Decision Aid for Breast Cancer

Recruiting at 98 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

412 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies the implementation of web-based decision support tools for patients with atypical hyperplasia or lobular carcinoma in situ and healthcare providers. Decision support tools are designed to improve informed choice about breast cancer chemoprevention. Recognizing barriers and facilitators that can influence the adoption of decision support tools at recruitment centers may help researchers learn how to best implement them into clinical practice.

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 data supports the effectiveness of the treatment Decision Aid for Breast Cancer?

Research shows that decision aids can help women with breast cancer make informed choices by improving their knowledge and reducing decisional conflict. In a study, women using a decision aid had better understanding of breast cancer prevention and maintained their decision preferences over time compared to those who did not use the aid. ^{1 2 3 4 5}

Is the Decision Aid for Breast Cancer safe for humans?

The research articles do not provide specific safety data for the Decision Aid for Breast Cancer, but they focus on its use in helping women make informed decisions about breast cancer prevention and treatment options. ^{2 5 6 7 8}

How does the decision aid for breast cancer differ from other treatments?

The decision aid for breast cancer is unique because it helps women at higher risk of breast cancer make informed choices about prevention and treatment options, such as whether to use chemopreventive drugs like tamoxifen and raloxifene, which can reduce the risk of developing breast cancer by 50%. This tool focuses on enhancing understanding and decision-making rather than directly treating the condition. ^{1 7 9 10 11}

Research Team

Katherine D Crew

Principal Investigator

SWOG Cancer Research Network

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

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

3. 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]

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

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

6. Netherlands pubmed.ncbi.nlm.nih.gov

Women's decisions regarding tamoxifen for breast cancer prevention: responses to a tailored decision aid. [2022]

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

Informed choice about breast cancer prevention: randomized controlled trial of an online decision aid intervention. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Breast cancer patients' most important quality of life themes for a radiotherapy decision aid. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Development and evaluation of a breast cancer prevention decision aid for higher-risk women. [2022]

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

Evaluate the effectiveness of breast cancer decision aids: A systematic review and meta-analysis of randomize clinical trails. [2021]

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

Development of patients' decision aid for older women with stage I breast cancer considering radiotherapy after lumpectomy. [2019]