This clinical trial evaluates the effect of a shared-decision aid pamphlet on colorectal cancer (CRC) screening behaviors in older adults with low health literacy (LHL). Health literacy is the degree to which individuals have the capacity to obtain, process and understand health information. Patients older than 75 are at a higher risk for LHL and may lack knowledge of CRC screening options. Decision aids (DA) are educational tools that can provide information on the benefits and harms of a decision, such as CRC screening, and can increase shared decision-making (SDM) between patients and doctors to help patients express their preferences and values. DAs have been shown to increase knowledge, clarify personal values about the benefits and harms of decision options and patient participation in SDM, and decrease conflict surrounding decisions (personal uncertainty about which course of action to take). Providing a CRC DA pamphlet may promote screening in those who are healthy and most likely to benefit while discouraging screening in those who are most likely to be harmed from screening procedures and CRC treatment effects.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04748380.
PRIMARY OBJECTIVES:
I. Identify the information needs and perceptions of LHL older adults about CRC screening.
IIA. Develop a short, paper-based pamphlet CRC DA for use with LHL older adults.
IIB. Modify newly developed CRC DA. 30 cognitively intact LHL adults (50% women), 75-85 years and 10 family members will participate in structured interviews.
III. Conduct a feasibility pilot randomized control trial of my CRC DA including 66 LHL adults 75-85 years recruited from two University of Pennsylvania affiliated hospitals.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive CRC DA pamphlet and review over 5-10 minutes prior to regularly scheduled primary care physician (PCP) visit. Patients also complete a questionnaire pre- and post- PCP. Additionally, patients' medical chart is reviewed at 6 months.
ARM II: Patients receive home safety information and review over 5-10 minutes prior to regularly scheduled PCP visit. Patients also complete a questionnaire pre- and post- PCP visit in person or over the phone. Additionally, patients' medical chart is reviewed at 6 months.
After completion of study intervention, patients are followed up at 6 months.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorTamara Cadet
