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- Ensaio Clínico NCT07899151
Decision Support for Chemoprevention
Integrating Breast Cancer and Cardiovascular Disease Risk to Explore Decision-Making for Chemoprevention Among Women at High Risk for Breast Cancer
The purpose of this study is to find out whether electronic tools that provide information and reminders to people at high risk for breast cancer and their healthcare providers can increase the use of medications, such as tamoxifen, that may help lower the risk of developing breast cancer. The study will also look at how these tools can be successfully used as part of routine medical care.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This randomized controlled trial will evaluate whether the web-based RealRisks decision aid, combined with standard educational materials, increases breast cancer chemoprevention uptake among women at high risk for breast cancer compared with standard educational materials alone. The intervention incorporates individualized breast cancer and cardiovascular disease risk information to support informed decision-making regarding chemoprevention. The primary endpoint is chemoprevention uptake at 12 months. Secondary outcomes include medication beliefs, breast cancer risk perceptions, informed choice, and decision conflict.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Research Nurse Navigator
- Número de telefone: 212-342-5162
- E-mail: cancerclinicaltrials@cumc.columbia.edu
Estude backup de contato
- Nome: Rita Kukafka, DrPH, MA
- Número de telefone: 212-305-1945
- E-mail: rk326@cumc.columbia.edu
Locais de estudo
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New York
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New York, New York, Estados Unidos, 10032
- Recrutamento
- Columbia University Irving Medical Center
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Contato:
- Research Nurse Navigator
- E-mail: cancerclinicaltrials@cumc.columbia.edu
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Contato:
- Número de telefone: 212-342-5162
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
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Women, age 40-79 years (ages which overlap for the BCSC and ASCVD risk calculators)
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High-risk for breast cancer based upon any of the following criteria:
- Histologically-confirmed atypical hyperplasia or lobular carcinoma in situ
- At least a 3% breast cancer risk at 5 years or 5% risk at 10 years or 20% lifetime risk according to one of the following breast cancer risk models: Breast Cancer Surveillance Consortium risk calculator V3 (https://tools.bcsc-scc.ucdavis.edu/BC5yearRisk/#calculator), Gail Breast Cancer Risk Assessment Tool (https://bcrisktool.cancer.gov/calculator.html), Tyrer-Cuzick model V8 (https://ibis-risk-calculator.magview.com), or BOADICEA canrisk model (https://www.canrisk.org)
- Known carriers of germline pathogenic/likely pathogenic variant in the following breast cancer predisposition genes (ATM, BRCA2, CHEK2, or PALB2)
- Prior chest wall irradiation before age 30 years
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English- or Spanish-speaking
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Has a clinician affiliated with NYP/CUIMC
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Able to provide written, verbal or online informed consent
Exclusion Criteria:
- Patients who have a prior history of invasive breast cancer or ductal carcinoma in situ are ineligible to participate.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Sem intervenção: Control
Standard educational materials regarding breast cancer chemoprevention. |
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Experimental: Intervention
Standard educational materials plus access to the RealRisks web-based decision aid. RealRisks provides personalized breast cancer and ASCVD risk assessment, educational modules, and individualized action planning. |
Behavioral/Educational Material |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Chemoprevention Uptake
Prazo: 12 months after randomization
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The primary outcome is to compare the uptake of breast cancer chemoprevention with selective estrogen receptor modulators (SERMs) or aromatase inhibitors (AIs) at 12 months among women at high-risk for breast cancer assigned to standard educational materials alone or combined with the web-based decision aid, RealRisks. Assessed by EHR log and self-report |
12 months after randomization
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Beliefs about medication
Prazo: Baseline, 6 months, 12 months
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Beliefs in Medication Questionnaire (BMQ)adapted for use in chemoprevention decision-making. The BMQ includes the Necessity scale (10 items that assess how patients perceive their personal need for chemoprevention for reducing BC risk, maintaining their health, and preventing illness), the Concerns scale (10 items measuring concerns about potential adverse effects of chemoprevention). Participants rate the extent to which they agree with each item on a scale (scored 1- 5). The total score for each scale is computed by adding the scores for each scale item together and dividing by the number of items. |
Baseline, 6 months, 12 months
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Perceived Breast Cancer Risk
Prazo: Baseline, 6 months, and 12 months
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3 items of absolute estimate, comparative risk assessed on a 3-point Likert scale, and numeric 10-year risk of breast cancer on a scale of 0 to 100% |
Baseline, 6 months, and 12 months
|
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Perceived Cardiovascular Disease Risk
Prazo: Baseline, 6-months and 12-months
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3 items of absolute estimate, comparative risk assessed on a 3-point Likert scale, and numeric 10-year risk of cardiovascular disease on a scale of 0 to 100%. |
Baseline, 6-months and 12-months
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Accuracy of Perceived Breast Cancer Risk
Prazo: Baseline, 6 months, and 12 months
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Difference between perceived numeric risk estimate and actual 10-year risk of breast cancer risk according to the BCSC risk calculator; Categorized as accurate if the difference between subjective and objective risk estimates are ≤5% in either direction, underestimate if >5% below objective risk, and overestimate if >5% above objective risk |
Baseline, 6 months, and 12 months
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Accuracy of Perceived Cardiovascular Disease Risk
Prazo: Baseline, 6-month, and 12-month
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Difference between perceived numeric risk estimate and actual 10-year risk of Cardiovascular Disease Risk according to the 2013 ACA/AHA ASCVD risk calculator; Categorized as accurate if the difference between subjective and objective risk estimates are ≤5% in either direction, underestimate if >5% below objective risk, and overestimate if >5% above objective risk |
Baseline, 6-month, and 12-month
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Informed Choice
Prazo: Baseline, 6 months, and 12 months
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This measure combines the chemoprevention knowledge scale, an attitudes scale, and chemoprevention decision. Informed choice defined as 1) those who have an adequate knowledge score, a positive attitude towards chemoprevention, and decide to take chemoprevention; 2) those who have an adequate knowledge score, a negative attitude towards chemoprevention, and decide not to take chemoprevention. |
Baseline, 6 months, and 12 months
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Decision Conflict
Prazo: Baseline, 6 months, and 12 months
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Score on the 10-item Decision Conflict Scale assessing uncertainty and conflict related to decisions about chemoprevention uptake. Items are rated using three response categories: Yes (0), Unsure (2), and No (4). Scores are summed, divided by 10, and multiplied by 25. Final scores range from 0 to 100, with higher scores indicating greater conflict and lower scores indicating less conflict. |
Baseline, 6 months, and 12 months
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Intention or decision about chemoprevention uptake
Prazo: Baseline, 6 months, and 12 months
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Behavioral intentions to take chemoprevention measured using 'Given what you know right now, how likely do you think you are to take a breast cancer prevention drug in the next year?' (1 = 'not at all likely,' to 5 = 'extremely likely'). |
Baseline, 6 months, and 12 months
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Factors influencing intention about chemoprevention
Prazo: Baseline, 6 months, and 12 months
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Survey item to rank the main factors influencing a patient's decision about chemoprevention: 1) Personalized risk information; 2) polypharmacy for CVD or other comorbidities; 3) Provider recommendation; 4) RealRisks DA; 5) Other:____ |
Baseline, 6 months, and 12 months
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Perceived usefulness of RealRisks
Prazo: 6 months and 12 months
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Preparation for Decision Making scale. 10-items assesses a patients perception of how useful a DA or decision support intervention is in preparing the respondent to communicate with their provider at a consultation making a health decision. |
6 months and 12 months
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Acceptability of RealRisks
Prazo: 6 months and 12 months
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Ottawa 10-item Acceptability questionnaire includes questions evaluating comprehensibility, sufficiency of information, and overall suitability of the DA for decision making. |
6 months and 12 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Rita Kukafka, DrPH, MA, Columbia University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- AAAV2148
- 5R01CA293927-03 (Concessão/Contrato do NIH dos EUA)
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