Shared Decision-making and Colorectal Cancer Screening

NCT04748380 | Completed

• 2 other identifiers: UPCC 11223850357
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

decision aid; screening; older adults; low health literacy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in Knowledge

  Baseline, pre-intervention to immediately after the intervention

• Perceptions of Shared Decision-making Role

  immediately after the intervention

• Perceptions of the Length of the Decision Aid

  immediately after the intervention

• Perceptions of the Clarity of the Decision Aid

  immediately after the intervention

• Perceptions of the Balance of the Decision Aid

  immediately after the intervention

Study Arms (2)

CRC DA

EXPERIMENTAL

Stratifying by sex, 30 participants will be randomized to receive the CRC DA pamphlet.

Other: CRC decision aid pamphlet

Home Safety Pamphlet

OTHER

Stratifying by sex, 30 will be randomized to receive the home safety information at the visit.

Other: Home Safety Pamphlet

Interventions

CRC decision aid pamphlet OTHER

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

CRC DA

Home Safety Pamphlet OTHER

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

Home Safety Pamphlet

Eligibility Criteria

• Age: 75 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: February 10, 2021
• Study Start: January 18, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)