Decision Aid Tool for Colorectal Cancer Screening
Recruiting in Palo Alto (17 mi)
Age: 65+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Pennsylvania
Disqualifiers: Dementia, Colorectal cancer history, others
No Placebo Group
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.
12345Is 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.
678910How 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.
2691011Eligibility 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.
+1 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Home Safety PamphletExperimental Treatment1 Intervention
Stratifying by sex, 30 will be randomized to receive the home safety information at the visit.
Group II: CRC DAExperimental Treatment1 Intervention
Stratifying by sex, 30 participants will be randomized to receive the CRC DA pamphlet.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Pennsylvania Health SystemPhiladelphia, PA
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Who Is Running the Clinical Trial?
University of PennsylvaniaLead Sponsor
Abramson Cancer Center at Penn MedicineLead Sponsor
Simmons UniversityLead Sponsor
References
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]Evaluation of the effectiveness of a patient decision aid (nurse-managed telephone support line and/or colorectal cancer screening website), distributed to patients by their family physician, in improving fecal occult blood test (FOBT) colorectal cancer screening rates.
The effect of offering different numbers of colorectal cancer screening test options in a decision aid: a pilot randomized trial. [2021]Decision aids can improve decision making processes, but the amount and type of information that they should attempt to communicate is controversial. We sought to compare, in a pilot randomized trial, two colorectal cancer (CRC) screening decision aids that differed in the number of screening options presented.
Effectiveness of self-administered decision aids for people invited to participate in colorectal cancer screening: a systematic review protocol. [2019]The objective is to assess the effectiveness of self-administered decision aids for people invited to participate in colorectal cancer screening. We will evaluate effects on informed choice, decisional conflict, knowledge, and participation in colorectal cancer screening.
Interactivity in a Decision Aid: Findings From a Decision Aid to Technologically Enhance Shared Decision Making RCT. [2020]Colorectal cancer screening (CRCS) remains underutilized. Decision aids (DAs) can increase patient knowledge, intent, and CRCS rates compared with "usual care," but whether interactivity further increases CRCS rate remains unknown.
Effectiveness of a decision aid for colorectal cancer screening on components of informed choice according to educational attainment: A randomised controlled trial. [2021]The decision to take up colorectal cancer screening has to be made on informed grounds balancing benefits and harms. Self-administered decision aids can support citizens in making an informed choice. A self-administered web-based decision aid targeting citizens with lower educational attainment has been evaluated within the target population. However, the effectiveness in the general screening population remains unexplored. The aim of this study was to evaluate the effectiveness of a web-based decision aid for colorectal cancer screening on components of informed choice among previous non-participants in colorectal cancer screening.
Implementation and Evaluation of a Novel Colorectal Cancer Decision Aid Using a Centralized Delivery Strategy. [2019]Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the United States; however, CRC screening reduces both incidence and mortality rates. Patient decision aids (DAs) are an evidence-based strategy to support patients making health-related decisions. CRC screening DAs can be unsuccessful due to provider preferences for colonoscopy and lack of effective DA implementation strategies within clinical settings.
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]Colorectal cancer (CRC) screening is underused, especially among vulnerable populations. Decision aids and patient navigation are potentially complementary interventions for improving CRC screening rates, but their combined effect on screening completion is unknown.
Readability, suitability, and health content assessment of web-based patient education materials on colorectal cancer screening. [2022]Colorectal cancer (CRC) screening rates in the Unites States are still below target level. Web-based patient education materials are used by patients and providers to provide supplemental information on CRC screening. Low literacy levels and patient perceptions are significant barriers to screening. There are little data on the quality of these online materials from a health literacy standpoint or whether they address patients' perceptions.
Testing a Culturally Adapted Colorectal Cancer Screening Decision Aid Among American Indians: Results from a Pre-Post Trial. [2021]Purpose: American Indian adults have not experienced decreases in colorectal cancer (CRC) incidence and mortality observed in other races or ethnic groups and their screening rates are low. Decision aids that explain available CRC screening options are one potential strategy to promote screening. The goal of this study was to test the effect of a culturally adapted decision aid on CRC-related outcomes among American Indian adults, including screening-related knowledge, attitudes, self-efficacy, intentions, and screening modality preferences. Methods: We recruited American Indian adults aged 50-75 years who were not current with CRC screening. Participants viewed a 9-min multimedia decision aid that used narrative vignettes to provide educational information about screening along with messages to address culturally specific barriers and values uncovered in formative research. We conducted a single-arm (pre-post) study and assessed screening-related outcomes at baseline and immediately after viewing the decision aid. Results: Among n=104 participants, knowledge scores increased from a mean of 36% correct to 76% correct. Participants also had statistically significant increases in positive attitudes, perceived social norms, self-efficacy, and intent. The proportion of participants who identified a preference for a specific CRC screening modality rose from 81% identified at pre-intervention to 93% post-intervention (p=0.013). Conclusion: Our study provides promising new findings that our culturally adapted decision aid is efficacious in educating American Indian adults about CRC screening and increases their screening intentions and ability to state modality preferences. Future research is needed to test the decision aid as a component of CRC screening interventions with American Indian adults.
Provider perspectives on the utility of a colorectal cancer screening decision aid for facilitating shared decision making. [2021]Decision aids for colorectal cancer (CRC) screening have been shown to enable patients to identify a preferred screening option, but the extent to which such tools facilitate shared decision making (SDM) from the perspective of the provider is less well established.
Should a colon cancer screening decision aid include the option of no testing? A comparative trial of two decision aids. [2021]An important question in the development of decision aids about colon cancer (CRC) screening is whether to include an explicit discussion of the option of not being screened. We examined the effect of including or not including an explicit discussion of the option of deciding not to be screened in a CRC screening decision aid on subjective measures of decision aid content; interest in screening; and knowledge.