Decisions About Cancer Screening in Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 442
- 试验地点
- 10
- 主要终点
- Decisional Conflict Scale
研究概览
简要总结
The Decisions about Cancer screening in Alzheimer's Disease (DECAD) study tests if an evidence-based decision aid for dementia caregivers can support decision-making about mammography and improve the quality of medical decision-making about breast cancer screening. This large randomized controlled trial will recruit up to 450 dyads (900 individual participants) of older women with dementia and a family caregiver, for a goal of 426 dyad baselines (852 individual participants).
详细描述
Alzheimer's disease and related dementias (ADRD) impact a woman's life expectancy and her ability to participate in medical decision-making about breast cancer screening, necessitating the involvement of family caregivers. Making decisions about mammography screening for women with ADRD is stressful. There are no data that suggest that breast cancer screening helps women with ADRD live longer or better. Decision aids may improve the quality of decision-making about mammography for ADRD patients and may inform family caregivers about the risks, benefits, and need for decision-making around mammography screening.
The Decisions about Cancer Screening in Alzheimer's Disease (DECAD) trial, a randomized controlled clinical trial, will enroll 426 dyads of older women with ADRD (≥75 years) and a family caregiver from clinics and primary-care practices to test a novel, evidence-based decision aid. This decision aid includes information about the impact of ADRD on life expectancy, the benefit of mammograms, and the impact on the quality of life for older women with ADRD. Dyads will be randomized to receive the decision aid or active control information about home safety. This trial will examine the effect on the caregiver's decisional conflict (primary outcome) and the caregiver's decision-making self-efficacy (secondary outcome). A second follow-up at 15 months will include a brief, semi-structured interview with the caregiver regarding the patient's experience with mammograms and decision-making about mammograms. At the same time, a review of the patient's electronic medical record (EMR) will look at discussions about mammography with their primary-care physician and mammogram orders, receipt, results, and burden (e.g., additional diagnostic procedures due to false-positive results, identification of an abnormality on the screening exam but further work-up declined, and identification of a clinically unimportant cancer).
We hypothesize that caregivers who receive the decision aid will have lower levels of decisional conflict and higher levels of decision-making self-efficacy compared to the control group. We also hypothesize that the DECAD decision aid will reduce mammography use among older women with ADRD.
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
- 75 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female and 75 years or older
- •At least one mammogram in the past five years
- •Primary care visit scheduled in the next 12 months
- •Diagnosis of Alzheimer's disease or related dementia as determined by ICD-10 code
- •Ability to provide informed consent or assent
- •Ability to communicate in English
排除标准
- •Permanent resident of a nursing facility
- •Had a mammogram in the past 6 months
- •Primary care visit scheduled is the first visit with the PCP
- •Made a decision to stop getting mammograms
- •History of Atypical Ductal Hyperplasia, lobular carcinoma in situ, ductal carcinoma in situ, or non-invasive breast cancer
- •Has mild cognitive impairment, serious mental illness such as bipolar or schizophrenia as determined by ICD-10 code
- •Caregiver Inclusion Criteria:
- •18 years or older
- •Primary family caregiver of the patient*
- •Must have a telephone
- •Ability to provide informed consent
- •Ability to communicate in English
- •Caregiver Exclusion Criteria:
- •Caregiver is a non-family member who is not a legal Healthcare Power of Attorney
- •Less than a 7th grade education**
- •Made a decision that the patient will stop getting mammograms
- •Has a diagnosis of AD or has a serious mental illness such as bipolar or schizophrenia as determined by ICD-10 code
结局指标
主要结局
Decisional Conflict Scale
时间窗: Change in DCS score from Baseline to post-PCP Index Visit. Post-PCP Index visit routinely occurs 0-5 days after the patient's index visit with their PCP.
The Decisional Conflict Scale (DCS) includes 16-items on a 1-5 Likert scale. Questions are regarding a medical decision that participants have made or that they are about to make; it measures uncertainty around a decision, whether one feels informed, clear about their personal values, and supported in their decision-making It is a validated and widely accepted measure of decision quality that has been used in previous studies of decision aids intended for AD caregivers. Scores can range from 0-100, with lower scores indicating less conflict. This survey is completed during the baseline and Post-Index PCP visit.
次要结局
- Change in Decision-making Self-efficacy Scale Score(Change in Decision Self-Efficacy score from Baseline to post-PCP Index Visit. Post-PCP Index visit routinely occurs 0-5 days after the patient's index visit with their PCP.)
- Caregiver Role in Decision Making(The above values represent the number of caregivers that completed the assessment at post-PCP Index Visit. Post-PCP Index visit routinely occurs 0-5 days after the patient's index visit with their PCP.)
- Receipt of Mammogram Screening(15 month post intervention)
- Change in Caregiver Knowledge About Mammograms in Older Women With ADRD(Change in Caregiver knowledge from Baseline to post-PCP Index Visit. Post-PCP Index visit routinely occurs 0-5 days after the patient's index visit with their PCP.)
- Caregiver Intention for the Patient to Receive Mammogram Screening in the Future(Post-PCP Index visit routinely occurs 0-5 days after the patient's index visit with their PCP.)
研究者
Nicole R. Fowler, PhD
Associate Professor of Medicine
Indiana University