An Intervention to Improve Decision Role Concordance Amongst Newly Diagnosed Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Decision role concordance before and after a surgical consultation
研究概览
简要总结
The goal of this project is to test the effects of the Patient Preference Scale as the basis for a clinical intervention for role negotiation in breast cancer surgery decisions and the Patient Perception Scale to measure role concordance. The investigators hypothesize that better role concordance will be achieved with a simple provider-based intervention. In the first half of the study, providers will be blind to the patient's preferred role. In the second half, providers will be made aware of the preferred role prior to the encounter and will have a brief conversation with the patient about their desired role in the decision making process.
详细描述
The goal of this project is to test the effects of the Patient Preference Scale as the basis for a clinical intervention for role negotiation in breast cancer surgery decisions and the Patient Perception Scale to measure role concordance. The investigators hypothesize that better role concordance will be achieved with a simple provider-based intervention. In addition, role concordance will be associated with improved short-term and longer-term improvements in outcomes of the following parameters: a) satisfaction with decision process b) breast specific QOL, and c) decision regret.
The investigators propose a mixed methods, interventional study with concurrent controls performed in a breast cancer surgery clinic at a comprehensive cancer center. The Patient Preference Scale will be used to identify the preferred involvement in decision making of newly diagnosed breast cancer patients prior to their first clinic visit. The Patient Perception Scale will be used after the encounter in order to evaluate role concordance. The Provider Perception Scale will also be used to assess the perception of the achieved role by the provider. In the first half of the study, providers will be blind to the patient's preferred role. In the second half, providers will be made aware of the preferred role prior to the encounter and will have a brief conversation with the patient about their desired role in the decision making process. Clinical encounters will be audiotaped, transcribed, and scored for patient involvement. The investigators propose the following aims and hypotheses:
Investigate the impact of a brief provider-led intervention about the patients' preferred role in treatment decision making on role concordance. The investigators hypothesize that:
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Role concordance will be improved when the preferred role is discussed with the patient at the beginning of the encounter.
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The provider's perception of the role achieved will be more concordant with the patient's perception when the preferred role is discussed. 3. Investigate the impact of role concordance in the treatment decision making process on short term and long term quality of life and decision outcomes. The investigators hypothesize that: Patients who achieve role concordance will be more satisfied with the decision process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients who present to Huntsman Cancer Hospital/University of Utah for a newly diagnosed breast cancer surgical consultation.
排除标准
- •Men with breast cancer.
- •Patients who have previously seen another medical provider to discuss treatment for newly diagnosed breast cancer.
研究组 & 干预措施
The non-intervention control group
In the non-intervention control group, providers are blind to the patient's preferred decision making role.
The intervention group
The provider will be informed of the patient preference in treatment decision making (preferred role) and have a discussion about this with the patient in the intervention group.
干预措施: Patient Preference in Treatment Decision Making (Behavioral)
结局指标
主要结局
Decision role concordance before and after a surgical consultation
时间窗: The estimated period is 3 hours (before and immediately after a surgical consultation)
The primary outcome measures the changes from patient's preferred role in baseline (before a surgical consultation) to the perception of whether the patient achieved the preferred role (immediately after a surgical consultation) in the surgical consultation.
Decision role concordance of provider and patient
时间窗: This is an one-time measurement (Immediately after a surgical consultation)
It measures the difference in the patient's perception of the achieved role and provider's perception of the patient's preferred role.
次要结局
- completion or intention to complete therapies(6 months after initial clinic visit)
- Patient's satisfaction with the decision making process(immediately after a surgical consultation)
- Comparing Reliability and Validity of the Functional Assessment of Cancer Therapy-Breast (FACT-B) assessment of short-term quality of life between the groups(This scale will be used prior to the first consultation to establish a baseline for each patient and will subsequently be used at 2 weeks and 6 months after initial clinic visit.)
- The Decision Regret outcome(The scale will be administered at 2 weeks and 6 months after initial clinic visit.)
- Observing Patient Involvement in Decision Making (OPTION) assessment of patient involvement(4 months after initial clinic visit)
研究者
Cindy Matsen
Principal Investigator
University of Utah