Informational Intervention for Breast Cancer

Overseen By Daniel Hertz

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan Rogel Cancer Center

Must be taking: Taxanes

Disqualifiers: Inability to read or speak English

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

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial studies how well a chemotherapy-induced peripheral neuropathy (CIPN) decision aid works in improving chemotherapy decision making among patients with breast cancer. CIPN involves numbness or tingling in the hands or feet and is a debilitating side effect of several commonly used classes of cancer drugs. CIPN symptoms are typically minor at first but can progress with continued treatment to severe symptoms that can affect long-term function, falls risk, and quality of life. Symptoms sometimes resolve after treatment but in patients who experienced CIPN, symptoms are still present 1 year post-treatment in about two-thirds of patients and 3 years post-treatment in approximately half of the patients. Previous studies indicate patients lack awareness of long-term CIPN symptoms. A decision aid that provides information about permanent CIPN, that helps patients understand their treatment priorities, and prepares them for a discussion with their medical oncologist may lead to improvements in treatment decision making, satisfaction with decision making, and ultimately increase patient's achievement of their treatment goals.

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 is best to discuss this with your medical oncologist.

What data supports the effectiveness of the CIPN Decision Aid treatment for breast cancer?

Research shows that decision aids help patients participate more in decision making and make better-informed choices about their treatment. In a study, patients using a decision aid for breast cancer prevention had improved knowledge and were more consistent in their treatment preferences over time. ^{1 2 3 4 5}

Is the Informational Intervention for Breast Cancer safe for humans?

The research articles reviewed focus on decision aids for breast cancer treatment choices, but they do not provide specific safety data for the Informational Intervention for Breast Cancer or CIPN Decision Aid. These studies primarily assess decision-making processes and patient satisfaction rather than safety outcomes. ^{3 6 7 8 9}

How is the CIPN Decision Aid treatment for breast cancer different from other treatments?

The CIPN Decision Aid is unique because it focuses on helping patients make informed decisions about their breast cancer treatment options, rather than being a direct medical treatment itself. It aims to improve patient knowledge and satisfaction by providing clear information and facilitating shared decision-making, which can lead to better decision-related outcomes. ^{2 5 7 10 11}

Research Team

Daniel L Hertz

Principal Investigator

University of Michigan Rogel Cancer Center

Eligibility Criteria

This trial is for breast cancer patients who are about to decide on their chemotherapy treatment. It aims to help those who might be at risk of developing CIPN, a condition causing numbness or tingling in the hands and feet due to certain cancer drugs.

Inclusion Criteria

Approval of medical oncologist to enroll patient

I am currently on my third cycle of taxane treatment.

I have breast cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Supportive Care

Participants receive the CIPN DecisionAid to improve chemotherapy decision making

12 weeks

Follow-up

Participants are monitored for changes in awareness, discussion confidence, decision empowerment, and satisfaction

4 weeks

Treatment Details

Interventions

• CIPN Decision Aid

Trial Overview The study tests a decision aid designed to inform patients about the risks of long-term CIPN from chemotherapy. The goal is to improve satisfaction with treatment decisions and align them more closely with patient priorities.

Participant Groups

Group I: Supportive care (CIPN DecisionAid) Experimental Treatment 2 Interventions

Patients receive the CIPN DecisionAid on study.

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials

303

Recruited

20,700+

Findings from Research

The implementation of patient decision aids (PtDAs) for early stage breast cancer treatment is feasible in community settings, with nine out of twelve sites successfully using them with patients.

Key factors for successful implementation included the enthusiasm of nurses and social workers in distributing the PtDAs, while barriers included lack of physician support and organized distribution systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing breast cancer decision aids in community sites: barriers and resources. Silvia, KA., Ozanne, EM., Sepucha, KR.[2021]

The distribution of decision aids (DAs) to 1098 breast cancer patients significantly increased their knowledge and reduced decisional conflict, indicating that these tools are effective in supporting patient decision-making.

Patients with lower baseline knowledge, higher decisional conflict, and those of Hispanic ethnicity showed the most significant improvements, suggesting that targeted use of DAs could further enhance their effectiveness for specific groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of decision aids in a sustained implementation at a breast care center. Belkora, JK., Volz, S., Teng, AE., et al.[2022]

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 shared decision-making aid for breast cancer prevention was found to be feasible and acceptable during consultations, with no significant difference in consultation duration between the intervention and control groups (24 minutes vs. 21 minutes).

Participants using the decision aid showed a significant improvement in breast cancer prevention knowledge immediately after the consultation (p = 0.01), but this knowledge returned to baseline levels at follow-up, indicating a need for ongoing support in decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot trial of a computerized decision aid for breast cancer prevention. Ozanne, EM., Annis, C., Adduci, K., et al.[2007]

In a study involving 282 high-risk women aged 35 to 75, the use of a web-based decision aid alongside standard educational materials did not significantly increase the uptake of breast cancer chemoprevention at 6 months, with rates remaining low at 2.1% for the intervention group and 3.5% for the control group.

Despite the lack of increased uptake, the decision support tools improved participants' understanding of breast cancer risk and chemoprevention knowledge, indicating that while uptake was low, the tools were effective in enhancing informed decision-making about breast cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and Provider Web-Based Decision Support for Breast Cancer Chemoprevention: A Randomized Controlled Trial. Crew, KD., Bhatkhande, G., Silverman, T., et al.[2023]

The study evaluated decision aids designed for low-socioeconomic status (SES) women with early-stage breast cancer, finding that the Picture Option Grid was the most acceptable and feasible tool for improving patient understanding and involvement in treatment decisions.

Using visual displays and plain language in decision aids significantly helped patients of both low and high SES comprehend statistical information, but the Comic Option Grid was less favored, indicating a need for further research on these tools in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the acceptability and feasibility of encounter decision aids for early stage breast cancer targeted at underserved patients. Alam, S., Elwyn, G., Percac-Lima, S., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Implementing breast cancer decision aids in community sites: barriers and resources. [2021]

2. Ireland pubmed.ncbi.nlm.nih.gov

Impact of decision aids in a sustained implementation at a breast care center. [2022]

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

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

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

Pilot trial of a computerized decision aid for breast cancer prevention. [2007]

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

Decision aids and breast cancer: do they influence choice for surgery and knowledge of treatment options? [2022]

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

Reducing Decisional Conflict and Enhancing Satisfaction with Information among Women Considering Breast Reconstruction following Mastectomy: Results from the BRECONDA Randomized Controlled Trial. [2022]

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

Information needs and decision-making preferences of older women offered a choice between surgery and primary endocrine therapy for early breast cancer. [2022]

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

Patient and Provider Web-Based Decision Support for Breast Cancer Chemoprevention: A Randomized Controlled Trial. [2023]

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

A bedside decision instrument to elicit a patient's preference concerning adjuvant chemotherapy for breast cancer. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Assessing the acceptability and feasibility of encounter decision aids for early stage breast cancer targeted at underserved patients. [2018]

11. Netherlands pubmed.ncbi.nlm.nih.gov

A systematic review of decision aids for patients making a decision about treatment for early breast cancer. [2022]