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

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study collects information and identifies decision making needs for older adult women with stage I-III breast cancer considering neoadjuvant and adjuvant chemotherapy. Using this information, a decision support tool is then developed to provide patients and physicians with tailored information regarding the risks and benefits of chemotherapy and values clarification to support high-quality, shared decision. Subsequently, the decision support tool will be tested amongst older patients with early-stage breast cancer and health care providers navigating the decision process around chemotherapy, and further refined through an iterative process.

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.

Is the Decision Support Tool generally safe for humans?

The research articles do not provide specific safety data for the Decision Support Tool itself, but they discuss the importance of monitoring adverse events and improving patient safety in cancer treatment settings. ^{1 2 3 4 5}

How does the Decision Support Tools treatment for breast cancer differ from other treatments?

The Decision Support Tools for breast cancer are unique because they focus on helping patients and doctors make informed decisions about treatment options by providing personalized risk assessments and potential outcomes. Unlike traditional treatments that directly target the cancer, these tools aim to improve decision-making and patient involvement in the treatment process. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Decision Support Tool for breast cancer?

Research shows that decision support tools can help improve the quality of treatment decisions for breast cancer by providing personalized information about risks and benefits, which aids in informed decision-making. These tools have been shown to engage patients in discussions about their treatment options and help them understand the potential impact on survival. ^{6 8 11 12 13}

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

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 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]

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 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]

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 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]

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 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]

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]

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]

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]

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]

Citations

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. Scotland pubmed.ncbi.nlm.nih.gov

The effects of cancer clinical decision support systems on patient-reported outcomes: A systematic review. [2023]

3. France pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Development of instruments to measure the quality of breast cancer treatment decisions. [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. United States pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Traditional Korean medicine treatment for tamoxifen associated adverse events of breast cancer patient: A CARE - Compliant case report. [2021]

8. Canada 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. [2022]

9. Germany 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. [2018]

10. New Zealand 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. [2019]

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

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

12. Netherlands pubmed.ncbi.nlm.nih.gov

Assessing and managing breast cancer risk: clinicians' current practice and future needs. [2022]

13. 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]