Shared Decision-making and Colorectal Cancer Screening

January 9, 2026 updated by: Tamara J. Cadet, PhD, LICSW, MPH, Abramson Cancer Center at Penn Medicine

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Tamara Cadet, PhD, LICSW, MPH
  • Phone Number: 215-898-5501
  • Email: cadet@upenn.edu

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

75 years to 85 years (Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CRC DA
Stratifying by sex, 30 participants will be randomized to receive the CRC DA pamphlet.
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
Other: Home Safety Pamphlet
Stratifying by sex, 30 will be randomized to receive the home safety information at the visit.
Other: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in CRC Screening Intentions
Time Frame: Baseline, pre-intervention to immediately after the intervention
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Knowledge
Time Frame: Baseline, pre-intervention to immediately after the intervention
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
Perceptions of Shared Decision-making Role
Time Frame: immediately after the intervention
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
Perceptions of the Length of the Decision Aid
Time Frame: immediately after the intervention
Number of participants who indicate the decision aid is the right length, from a likert-scale question
immediately after the intervention
Perceptions of the Clarity of the Decision Aid
Time Frame: immediately after the intervention
Number of participants who indicate the decision aid is clear in the information presented, from a likert-scale question
immediately after the intervention
Perceptions of the Balance of the Decision Aid
Time Frame: immediately after the intervention
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
Feelings of anxiety when reading the decision aid
Time Frame: immediately after the intervention
Number of participants who felt anxious after reading the decision aid, from a likert-scale question
immediately after the intervention
Feelings of usefulness of the decision aid
Time Frame: immediately after the intervention
Number of participants who indicate recommending the decision aid to a friend, from a likert-scale question
immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abramson Cancer Center at Penn Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 18, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UPCC 11223
  • 850357 (Other Identifier: University of Pennsylvania Institutional Review Board)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make individual participant data available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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