Decision Aid for Breast Cancer
Recruiting in Palo Alto (17 mi)
+93 other locations
Overseen byKatherine D Crew
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: SWOG Cancer Research Network
Must not be taking: SERMs, AIs, Hormone therapy
Disqualifiers: Invasive breast cancer, Breast implants, others
No Placebo Group
Approved in 1 Jurisdiction
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.
12345Is 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.
25678How 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.
1791011Eligibility 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
+19 more
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.
+3 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Group II (educational materials, decision support, interview)Experimental Treatment4 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 Control2 Interventions
Patients receive standard educational materials about breast cancer risk and chemoprevention in RealRisks via the patient portal or website.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Aurora West Allis Medical CenterWest Allis, WI
Queen's Cancer Center - Pearlridge'Aiea, HI
The Cancer Center of Hawaii-Pali Momi'Aiea, HI
Loyola University Medical CenterMaywood, IL
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
SWOG Cancer Research NetworkLead Sponsor
Southwest Oncology GroupLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Impact of decision aids in a sustained implementation at a breast care center. [2022]We examined the reach and impact of five decision aids (DAs) routinely distributed to breast cancer patients as part of a shared decision making demonstration project.
Implementing breast cancer decision aids in community sites: barriers and resources. [2021]To assess the feasibility of implementing four patient decision aids (PtDAs) for early stage breast cancer treatment decisions into routine clinical care in community settings.
Assessing the acceptability and feasibility of encounter decision aids for early stage breast cancer targeted at underserved patients. [2018]Women of low socioeconomic status (SES) diagnosed with early stage breast cancer are less likely to be involved in treatment decisions. They tend to report higher decisional regret and poorer communication. Evidence suggests that well-designed encounter decision aids (DAs) could improve outcomes and potentially reduce healthcare disparities. Our goal was to evaluate the acceptability and feasibility of encounter decision aids (Option Grid, Comic Option Grid, and Picture Option Grid) adapted for a low-SES and low-literacy population.
Pilot trial of a computerized decision aid for breast cancer prevention. [2007]This study sought to evaluate a shared decision-making aid for breast cancer prevention care designed to help women make appropriate prevention decisions by presenting information about risk in context. The decision aid was implemented in a high-risk breast cancer prevention program and pilot-tested in a randomized clinical trial comparing standard consultations to use of the decision aid. Physicians completed training with the decision aid prior to enrollment. Thirty participants enrolled (15 per group) and completed measures of clinical feasibility and effectiveness prior to, immediately after, and at 9 months after their consultations. The decision aid was feasible to use during the consultations as measured by consultation duration, user satisfaction, patient knowledge, and decisional conflict. The mean consultation duration was not significantly different between groups (24 minutes for intervention group versus 21 minutes for control group, p = 0.42). The majority found the decision aid acceptable and useful and would recommend it to others. Both groups showed an improvement in breast cancer prevention knowledge postvisit, which was significant in the intervention group (p = 0.01) but not the control group (p = 0.13). However, the knowledge scores returned to baseline at follow-up in both groups. Decision preference for patients who chose chemoprevention post consultations remained constant at follow-up for the intervention group, but not for the control group. The decision framework provides access to key information during consultations and facilitates the integration of emerging biomarkers in this setting. Initial results suggest that the decision aid is feasible for use in the consultation room. The tendency for the decision choices and knowledge scores to return to baseline at follow-up suggests the need for initial and ongoing prevention decision support.
Patient and Provider Web-Based Decision Support for Breast Cancer Chemoprevention: A Randomized Controlled Trial. [2023]Significant underutilization of breast cancer chemoprevention remains, despite guidelines stating that physicians should recommend chemoprevention with antiestrogen therapy to high-risk women. We randomized women, ages 35 to 75 years, who met high-risk criteria for breast cancer, without a personal history of breast cancer or prior chemoprevention use, to standard educational materials alone or combined with a web-based decision aid. All healthcare providers, including primary care providers and breast specialists, were given access to a web-based decision support tool. The primary endpoint was chemoprevention uptake at 6 months. Secondary outcomes included decision antecedents (perceived breast cancer risk/worry, chemoprevention knowledge, self-efficacy) and decision quality (decision conflict, chemoprevention informed choice) based upon patient surveys administered at baseline, 1 and 6 months after randomization. Among 282 evaluable high-risk women enrolled from November 2016 to March 2020, mean age was 57 years (SD, 9.9) and mean 5-year invasive breast cancer risk was 2.98% (SD, 1.42). There was no significant difference in chemoprevention uptake at 6 months between the intervention and control groups (2.1% vs. 3.5%). Comparing the intervention and control arms at 1 month, there were significant differences among high-risk women in accurate breast cancer risk perceptions (56% vs. 39%, P = 0.017), adequate chemoprevention knowledge (49% vs. 27%, P
Women's decisions regarding tamoxifen for breast cancer prevention: responses to a tailored decision aid. [2022]Tamoxifen reduces primary breast cancer incidence, yet causes serious side effects. To date, few women with increased breast cancer risk have elected to use tamoxifen for chemoprevention. The objective of the study was to determine women's knowledge of and attitudes toward tamoxifen following exposure to a tailored decision aid (DA). A total of 632 women with a 5-year risk of breast cancer > or = 1.66% (Mean = 2.56, range = 1.7-17.3) were recruited from two healthcare organizations. Participants viewed an online DA that informed them about their 5-year risk of breast cancer and presented individually tailored content depicting the risks/benefits of tamoxifen prophylaxis. Outcome measures included behavioral intentions (to seek additional information about tamoxifen, to talk to a physician about tamoxifen, and to take tamoxifen); knowledge; and perceived risks and benefits of tamoxifen. After viewing the DA, 29% of participants said they intended to seek more information or talk to their doctor about tamoxifen, and only 6% believed they would take tamoxifen. Knowledge was considerable, with 63% of women answering at least 5 of 6 knowledge questions correctly. Participants were concerned about the risks of tamoxifen, and many believed that the benefits of tamoxifen did not outweigh the risks. This study is the largest to date to test women's preferences for taking tamoxifen and one of the largest to have tested the impact of a tailored DA. After viewing the DA, women demonstrated good understanding of tamoxifen's risks and benefits, but most were not interested in taking tamoxifen for breast cancer chemoprevention.
Informed choice about breast cancer prevention: randomized controlled trial of an online decision aid intervention. [2022]Tamoxifen and raloxifene are chemopreventive drugs that can reduce women’s relative risk of primary breast cancer by 50%; however, most women eligible for these drugs have chosen not to take them. The reasons for low uptake may be related to women’s knowledge or attitudes towards the drugs. 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 cancer.
Breast cancer patients' most important quality of life themes for a radiotherapy decision aid. [2022]The BRASA patient decision aid (BRASA-PtDA) facilitates shared decision making for breast cancer patients (BCPs) facing a radiotherapy treatment decision. During evaluations, patients indicated the wish for quantitative information on side effects. Therefore, this study assessed BCPs opinion on which and how information on side effects should be incorporated in the BRASA-PtDA.
Development and evaluation of a breast cancer prevention decision aid for higher-risk women. [2022]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.
Evaluate the effectiveness of breast cancer decision aids: A systematic review and meta-analysis of randomize clinical trails. [2021]To assess the effectiveness of decision aids in the treatment, prevention and screening of breast cancer patients.
Development of patients' decision aid for older women with stage I breast cancer considering radiotherapy after lumpectomy. [2019]To develop a patient decision aid (PtDA) for older women with Stage I, pathologically node negative, estrogen receptor-positive progesterone receptor-positive breast cancer who are considering adjuvant radiotherapy after lumpectomy and to examine its impact on patients' decision making.