Decision Support Tools for Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Meghan Karuturi

Age: 65+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: M.D. Anderson Cancer Center

Stay on Your Current Meds

No Placebo Group

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 3 11 12 13}

Research Team

Meghan Karuturi

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Decision Support Tool (Behavioural Intervention)

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.

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

M D Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3107

Patients Recruited

1,813,000+

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 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]

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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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. 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]