Clinical trial · Interventional
Colorectal Cancer Awareness, Research, Education and Screening (CARES)
NCT01804179CI-TRIAL-00060766completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
There are two parts to this study: (1) an information gathering phase leading to the development of new educational materials; and (2) a study to test the newly developed material. The information gathering phase has been completed. The purpose of this part of the research study is to test the usefulness and acceptability of new educational materials investigators have developed. Investigators will compare the new educational material to another widely available educational brochure. The goal is to see if the new educational material will change knowledge and behaviors about colorectal cancer and colorectal screening.
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Baseline Visit Survey | Other | — | UNRESOLVED |
| CARES Intervention Educational Materials | Other | — | UNRESOLVED |
| Follow-up Questionnaire | Other | — | UNRESOLVED |
| Immunochemical Fecal Occult Blood Test (I-FOBT) Kit | Other | — | UNRESOLVED |
| Standard Intervention (SI) Educational Materials | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard Intervention (SI)
- description
- At Baseline Visit, Participants in the standard intervention (SI) condition will get: I-FOBT kit and "Screen for Life" brochure, a mailed reminder card at two weeks post-intervention to remind them about FOBT testing and follow up assessments at 12 months.
- interventionNames
- Other: Immunochemical Fecal Occult Blood Test (I-FOBT) Kit
- Other: Standard Intervention (SI) Educational Materials
- Other: Baseline Visit Survey
- Other: Follow-up Questionnaire
- type
- EXPERIMENTAL
- label
- CARES Intervention
- description
- Colorectal Cancer Awareness, Research, Education and Screening (CARES). At Baseline Visit, Participants in the CARES intervention will receive: I-FOBT kit, a newly developed DVD and booklet, and a mailed reminder card at two weeks post-intervention to remind them about FOBT testing, and follow-up assessments at 12 months.
- interventionNames
- Other: Immunochemical Fecal Occult Blood Test (I-FOBT) Kit
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Racially-ethnically diverse adult men and women * Average risk individuals who have no personal diagnosis, or presumptive symptoms of colorectal cancer (CRC), or are not at high risk * Self-report as not current on screening * Provide at least two forms of contact information and contact information of a relative (not living with respondent) to facilitate follow-up contacts * Are able to speak, read and write English because the instruments and CARES intervention are available only in English at this time. We recognize that interventions are needed for non-English speaking populations, therefore, once we find promise in the English language CARES intervention materials, we will move forward with conducting other studies that involve translation of measures and cultural adaptation of the CARES intervention materials into Spanish or Haitian Creole. Exclusion Criteria: * Individuals who have participated in a CRCS research study in the past 1 year will not be eligible for this study. * Recent screening criteria relates to not having had I-FOBT within the previous year, flex sig within the previous 5 years, a double-contrast barium enema (DCBE) x-ray with the previous 5 years, or a colonoscopy within the previous 10 years. * Within the recruitment and intervention frame, high risk individuals (due to strong family history, ulcerative colitis, polyposis syndromes) are excluded because they may be eligible for CRC screening before age 50, and the preferred screening option is certainly colonoscopy which is beyond the primary focus of the current study.
References
Publications (0)
Data not yet available
No reference posted for this study.