Clinical trial NCT04748380: Shared Decision-making and Colorectal Cancer Screening
Official title: Shared Decision-making and Colorectal Cancer Screening Behaviors Among Older Adults with Low Health Literacy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Keywords: decision aid
screening
older adults
low health literacy
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 60
Sex: ALL
Minimum age (years): 75
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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 criteria: 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.

Primary outcomes:
measure: Change in CRC Screening Intentions
timeFrame: Baseline, pre-intervention to immediately after the intervention
Secondary outcomes:
measure: Change in Knowledge
timeFrame: Baseline, pre-intervention to immediately after the intervention
measure: Perceptions of Shared Decision-making Role
timeFrame: immediately after the intervention
measure: Perceptions of the Length of the Decision Aid
timeFrame: immediately after the intervention
measure: Perceptions of the Clarity of the Decision Aid
timeFrame: immediately after the intervention
measure: Perceptions of the Balance of the Decision Aid
timeFrame: immediately after the intervention
measure: Feelings of anxiety when reading the decision aid
timeFrame: immediately after the intervention
measure: Feelings of usefulness of the decision aid
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
Study officials:
References: