Decision Aid Tool for Colorectal Cancer Screening

Overseen By Tamara Cadet, PhD, LICSW, MPH

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Dementia, Colorectal cancer history, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment CRC decision aid pamphlet, Home Safety Pamphlet for colorectal cancer screening?

Research shows that decision aids, like pamphlets, can help people make informed choices about colorectal cancer screening by increasing their knowledge and participation rates. These aids have been shown to improve decision-making processes and screening uptake, especially when they are self-administered or include interactive elements. ^{1 2 3 4 5}

Is the Decision Aid Tool for Colorectal Cancer Screening safe for humans?

The research does not provide specific safety data for the Decision Aid Tool for Colorectal Cancer Screening, but decision aids are generally considered safe as they are educational tools designed to help patients make informed health decisions. ^{6 7 8 9 10}

How is the Decision Aid Tool for Colorectal Cancer Screening different from other treatments?

The Decision Aid Tool for Colorectal Cancer Screening is unique because it helps patients choose their preferred screening option by providing educational information and addressing cultural barriers, rather than being a medical treatment itself. It focuses on improving decision-making and increasing screening intentions, especially among specific groups like American Indian adults. ^{2 6 9 10 11}

Eligibility Criteria

This trial is for adults aged 75-85 with low health literacy, who feel somewhat to not at all confident filling out medical forms. They should have a community college education or less and no history of colorectal cancer, dementia, or lack the capacity to participate.

Inclusion Criteria

Have an educational level at community college or less

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

I am between 75 and 85 years old.

Exclusion Criteria

I am over 85 years old.

I am unable to participate in the trial due to my condition.

You have dementia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either the CRC decision aid pamphlet or the home safety pamphlet during a visit with their primary care physician

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in CRC screening intentions and knowledge, with a chart review and follow-up call at 6 months

6 months

1 follow-up call

Treatment Details

Interventions

• CRC decision aid pamphlet
• Home Safety Pamphlet

Trial Overview The study tests if a new decision aid pamphlet helps these older adults decide about colorectal cancer screening. It looks at their intention to get screened based on life expectancy and risk factors, knowledge increase, engagement in shared decision-making (SDM), and acceptance of the aid.

Participant Groups

Group I: Home Safety Pamphlet Experimental Treatment 1 Intervention

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

Group II: CRC DA Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Simmons University

Lead Sponsor

Trials

1

Recruited

60+

Findings from Research

Patients who received a decision aid from their family physician had a higher fecal occult blood test (FOBT) completion rate (66.6%) compared to those who did not receive the aid (56.9%), indicating that physician recommendations significantly boost screening rates.

The study found that the use of the decision aid itself was low (only 1.1% of patients utilized it), suggesting that direct encouragement from physicians is a more effective strategy for increasing colorectal cancer screening, especially for patients aged 50-59.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does access to a colorectal cancer screening website and/or a nurse-managed telephone help line provided to patients by their family physician increase fecal occult blood test uptake?: results from a pragmatic cluster randomized controlled trial. Clouston, K., Katz, A., Martens, PJ., et al.[2021]

In a pilot study involving 62 adults aged 48-75, the number of colorectal cancer screening options presented in decision aids did not significantly affect overall interest in screening, regardless of whether participants viewed a 5-option or a 2-option version.

While participants who viewed the 2-option decision aid showed a trend towards preferring colonoscopy over the 5-option group when no costs were considered, this preference disappeared when out-of-pocket costs were introduced, indicating that cost may play a crucial role in decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of offering different numbers of colorectal cancer screening test options in a decision aid: a pilot randomized trial. Griffith, JM., Lewis, CL., Brenner, AR., et al.[2021]

The study aims to evaluate how effective self-administered decision aids are for individuals invited to participate in colorectal cancer screening, focusing on their impact on informed choice and knowledge.

Key outcomes will include measuring decisional conflict and actual participation rates in screening, which will help determine if these aids improve engagement in preventive health measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of self-administered decision aids for people invited to participate in colorectal cancer screening: a systematic review protocol. Larsen, MB., Gabel, P., Andersen, B.[2019]

A randomized controlled trial involving 570 participants aged 50-75 years found that both interactive and non-interactive decision aids (DAs) significantly increased colorectal cancer screening (CRCS) rates compared to usual care, which had a much lower rate of 18.6%.

Despite the interactive DA being designed to enhance patient engagement, it did not lead to a higher CRCS rate than the non-interactive DA, indicating that the added complexity of interactivity may not be worth the resources required.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactivity in a Decision Aid: Findings From a Decision Aid to Technologically Enhance Shared Decision Making RCT. Jimbo, M., Sen, A., Plegue, MA., et al.[2020]

A web-based decision aid significantly increased colorectal cancer screening uptake by 8 percentage points among non-participants, indicating its effectiveness in encouraging screening.

While the decision aid did not improve knowledge or attitudes towards screening, it successfully reduced decisional conflict, suggesting it helps individuals feel more confident in their choice to participate in screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a decision aid for colorectal cancer screening on components of informed choice according to educational attainment: A randomised controlled trial. Gabel, P., Larsen, MB., Edwards, A., et al.[2021]

Implementing a centralized delivery system for colorectal cancer (CRC) decision aids (DAs) was feasible, with over 90% of participants recalling receiving the DA and 80% finding it helpful for decision-making.

Despite the increase in CRC screening knowledge due to the DA, overall screening rates actually decreased from 50.8% to 39.2%, indicating that while DAs can enhance understanding, their effectiveness in increasing actual screening rates may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation and Evaluation of a Novel Colorectal Cancer Decision Aid Using a Centralized Delivery Strategy. Tate, CE., Matlock, DD., Dalton, AF., et al.[2019]

The combination of a colorectal cancer (CRC) screening decision aid and patient navigation significantly increased screening completion rates among vulnerable populations, with 68% of participants completing screening compared to only 27% in the usual care group.

This intervention was particularly effective for women, who showed a 50 percentage point increase in screening rates, highlighting the potential of tailored approaches to improve health outcomes in underserved communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Combined Patient Decision Aid and Patient Navigation vs Usual Care for Colorectal Cancer Screening in a Vulnerable Patient Population: A Randomized Clinical Trial. Reuland, DS., Brenner, AT., Hoffman, R., et al.[2022]

Most web-based patient education materials on colorectal cancer screening are written at a reading level above the recommended sixth-grade level, making them difficult for many patients to understand.

The materials often lack important health content, such as addressing specific risks for high-risk groups and common barriers to screening, which could hinder patient engagement and screening rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Readability, suitability, and health content assessment of web-based patient education materials on colorectal cancer screening. Tian, C., Champlin, S., Mackert, M., et al.[2022]

A culturally adapted decision aid significantly improved colorectal cancer (CRC) screening knowledge among 104 American Indian adults, with scores rising from 36% to 76% correct after viewing the aid.

The decision aid also increased participants' positive attitudes, self-efficacy, and intentions towards screening, with the preference for a specific screening modality increasing from 81% to 93%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing a Culturally Adapted Colorectal Cancer Screening Decision Aid Among American Indians: Results from a Pre-Post Trial. Frerichs, L., Beasley, C., Pevia, K., et al.[2021]

A survey of 29 primary care providers indicated that a colorectal cancer screening decision aid improved shared decision making (SDM) by enhancing patient knowledge and helping them choose a preferred screening option.

While most providers found the tool beneficial for decision quality and efficiency, less than half believed it would be easy to implement in practice, highlighting potential barriers to widespread use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provider perspectives on the utility of a colorectal cancer screening decision aid for facilitating shared decision making. Schroy, PC., Mylvaganam, S., Davidson, P.[2021]

Including an explicit discussion of the option not to be screened in a colon cancer screening decision aid led to lower perceived clarity and overall ratings compared to a version that did not include this option, indicating a trade-off in how the information is presented.

Despite differences in subjective measures of clarity and balance, there were no significant changes in participants' interest in screening or their knowledge about colon cancer screening after viewing either version of the decision aid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Should a colon cancer screening decision aid include the option of no testing? A comparative trial of two decision aids. Griffith, JM., Fichter, M., Fowler, FJ., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Does access to a colorectal cancer screening website and/or a nurse-managed telephone help line provided to patients by their family physician increase fecal occult blood test uptake?: results from a pragmatic cluster randomized controlled trial. [2021]

2. England pubmed.ncbi.nlm.nih.gov

The effect of offering different numbers of colorectal cancer screening test options in a decision aid: a pilot randomized trial. [2021]

3. Australia pubmed.ncbi.nlm.nih.gov

Effectiveness of self-administered decision aids for people invited to participate in colorectal cancer screening: a systematic review protocol. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Interactivity in a Decision Aid: Findings From a Decision Aid to Technologically Enhance Shared Decision Making RCT. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of a decision aid for colorectal cancer screening on components of informed choice according to educational attainment: A randomised controlled trial. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Implementation and Evaluation of a Novel Colorectal Cancer Decision Aid Using a Centralized Delivery Strategy. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Effect of Combined Patient Decision Aid and Patient Navigation vs Usual Care for Colorectal Cancer Screening in a Vulnerable Patient Population: A Randomized Clinical Trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Readability, suitability, and health content assessment of web-based patient education materials on colorectal cancer screening. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Testing a Culturally Adapted Colorectal Cancer Screening Decision Aid Among American Indians: Results from a Pre-Post Trial. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Provider perspectives on the utility of a colorectal cancer screening decision aid for facilitating shared decision making. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Should a colon cancer screening decision aid include the option of no testing? A comparative trial of two decision aids. [2021]