Shared Decision-making and Colorectal Cancer Screening

Colorectal Cancer Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

• NCT number: NCT04748380
• Study type: Interventional
• Source: Abramson Cancer Center at Penn Medicine
• Contact: Tamara Cadet, PhD, LICSW, MPH
• Phone: 215-898-5501
• Email: cadet@upenn.edu
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2023
• Completion date: December 31, 2024