Colorectal CancerNCT04748380
Shared Decision-making and Colorectal Cancer Screening
A study testing CRC decision aid pamphlet and Home Safety Pamphlet in people with Colorectal Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 75 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- CRC decision aid pamphlet and Home Safety Pamphlet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- CRC decision aid pamphlet, Home Safety Pamphlet
- Keywords
- decision aid, screening, older adults, low health literacy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRC decision aid pamphletOther
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 PamphletOther
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
| Study group | Role | What they receive |
|---|---|---|
| CRC DA | Experimental | Stratifying by sex, 30 participants will be randomized to receive the CRC DA pamphlet. Receives: 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. Receives: Other: Home Safety Pamphlet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, pre-intervention to immediately after the intervention
Secondary outcomes (7)
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
Measured: Baseline, pre-intervention to immediately after the intervention
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
Measured: immediately after the intervention
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
Measured: immediately after the intervention
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
Measured: immediately after the intervention
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
Measured: immediately after the intervention
Feelings of anxiety when reading the decision aid
Number of participants who felt anxious after reading the decision aid, from a likert-scale question
Measured: immediately after the intervention
Feelings of usefulness of the decision aid
Number of participants who indicate recommending the decision aid to a friend, from a likert-scale question
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start18 Jan 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamara J. Cadet, PhD, LICSW, MPH, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748380
- Sponsor's protocol ID
- UPCC 11223
- Other IDs
- 850357
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2021
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision-making and Colorectal Cancer Screening Behaviors Among Older Adults With Low Health Literacy
- ClinicalTrials.gov ID
- NCT04748380
- Acronym / sponsor ID
- UPCC 11223
- Conditions
- Colorectal Cancer
- Keywords
- decision aid, screening, older adults, low health literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| CRC DA | Experimental | Other: CRC decision aid pamphletStratifying by sex, 30 participants will be randomized to receive the CRC DA pamphlet. |
| Home Safety Pamphlet | Other | Other: Home Safety PamphletStratifying by sex, 30 will be randomized to receive the home safety information at the visit. |
Who may qualify
- Ages
- 75 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRC decision aid pamphletA 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 | CRC DA |
| Home Safety PamphletThe 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 | Other | Home Safety Pamphlet |
Primary outcome
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
7 secondary outcomes
Change in Knowledge
Time frame: Baseline, pre-intervention to immediately after the intervention
Perceptions of Shared Decision-making Role
Time frame: immediately after the intervention
Perceptions of the Length of the Decision Aid
Time frame: immediately after the intervention
Perceptions of the Clarity of the Decision Aid
Time frame: immediately after the intervention
Perceptions of the Balance of the Decision Aid
Time frame: immediately after the intervention
Feelings of anxiety when reading the decision aid
Time frame: immediately after the intervention
Feelings of usefulness of the decision aid
Time frame: immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRC decision aid pamphlet and Home Safety Pamphlet in people with Colorectal Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CRC Screening Intentions (time frame: Baseline, pre-intervention to immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.