Identifying Decision Making Needs for Older Adult Women With Breast Cancer Considering Neoadjuvant or Adjuvant Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Decision making needs assessment questionnaire
研究概览
简要总结
This study collects information and identifies decision making needs for older adult women with stage I-III breast cancer considering neoadjuvant and adjuvant chemotherapy. Using this information, a decision support tool is then developed to provide patients and physicians with tailored information regarding the risks and benefits of chemotherapy and values clarification to support high-quality, shared decision. Subsequently, the decision support tool will be tested amongst older patients with early-stage breast cancer and health care providers navigating the decision process around chemotherapy, and further refined through an iterative process.
详细描述
PRIMARY OBJECTIVES:
I. To characterize and describe the informational needs and preferences in older adult women who intend on receiving neoadjuvant or adjuvant chemotherapy for stage I-III breast cancer.
Ia. Conduct semi-structured interviews with women who have completed the treatment decision process to collect informational needs and elicit decision-making needs and preferences.
Ib. Utilize validated data collection instruments to assess the shared decision-making process and health literacy needs.
II. To develop a decision support tool for use by patients and healthcare providers to guide the chemotherapy decision-making process in older women (>= 65) with early-stage 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
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patient Inclusion Criteria
- •Women aged 65 years or older
- •Must write and speak English
- •Must have been diagnosed with Stage I-III breast cancer
- •Must have made decision to either receive or not receive neoadjuvant or adjuvant chemotherapy
- •Must be within 3 months of breast cancer neoadjuvant or adjuvant chemotherapy treatment decision
- •Self-reported no visual or auditory deficits
- •SUBAIM 2b: Women aged 65 years or older
- •SUBAIM 2b: Must write and speak English
- •SUBAIM 2b: Must have been diagnosed with stage I-III breast cancer
- •SUBAIM 2b: Must be a candidate for chemotherapy or targeted therapy (in the setting of HER2+ breast cancer)
- •SUBAIM 2b: Must be making a decision regarding chemotherapy
- •SUBAIM 2b: Self-reported no visual or auditory deficits
- •PHYSICIAN INCLUSION CRITERIA
- •Physician for patient recruited to participate in study (physician criteria)
排除标准
- 未提供
研究组 & 干预措施
Intervention Arm
Participants in the intervention arm only will then be asked to look at the decision tool that includes educational materials about the diagnosis and treatment of breast cancer.
These could be written information, graphics, videos, animations, or questionnaires.
This decision tool will personalize the decision to you specifically and support your decision-making process
干预措施: Discussion (Other)
Non-Intervention Arm
Participants undergo interviews and complete questionnaires over 1-2 hours. Patients and physicians also participate in a discussion and complete shared decision-making questionnaire over 15-30 minutes.
Intervention Arm
Participants in the intervention arm only will then be asked to look at the decision tool that includes educational materials about the diagnosis and treatment of breast cancer.
These could be written information, graphics, videos, animations, or questionnaires.
This decision tool will personalize the decision to you specifically and support your decision-making process
干预措施: Interview (Other)
Intervention Arm
Participants in the intervention arm only will then be asked to look at the decision tool that includes educational materials about the diagnosis and treatment of breast cancer.
These could be written information, graphics, videos, animations, or questionnaires.
This decision tool will personalize the decision to you specifically and support your decision-making process
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Decision making needs assessment questionnaire
时间窗: through study completion, an average of 1 year
The mean score of the shared decision making questionnaire and its standard deviation along with the median and the range will be computed for both the patient and physician study population. Score Range-(0-4) 0-Not at all confident 4-very confident
次要结局
未报告次要终点