NCT03865654已完成不适用
Individualizing Surveillance Mammography for Older Breast Cancer Survivors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Rate of Change in Intentions for Mammography in the Next Year
研究概览
简要总结
This research is being conducted to develop consensus on surveillance mammography and follow-up for breast cancer survivors who are age ≥75.
详细描述
The investigators will develop a communication tool that summarizes recommendations for clinicians and patients for surveillance mammography and follow-up care for breast cancer survivors age ≥75. Developing expert-panel recommendations, examining clinician and patient attitudes towards these recommendations, and testing a strategy for communication of expert recommendations on mammography cessation through direct engagement of specialists, primary care clinicians (PCs), and patients.
This is a multi-step study, the investigators will build on prior steps to develop consensus on surveillance mammography and follow-ups for breast cancer survivors who are age >= 75.
This study includes a physician focus group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female gender, given that screening guidelines do not exist for men
- •Receiving part or all of their care at DFCI
- •Ages 75-79 (approximately 15 patients)
- •Age ≥80 (approximately 15 patients)
- •History of stage 0-II breast cancer
- •≥1 Charlson comorbidity present72, defined as one of the following:
- •Liver disease
- •History of or other active malignancy other than non-melanoma skin cancers
- •HIV or AIDS
- •Chronic kidney disease
- •History of myocardial infarction and/or congestive heart failure
- •Chronic lung disease (emphysema/chronic bronchitis/chronic obstructive pulmonary disease [COPD], interstitial lung disease)
- •Peripheral vascular disease
- •Cerebrovascular disease (history of TIA or stroke)
- •Hemiplegia/paralysis
- •Connective tissue disorder
- •Underwent breast conserving surgery for treatment of this cancer
- •Completed all active breast cancer therapy >3 months prior to enrollment (i.e. any chemotherapy, trastuzumab, radiation). Ongoing hormonal therapy or enrollment in survivorship clinical trials (aspirin, exercise, etc) is allowed.
- •English-speaking and reading (for this initial work)
- •Cognitive testing of the communication tool. The criteria for this are intentionally more flexible than in other aims, as we are simply working to initially test the tool and its readability and understandability. Patients will be eligible to cognitively test the tool if they meet the following criteria:
- •Female gender
- •Previous diagnosis of breast cancer
- •Receive some/all care at Dana-Farber Cancer Institute
- •English speaking-reading
- •Pilot testing the communication tool in clinic.
- •Previous diagnosis of stage 0-II breast cancer
- •Receive some/all care at Dana-Farber Cancer Institute (main campus or St. Elizabeth's site)
- •Completed any active breast cancer therapy > 3 months prior to enrollment (i.e. any chemotherapy, trastuzumab, radiation). Ongoing hormonal therapy or enrollment in survivorship clinical trials (aspirin, exercise, etc) is allowed.
- •Had breast-conserving surgery to treat this cancer
- •≥1 the following comorbid conditions72 present, defined as the following:
- •Liver disease
- •History of or other active malignancy other than non-melanoma skin cancers
- •HIV or AIDS
- •Chronic kidney disease
- •History of myocardial infarction and/or congestive heart failure
- •Chronic lung disease (COPD, interstitial lung disease)
- •Peripheral vascular disease
- •Cerebrovascular disease (history of TIA or stroke)
- •Hemiplegia/paralysis
- •Connective tissue disorder
- •Provider does not opt out of the patient's enrollment via email notification
- •Blessed Orientation Memory Concentration (COMC) score is <10 and capacity is met73 (see Appendix A for BOMC scale)
- •Providers of participating patients will be sent a one-time survey but there are no other eligibility for providers to participate in this other than their patient participated
- •English speaking and reading
排除标准
- •Are unable to consent
- •Who do not read and write English (for this initial pilot)
结局指标
主要结局
Rate of Change in Intentions for Mammography in the Next Year
时间窗: 2 years
Survey measure on whether mammography will be done or not
次要结局
- Rate of Satisfaction(2 years)
- Preferred Decision-making Role(2 years)
研究者
Rachel Freedman, MD, MPH
Principal Investigator
Dana-Farber Cancer Institute
研究点 (2)
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