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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the CIPN Decision Aid can assist breast cancer patients in making informed decisions about their chemotherapy treatment. The tool addresses chemotherapy-induced peripheral neuropathy (CIPN), a common side effect causing numbness or tingling in the hands and feet. The aim is to enhance patients' understanding and discussions with their doctors, leading to improved satisfaction and outcomes. Suitable candidates include those with breast cancer currently on their third cycle of taxane chemotherapy and experiencing any level of CIPN symptoms. Access to a smartphone or similar device is necessary to use the Decision Aid. As an unphased trial, this study provides a unique opportunity to contribute to research that could improve decision-making tools 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 is best to discuss this with your medical oncologist.

What prior data suggests that this decision aid is safe for improving chemotherapy decision making?

Research has shown that a decision aid for chemotherapy-induced peripheral neuropathy (CIPN) can assist patients with breast cancer in making better treatment choices. However, specific safety information for the CIPN Decision Aid itself is not available. This tool provides details about CIPN, a side effect of some cancer drugs that causes numbness or tingling in the hands and feet. The decision aid helps patients understand their treatment options and prepares them to discuss these with their doctors.

As the decision aid is neither a medication nor a medical procedure, it lacks the physical risks associated with medical treatments. Instead, it serves as an informational tool to support decision-making. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CIPN Decision Aid because it's a unique approach for managing chemotherapy-induced peripheral neuropathy (CIPN) in breast cancer patients. Unlike traditional treatments that focus solely on medication, this intervention provides patients with an informational tool to help them make informed decisions about managing their symptoms. This empowerment through education can lead to personalized care strategies, potentially improving quality of life and treatment adherence.

What evidence suggests that this decision aid is effective for improving chemotherapy decision making in breast cancer patients?

Research has shown that a decision aid can help breast cancer patients make better treatment choices, particularly concerning a side effect called chemotherapy-induced peripheral neuropathy (CIPN). CIPN can cause numbness or tingling in the hands or feet due to chemotherapy, and many patients are unaware of this side effect, which can sometimes be permanent. In this trial, participants will receive the CIPN Decision Aid, which provides information about CIPN and helps patients understand what is important to them in their treatment. Better decision-making can lead to greater satisfaction and help patients achieve their treatment goals. Studies highlight the importance of knowing about these long-term side effects for making informed decisions. ^{1 2 5 6 7}

Who Is on the Research Team?

Daniel L Hertz

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/GO.24.00160

Predictive Factors of Chemotherapy-Induced Peripheral ... Baseline CRP, NLR, BMI level, and marital status are significant predictors of CIPN occurrence throughout chemotherapy.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06915168

Study Details | NCT06915168 | CIPN Decision Aid for the ... This clinical trial studies how well a chemotherapy-induced peripheral neuropathy (CIPN) decision aid works in improving chemotherapy decision making among ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12086117/

Tolerance for chemotherapy-induced peripheral ... Women with mBC favored longer duration of progression-free survival, less severe CIPN in hands and feet, and shorter CIPN duration.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2468294225000097

Effects of compression therapy combined with exercise on ... Compression therapy and EXCAP can effectively reduce the incidence of chemotherapy-induced peripheral neuropathy in patients undergoing breast cancer ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2822154

Patient-Reported Outcome Measures for Evaluating Nerve ... Peripheral nerve damage following cancer treatment is common, affecting up to 90% of patients exposed to neurotoxic chemotherapies including ...

6. ascopubs.org ascopubs.org/doi/full/10.1200/OA-25-00136

Effect of Chemotherapy-Induced Peripheral Neuropathy ... These data will be critical to build decision aids or other shared decision making tools that inform patients of their risk of persistent CIPN ...

7. withpower.com withpower.com/trial/phase-breast-neoplasms-10-2024-0e80c

Informational Intervention for Breast Cancer The research articles reviewed focus on decision aids for breast cancer treatment choices, but they do not provide specific safety data for the Informational ...