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临床试验/NCT04748380
NCT04748380已完成不适用

Shared Decision-making and Colorectal Cancer Screening Behaviors Among Older Adults With Low Health Literacy

Abramson Cancer Center at Penn Medicine1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年1月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Change in CRC Screening Intentions

研究概览

简要总结

Conduct a feasibility pilot RCT of a newly developed colorectal cancer screening (CRC) decision aid (DA) including 66 LHL adults 76-85 years recruited from community health centers. Hypotheses: Patients in the intervention group will be more likely to change their intentions to be screened with fewer patients with <10 year LE and/or those with >10 year LE and no risk factors intending to be screened and more with >10 year LE and risk factors for CRC and/or those who have never been screened intending to be screened (primary outcome). The secondary outcomes are that the patients in the intervention group will have 1. increased knowledge of CRC screening options and the benefits and risks of these options; 2. increased SDM engagement; and 3. find the DA acceptable. Investigators also anticipate that at least 50% of eligible participants will choose to participate in the study.

详细描述

Investigators will recruit and survey 66 adults (to reach a goal of 60 with complete data), 75-85 years with low health literacy LHL (30 per arm) over 24 months to learn the effects of the newly developed CRC DA pamphlet on older adult's screening intentions, knowledge of options and the benefits and harms, and SDM from community health centers. Investigators collect baseline data over the phone prior to the visit. Patients who are eligible and willing to participate will come to a regularly scheduled visit with their primary care physician (PCP) early to answer the pretest questions. Stratifying by sex, 30 participants will be randomized to receive the CRC DA pamphlet and 30 will be randomized to receive the home safety information at the visit in case they cancel their appointment and reschedule. The home safety information is 2 pages, and was designed by AGS Health in Aging Foundation. It has been used successfully in prior studies of DAs as a control intervention. Investigators chose this pamphlet for the control arm because it is written at <7th grade reading level and reading about home safety should not affect screening decisions. Providing the control group the home safety pamphlet to read reduces response bias since it helps keep participants blinded to the intervention of interest and compensates for the time and attention required by the intervention group to read the DA. At the visit, participants will review the DA or the home safety pamphlet. The revised CRC DA pamphlet is expected to take 5-10 minutes to read as well as the home safety pamphlet. After completing the pre-survey questionnaire before the visit the patient will have their PCP visit. The post-test will be asked after the PCP visit in person or over the phone (depending on the participant's preference, access to a phone, and ability to stay after their appointment for enough time to complete the post-visit questionnaire). Investigators will conduct a chart review at 6 months to see if a CRC screening discussion occurred and the outcome (i.e., qualitative trends in use of CRC screening). Investigators will also call each patient at 6 months to ask about their CRC screening intentions.

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
Single (Participant)

盲法说明

Stratifying by sex, 30 participants will be randomized to receive the CRC DA pamphlet and 30 will be randomized to receive the home safety information at the visit in case they cancel their appointment and reschedule.

入排标准

年龄范围
75 Years 至 85 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Be between the ages of 75 and 85 years
  • Must be low health literacy (LHL), determined by participants' response to the validated LHL question, "How confident are you filling out medical forms by yourself?" with a response of, "somewhat to not at all confident."39-43
  • Have an educational level at community college or less

排除标准

  • Patients who do not have the capacity to participate
  • Patients with dementia
  • Patients with a history of invasive/non-invasive colorectal cancer.
  • Patients older than 85 years since guidelines recommend against CRC screening in this age range.

研究组 & 干预措施

CRC DA

Experimental

Stratifying by sex, 30 participants will be randomized to receive the CRC DA pamphlet.

干预措施: CRC decision aid pamphlet (Other)

Home Safety Pamphlet

Other

Stratifying by sex, 30 will be randomized to receive the home safety information at the visit.

干预措施: Home Safety Pamphlet (Other)

结局指标

主要结局

Change in CRC Screening Intentions

时间窗: Baseline, pre-intervention to immediately after the intervention

Number of participants who indicate their intentions to be screened or not be screened for CRC, Change from baseline to immediately after the intervention

次要结局

  • Perceptions of the Clarity of the Decision Aid(immediately after the intervention)
  • Feelings of usefulness of the decision aid(immediately after the intervention)
  • Perceptions of Shared Decision-making Role(immediately after the intervention)
  • Perceptions of the Length of the Decision Aid(immediately after the intervention)
  • Perceptions of the Balance of the Decision Aid(immediately after the intervention)
  • Change in Knowledge(Baseline, pre-intervention to immediately after the intervention)
  • Feelings of anxiety when reading the decision aid(immediately after the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tamara J. Cadet, PhD, LICSW, MPH

Associate Professor

University of Pennsylvania

研究点 (1)

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