Clinical trial · Interventional
Shared Decision-making and Colorectal Cancer Screening
Shared Decision-making and Colorectal Cancer Screening Behaviors Among Older Adults With Low Health Literacy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CRC decision aid pamphlet | Other | — | UNRESOLVED |
| Home Safety Pamphlet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CRC DA
- description
- Stratifying by sex, 30 participants will be randomized to receive the CRC DA pamphlet.
- interventionNames
- Other: CRC decision aid pamphlet
- type
- OTHER
- label
- Home Safety Pamphlet
- description
- Stratifying by sex, 30 will be randomized to receive the home safety information at the visit.
- interventionNames
- Other: Home Safety Pamphlet
Primary outcomes (1)
- measure
- Change in CRC Screening Intentions
- timeFrame
- Baseline, pre-intervention to immediately after the intervention
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 75 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available