UPCC 11223 Shared Decision-Making and Colorectal Cancer Screening Behaviors Among Older Adults With Low Health Literacy

Investigating Shared Decision-Making and Screening for Colon or Rectal Cancer in Older Adults

Enrolling By Invitation
75 years - 85 years
All
Phase N/A
60 participants needed
1 Location

Brief description of study

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.

Detailed description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Colorectal Cancer
  • Age: 75 years - 85 years
  • Gender: All

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

This study investigates the impact of a decision aid on colorectal cancer screening behaviors among older adults with low health literacy. The purpose of this study is to see if a newly developed decision aid pamphlet can influence the screening intentions of adults aged 75-85, who may have different risk factors and life expectancies.

Participants will be randomly assigned to one of two study arms: one group will receive the colorectal cancer decision aid pamphlet, while the other group will receive a home safety pamphlet. Before their regular doctor visits, participants will answer pretest questions over the phone. After reading their assigned pamphlet, they will have their regular visit with their doctor. A follow-up survey will be conducted after the appointment to assess changes in knowledge and decision-making about colorectal cancer screening.

  • Who can participate: Adults aged 75 to 85 years with low health literacy, as determined by their confidence in filling out medical forms, are eligible. Participants should have an educational level of community college or less. Those with dementia, a history of colorectal cancer, or who are older than 85 years are excluded.
  • Study details: Participants will read either a decision aid or a home safety pamphlet before their doctor visit. They will complete surveys before and after the visit to assess their knowledge and intentions about colorectal cancer screening. A chart review and follow-up call will be conducted at 6 months to evaluate discussions and decisions made regarding screening.
  • Study timelines: The study will last 24 months.
Updated on 12 Jan 2026. Study ID: 21-1453
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