Decision Aid for Breast Cancer

Not currently recruiting at 104 trial locations

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: SWOG Cancer Research Network

Must not be taking: SERMs, AIs, Hormone therapy

Disqualifiers: Invasive breast cancer, Breast implants, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of web-based tools in helping patients and healthcare providers make informed decisions about breast cancer prevention. It focuses on women with atypical hyperplasia (a non-cancerous condition with abnormal cells) or lobular carcinoma in situ (a marker that increases breast cancer risk). Participants will receive educational materials, and some will use decision support tools, known as the Decision Aid, to better understand their breast cancer risk and prevention options. The trial seeks women diagnosed with these conditions who have not used certain breast cancer prevention drugs. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance decision-making tools for breast cancer prevention.

Will I have to stop taking my current medications?

If you are currently taking selective estrogen receptor modulators (SERMs) or aromatase inhibitors (AIs), you will need to stop, as the trial excludes participants with prior or current use of these medications. Additionally, you cannot be on hormone replacement therapy.

What prior data suggests that these decision support tools are safe for use in breast cancer chemoprevention?

Research has shown that decision aids for breast cancer are safe and easy to use. These tools help patients make informed choices about preventing breast cancer. Studies have found that decision aids do not cause harm or side effects, as they provide information rather than medical treatment. Therefore, participants in trials using decision aids can trust in their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way of helping patients make decisions about breast cancer prevention. Unlike traditional methods that mainly provide educational materials, this approach offers personalized decision support. It uses RealRisks to give patients a detailed action plan based on their unique risk profiles and preferences, helping them understand the pros and cons of using SERMs or AIs for chemoprevention. This patient-centered approach aims to empower individuals and enhance their decision-making process, potentially leading to more informed and personalized preventive care choices.

What evidence suggests that this decision aid is effective for improving informed choice about breast cancer chemoprevention?

This trial will compare two approaches to using decision aids for breast cancer prevention. Research has shown that decision aids help women make better choices about preventing breast cancer. Past studies have demonstrated that these tools improve understanding of prevention options, aiding women at high risk in weighing the pros and cons. However, while decision aids increase knowledge and assist with decision-making, they do not always result in more women choosing prevention treatments. The main goal is to help patients make choices that align with their personal preferences and health goals. This evidence supports the idea that decision aids can enhance informed decision-making in breast cancer prevention. ^{1 3 6 7 8}

Who Is on the Research Team?

Katherine D Crew

Principal Investigator

SWOG Cancer Research Network

Are You a Good Fit for This Trial?

This trial is for English or Spanish-speaking women aged 35-74 with atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS), who have internet access and can give informed consent. It's not for those pregnant, lactating, with a history of invasive breast cancer or ductal carcinoma in situ, prior/current use of certain breast cancer drugs, hormone therapy, bilateral mastectomies/breast implants, or premenopausal thromboembolism.

Inclusion Criteria

Recruitment Centers must be willing to allow the S1904 study team access to the site's application program interface (API) for integration of the study materials (standard educational materials and decision support tools) into the EHR and patient portal. (NOTE: Both Group 1 (control) and Group 2 (intervention) recruitment centers may access the standard educational materials via the patient portal or uniform resource locator (URL)/website)

Patients must be able to access the internet and receive email or text messages. This is required to access study materials and receive email/text message reminders from the S1904 Study Team at Columbia University Irving Medical Center (CUIMC). The patient decision aid, RealRisks, is accessible via smartphones, tablets, or personal computers. If patients do not own these devices, local study personnel will provide resources for patients to access RealRisks via computer kiosks or tablets in clinic waiting rooms or public locations, such as community centers or public libraries

As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

Exclusion Criteria

I have never had invasive breast cancer or ductal carcinoma in situ.

I am not currently on hormone replacement therapy.

I have not had both breasts removed or have breast implants.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of web-based decision support tools for patients and healthcare providers to improve informed choice about breast cancer chemoprevention

6 months

1 visit (in-person) at 6 months

Follow-up

Participants are monitored for safety and effectiveness after intervention, with assessments at multiple time points

Up to 5 years

Follow-up visits at 6, 12, 24, 36, 48, and 60 months

What Are the Treatments Tested in This Trial?

Interventions

• Decision Aid

Trial Overview

The MiCHOICE study tests web-based decision support tools to help patients and healthcare providers make informed choices about breast cancer chemoprevention. The goal is to understand how these tools affect decision-making processes and their integration into clinical practice.

How Is the Trial Designed?

Group I: Group II (educational materials, decision support, interview) Experimental Treatment 4 Interventions

Patients receive standard educational materials about breast cancer risk and chemoprevention in RealRisks via the patient portal or website. Patients receive patient-centered decision support within the patient portal via an action plan summarizing their breast cancer risk profile, their risks and benefits of SERMs and AIs, and personal preferences for chemoprevention. Health care providers receive decision support and action plans based on their patients' interactions with RealRisks via the BNAV provider-centered support tool within the EHR. A sample of patients participate in an audio-recorded interview via telephone or video conference over 45-60 minutes at 12 months after registration. A sample of health care providers participate in 3 audio-recorded interviews via telephone or video conference over 45-60 minutes each at baseline, within 12-36 months after study activation, and within 12 months after study closure to accrual.

Group II: Group I (educational materials) Active Control 2 Interventions

Patients receive standard educational materials about breast cancer risk and chemoprevention in RealRisks via the patient portal or website.

Who Is Running the Clinical Trial?

SWOG Cancer Research Network

Lead Sponsor

Trials

403

Recruited

267,000+

Southwest Oncology Group

Lead Sponsor

Trials

389

Recruited

260,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The breast cancer prevention decision aid significantly improved knowledge and created more realistic expectations about breast cancer risk among 27 women aged 50-69 at higher risk, indicating its effectiveness as an educational tool.

When used alongside counselling, the decision aid notably reduced decisional conflict and psychological distress, while also increasing intentions to adopt healthier lifestyle practices, suggesting it enhances the decision-making process for women at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and evaluation of a breast cancer prevention decision aid for higher-risk women. Stacey, D., O'Connor, AM., DeGrasse, C., et al.[2022]

In a study involving 632 women at increased risk for breast cancer, a tailored decision aid significantly improved knowledge about tamoxifen, with 63% answering most questions correctly.

Despite increased understanding, only 6% of participants expressed a willingness to take tamoxifen for chemoprevention, largely due to concerns that the risks outweighed the benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Women's decisions regarding tamoxifen for breast cancer prevention: responses to a tailored decision aid. Fagerlin, A., Zikmund-Fisher, BJ., Nair, V., et al.[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]

Breast cancer patients (BCPs) expressed a strong preference for information on how side effects impact their daily lives, prioritizing quality of life themes like energy levels, arm function, and pain over just the risks of side effects.

A significant majority (89%) of BCPs also wanted individualized risk information about side effects, indicating that the BRASA patient decision aid (BRASA-PtDA) should be redesigned to focus on quality of life impacts first, while still providing personalized risk details.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer patients' most important quality of life themes for a radiotherapy decision aid. Roumen, C., Hasannejadasl, H., Swart, R., et al.[2022]

An online decision aid significantly increased the number of women making informed choices about breast cancer chemoprevention, with 52.7% of participants in the intervention group making informed decisions compared to only 5.9% in the standard control group immediately after the intervention.

However, the positive impact of the decision aid on informed decision-making diminished over time, as seen in the three-month follow-up where only 16.9% of the intervention group maintained informed choices, compared to 11.8% and 8.0% in the control groups, indicating a need for ongoing education and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informed choice about breast cancer prevention: randomized controlled trial of an online decision aid intervention. Korfage, IJ., Fuhrel-Forbis, A., Ubel, PA., 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]

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]

A patient decision aid (PtDA) was developed for older women with Stage I, estrogen receptor-positive breast cancer, which helped them understand the benefits and risks of adjuvant radiotherapy after lumpectomy, leading to improved treatment-related knowledge.

After using the PtDA, participants reported a significant reduction in decisional conflict and increased clarity regarding their treatment options, suggesting that the PtDA effectively supports informed decision-making in this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of patients' decision aid for older women with stage I breast cancer considering radiotherapy after lumpectomy. Wong, J., D'Alimonte, L., Angus, J., et al.[2019]

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]

Decision aids significantly reduced treatment decision conflicts for breast cancer patients compared to conventional methods, indicating they can help patients feel more confident in their treatment choices.

However, decision aids did not significantly impact screening decision conflicts or other factors like anxiety, decision regret, and satisfaction, suggesting their effectiveness may be limited to specific decision-making scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluate the effectiveness of breast cancer decision aids: A systematic review and meta-analysis of randomize clinical trails. Gao, JP., Jin, YH., Yu, SF., et al.[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]

Citations

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pmc.ncbi.nlm.nih.gov

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Development and evaluation of a breast cancer prevention ...

Objective To develop and evaluate the effectiveness of a breast cancer prevention decision aid for women aged 50 and older at higher risk of breast cancer.

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breast-cancer-research.biomedcentral.com/articles/10.1186/bcr3479

Decision aids for breast cancer chemoprevention

Decision aids have the potential to improve knowledge and decision-making in this context, but they do not guarantee increased uptake of chemoprevention.

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/24004815/

Informed choice about breast cancer prevention - PubMed - NIH

We aimed to examine the impact of an online breast cancer chemoprevention decision aid (DA) on informed intentions and decisions of women at high risk of breast ...

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ascpjournal.biomedcentral.com/articles/10.1186/s13722-024-00534-x

Rationale and design of a randomized clinical trial of ...

In a two parallel-arm randomized controlled trial, we are assessing an innovative eHealth delivery model that integrates PrEP with MOUD and is tailored to meet ...

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researchgate.net

researchgate.net/publication/388142345_Rationale_and_design_of_a_randomized_clinical_trial_of_integrated_eHealth_for_PrEP_and_medications_for_opioid_use_disorders_for_women_in_the_criminal_legal_system_The_Athena_study

(PDF) Rationale and design of a randomized clinical trial ...

Participants will be randomized to (a) the “Athena strategy,” which includes a PrEP decision aid and integrated PrEP/MOUD delivery via eHealth; or (b) enhanced ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3978421/

Decision aids for breast cancer chemoprevention - PMC

The article by Korfage and colleagues in this issue of Breast Cancer Research investigates the efficacy of an online decision aid for improving ...

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eprognosis.ucsf.edu

eprognosis.ucsf.edu/decision_aids.php

ePrognosis Decision Aids

This decision aid is designed to help women age 55 and older decide how often to undergo mammography screening and when to stop screening.

8.

breast-cancer-research.biomedcentral.com

breast-cancer-research.biomedcentral.com/articles/10.1186/bcr3468

randomized controlled trial of an online decision aid intervention

The 'Guide to Decide' DA provided tailored information (see section 2.3 for details) to women at increased risk of breast cancer about the risks ...