Clinicians identified a need for standardized decision support tools to better assess breast cancer risk, particularly for women at moderate risk, as current tools are lacking.

Participants emphasized that any new tool should be evidence-based, easily accessible, and present absolute risk in various formats, while also being mindful of the potential to cause anxiety in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing and managing breast cancer risk: clinicians' current practice and future needs. Collins, IM., Steel, E., Mann, GB., et al.[2022]

The study involved 12 women aged 38-68 who shared their experiences with decisional support aids during their breast cancer journey, highlighting the emotional stress and urgency they felt in making treatment decisions.

Key themes included the importance of trusting physician advice, the need for family support, and the lack of nurse involvement, indicating that oncology nurses should improve their support and communication to enhance the decision-making process for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The experience of using decisional support aids by patients with breast cancer. Lacey, MD.[2016]

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 systematic review identified 9 studies that successfully implemented patient-reported outcomes (PROs) to assess adverse events (AEs) in breast cancer treatment, highlighting the feasibility of using these reports in clinical practice.

Three significant AEs—hot flushes, vaginal dryness, and weight gain—were found to be underreported by healthcare providers, indicating a gap in communication that could be addressed through better use of PROs to enhance patient-centered care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes (PRO) focused on adverse events (PRO-AEs) in adjuvant and metastatic breast cancer: clinical and translational implications. Stefanovic, S., Wallwiener, M., Karic, U., et al.[2018]

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]

In a study of 380 patients with metastatic breast cancer undergoing first-line chemotherapy, certain adverse events (AEs) like grade 1 nausea and oral mucositis significantly decreased health utility and quality of life, as measured by the EQ-5D-3L and EORTC QLQ-C30 scales.

Specific AEs, including fatigue and sensory neuropathy, were linked to lower global health status and functioning, highlighting the importance of managing these side effects to improve patient quality of life during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Adverse Events on Health Utility and Health-Related Quality of Life in Patients Receiving First-Line Chemotherapy for Metastatic Breast Cancer: Results from the SELECT BC Study. Hagiwara, Y., Shiroiwa, T., Shimozuma, K., et al.[2019]

A study identified 38 key facts and 27 goals related to three breast cancer treatment decisions (surgery, reconstruction, and adjuvant therapy), based on surveys from an average of 17 patients and 21 providers, ensuring the information was accurate and complete.

While patients and providers agreed on the importance of facts and goals for surgery and reconstruction, there was a notable disagreement regarding chemotherapy and hormone therapy, highlighting the need for decision-making tools that incorporate both perspectives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of instruments to measure the quality of breast cancer treatment decisions. Lee, CN., Dominik, R., Levin, CA., et al.[2022]

A new tool for clinicians in inpatient oncology units has been developed to prevent adverse events and enhance patient safety, focusing specifically on cancer patients.

The tool includes a catalog of adverse events and a risk map, which helps healthcare providers implement best practices in their daily activities to improve clinical safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient safety in the inpatient setting through risk assessment and mitigation. Reche Navarro, MN.[2016]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7072392/

Clinical Decision Support Systems in Breast Cancer The incorporation of digital tools, such as CDSSs, using clinical outcome data can support the treatment decision process for breast cancer.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8669108/

A scoping review of interactive and personalized web ... There are 21 web-based interactive decision tools for guiding breast cancer treatment decisions in current clinical practice.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1386505624003101

A clinical decision support system for breast cancer treatment CureMate is a clinical decision support system to assist in the selection of the first treatment step in breast cancer.

4. nature.com nature.com/articles/s41598-025-06784-2

Development of a clinical decision support system for ... The DDSM dataset produced Specificity, Accuracy, and Sensitivity values of 98.87%, 97.17%, as well as 98.02% for Ensemble Model 1. The ...

5. breast-cancer-research.biomedcentral.com breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-024-01891-w

Impact of an online decision support tool for ductal carcinoma ... Data were collected from January 2019 to April 2022. Users' median estimated risk of dying from DCIS in 10 years decreased from 9% pre-tool to 3 ...

6. esmed.org esmed.org/MRA/mra/article/view/6814

A Clinical Decision Support Tool to Predict Contralateral ... Conclusions. Our developed tool immediately provides individualized contralateral breast cancer risk estimates and could be extremely helpful ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6296071/

Pilot study of decision support tools on breast cancer ... In this paper, we report results of a pilot study conducted to examine the efficacy of two decision support tools, the RealRisks decision aid ( ...