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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04748380
• Other study ID #: 19-008
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Abramson Cancer Center at Penn Medicine
• Contact: Tamara Cadet, PhD, LICSW, MPH
• Phone: 215-898-5501
• Email: cadet[@]upenn.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 75 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• CRC decision aid pamphlet
A newly developed 8-10 page decision aid pamphlet that discusses:1. Information on CRC; 2. Information about risk and benefits including the 10-year lag-time to benefitting from CRC screening; 3. Information to help patients evaluate CRC screening options (colonoscopy or stool testing); 4. Possible outcomes relevant to LE and health status. In addition, there will be a values clarification exercise
• Home Safety Pamphlet
The home safety information pamphlet is a 2-page fact sheet on home safety tips for older adults, and was designed by the AGS Health in Aging Foundation. It includes information in seven areas to help older adults stay safe in their homes. Areas include but are not limited to fall prevention and safety proofing homes. It has been used successfully in prior studies of DAs as a control intervention

Locations

Country	Name	City	State
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in CRC Screening Intentions	Number of participants who indicate their intentions to be screened or not be screened for CRC, Change from baseline to immediately after the intervention	Baseline, pre-intervention to immediately after the intervention
Secondary	Change in Knowledge	Number of participants who correctly answer 15 true/false knowledge questions developed the investigators, about the harms and benefits of CRC screening, Change from baseline to immediately after the intervention	Baseline, pre-intervention to immediately after the intervention
Secondary	Perceptions of Shared Decision-making Role	Number of participants who answer the question that participants want to make a CRC screening decision with their physician, from 5 decision-making role questions developed the investigators	immediately after the intervention
Secondary	Perceptions of the Length of the Decision Aid	Number of participants who indicate the decision aid is the right length, from a likert-scale question	immediately after the intervention
Secondary	Perceptions of the Clarity of the Decision Aid	Number of participants who indicate the decision aid is clear in the information presented, from a likert-scale question	immediately after the intervention
Secondary	Perceptions of the Balance of the Decision Aid	Number of participants who indicate the decision aid present information that is not slanted towards CRC screening or slanted away from CRC screening, from a likert-scale question	immediately after the intervention
Secondary	Feelings of anxiety when reading the decision aid	Number of participants who felt anxious after reading the decision aid, from a likert-scale question	immediately after the intervention
Secondary	Feelings of usefulness of the decision aid	Number of participants who indicate recommending the decision aid to a friend, from a likert-scale question	immediately after the intervention