NCT02823262终止不适用
A Breast Cancer Treatment Decision Aid for Women Aged 70 and Older
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 65
- 试验地点
- 4
- 主要终点
- Change in Decisional Conflict Scale at 1 week
研究概览
简要总结
The purpose of this research study is to evaluate a decision aid to help women aged 70 and older decide on treatment for their breast cancer.
详细描述
The investigators aim to use this information to further refine and evaluate a decision aid to help newly-diagnosed women aged 70 and older with breast cancer understand the risks and benefits of different types of breast cancer treatment. The Decision Aid (DA) was created for women 70 years or older diagnosed with ER+, HER2-, clinically LN-, 3cm or less breast cancers deciding on breast cancer treatment. The DA was designed considering the health literary, cognitive abilities, treatment outcomes, and competing health issues of older women.
Phase I :
- The investigators will obtain and incorporate additional feedback on the DA from women 70 years or older who were diagnosed with breast cancer > 6 months ago, their family members, and clinicians, so that the DA can be refined and evaluated by women who were recently treated for breast cancer but not newly diagnosed with breast cancer.
Phase II
- The investigators plan to test the efficacy of the revised DA in a randomized control trial (RCT) of 230 diverse women 70 years or older newly diagnosed with ER+, LN-, HER2-, 3 cm or less breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient age ≥ 70 yrs
- •Female patient diagnosed with a first primary ER+, HER2-, LN-, 3cm or less breast cancer >6 months ago but <2 years ago
- •Caregiver age >21 years
- •English speaking
- •Female patient age ≥ 70 yrs newly diagnosed with a first primary ER+, HER2-, LN-, 3cm or less breast cancer
- •Women newly diagnosed with breast cancer on the day of surgical consult
排除标准
- •Patient Age < 70 years
- •Women diagnosed with Paget's disease, inflammatory breast cancer or a phyllodes tumor
- •Signs of Dementia
- •Score >10 on the Orientation-Memory-Concentration (OMC) test
- •Non-English Speaking;
- •Caregiver age < 21 years
- •Women who do not have capacity to participate. --- Before enrolling women in this study, possible participants will be asked 7 questions about the benefits and risks of the study. Women that answer 3 or more of these questions incorrectly will be excluded.
- •Women with a history of breast cancer (invasive and non-invasive)
- •Diagnosed with Paget's disease, inflammatory breast cancer or a phyllodes tumor
- •Signs of Dementia
- •Score >10 on the OMC test (indicative of dementia).
- •Women who do not have capacity to participate. --- Before enrolling women in this study, possible participants will be asked 7 questions about the benefits and risks of the study. Women that answer 3 or more of these questions incorrectly will be excluded.
结局指标
主要结局
Change in Decisional Conflict Scale at 1 week
时间窗: Baseline, 1 week
Scores on the decisional conflict scale (DCS, range from 0 \[none\] to 100 \[extremely high decisional conflict\]
次要结局
- Self-Efficacy using 11-item scale(One week)
- Values using importance scale 1-10(One week)
- Desired role in decision-making using one-item tool(One week)
- Decision Regret using one-item tool(5 months)
- Anxiety using 6-item Spielberger State-Trait Anxiety Inventory short-form(One week, 5 months)
- Acceptability using 0-3 scale(1 week)
- Change in Stage of Decision-Making at one week using one-item tool(Baseline, One week)
- Treatment preferences using two-item tool(One week)
- Preparation for Decision-Making using 10 items (1-5 scale(One week, 5 months)
- Knowledge score using our knowledge test(One week, 5 Months)
- Quality of Life using the SF-12 physical and mental component scores(One week, 5 months)
- Actual role in decision-making using one-item tool(5 months)
- Satisfaction with treatment decision using 4-item tool(5 months)
- Satisfaction with the decision process using 4-item tool(5 months)
- Treatment received using chart abstraction(5 months)
研究者
Mara Schonberg
Mara Schonberg, MD, MPH
Beth Israel Deaconess Medical Center
研究点 (4)
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