Individualizing Approaches to Surveillance Mammography in Older Breast Cancer Survivors - The I-MAMMO Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 364
- 试验地点
- 1
- 主要终点
- Mammography Rate
研究概览
简要总结
This study evaluates the effectiveness of a Shared Decision-Making (SDM) toolkit designed to support older breast cancer survivors aged 80 and above in making informed decisions about continuing surveillance mammography.
详细描述
This study evaluates the effectiveness of a Shared Decision-Making (SDM) toolkit designed to support older breast cancer survivors aged 80 and above in making informed decisions about continuing surveillance mammography.
A participant will be placed into one of two groups: Group A: Usual Care vs. Group B: SDM Toolkit according to the randomized placement of the assigned study clinician.
Study procedures include questionnaires and option interviews with study staff.
Participation in this research study is expected to last about 2 years.
It is expected about 52 clinicians and 312 participants will take part in this research study.
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
盲法说明
randomized to having educational material or not.
入排标准
- 年龄范围
- 80 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participant Inclusion Criteria:
- •Women aged ≥ 80 years at the time of registration
- •History of stage 0-III breast cancer (Of note: ductal carcinoma in situ [DCIS], pleomorphic lobular carcinoma in situ [because it is typically treated like DCIS], or invasive breast cancer of any subtype are all eligible)
- •No history of a recurrent breast cancer (i.e., a breast cancer that is deemed metastatic or a locoregional recurrence of a prior cancer per clinician judgement rather than a new primary breast cancer). If a person has been diagnosed with multiple distinct breast cancers over time (e.g., history of left and right breast cancer), they are eligible as long as they meet other requirements for time since surgery, etc.
- •Has at least one intact breast
- •Has had mammogram screening/surveillance within the last 24 months
- •≥ 12 months since most recent breast surgery to affected breast (e.g., breast reduction surgery on an unaffected breast within 12 months is ok)
- •No active cancer-directed therapy other than hormonal therapy and/or CDK 4/6 inhibitor therapy
- •Ability and willingness to take surveys
- •Receiving at least some of their oncology follow-up care at a participating site
- •Most recent mammogram report for the potential participant did not recommend additional diagnostic work-up or close interval follow-up imaging
- •If a patient required diagnostic breast testing in the past or at the time of the most recent mammogram AND the results were resolved to benign findings with no additional diagnostics recommended, they are eligible.
- •If a patient's most recent mammogram result isn't yet available at the time of approach or study consent, the patient is eligible to proceed with consent and enrollment. If this mammogram then abnormal or requires additional imaging, that patient will not be included in the study analyses or surveys. This patient will be replaced.
- •Participant
排除标准
- •Inability to provide informed consent
- •Assigned male sex at birth
- •Breast or recent imaging findings requiring diagnostic testing at baseline
- •Prior discontinuation of mammography by electronic medical record (EMR) review or patient report
- •Prior atypical ductal hyperplasia (ADH) or non-pleomorphic LCIS only
- •Psychiatric illness situations that would limit compliance with study requirements
- •Those with metastatic breast cancer
- •Those in hospice care
- •Those whose clinician is not willing to participate
- •Pregnant women, young patients, and those in prison will not be eligible for enrollment given the study design and aims supporting study in a different population focused on older adults
- •Clinician Inclusion Criteria:
- •Must be an active clinician (MD, NP, or PA) at a participating institution
- •Sees at least one breast-cancer survivor aged ≥ 80
- •Clinician must be able to read, speak, and write in English
研究组 & 干预措施
Shared-Decision Making Toolkit
Enrolled participants will complete:
- Year 1 standard of care visit with clinician followed by post-visit survey
- Optional semi-structured interview with study staff
- Year 2 standard of care visit with clinician followed by post-visit survey
- Optional semi-structured interview with study staff
- End of study survey
干预措施: Shared Decision-Making Toolkit (Behavioral)
Usual Care
Enrolled participants will continue with standard care practices without the SDM toolkit and will complete:
- Year 1 standard of care visit with clinician followed by post-visit survey
- Year 2 standard of care visit with clinician followed by post-visit survey
- Optional semi-structured interview with study staff
结局指标
主要结局
Mammography Rate
时间窗: Assessed at 2 years post-enrollment.
Mammography Rate is defined as the proportion of participants that undergo mammography by 2 years post-enrollment.
次要结局
- Mammography Count(Assessed at 2 years post-enrollment.)
- Participant Decisional Quality Score(Annually through 2 years of follow-up post-enrollment.)
- Participant Knowledge Score(Annually through 2 years of follow-up post-enrollment.)
研究者
Rachel Freedman, MD, MPH
Principal Investigator
Dana-Farber Cancer Institute