An interventional study of Decision Support & Navigation and Standard in Colorectal Cancer, sponsored by Thomas Jefferson University. Completed at 3 sites in United States. Open to participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-04.
Sponsored by Thomas Jefferson University · Not applicable, Interventional, and Prevention
This study is designed to test a standard mailed intervention (SI) versus a novel decision support and navigation intervention (DSNI). Working with patients and stakeholders, this randomized trial will include 400 Hispanic men and women who are 50 to 75 years of age, patients in community based primary care practices, and are eligible for CRC screening. We will consent, survey, and randomize participants either to the SI Group (n=200) or the DSNI Group (n=200). Study specific aims are to: (1) Assess intervention (DSNI versus SI) impact on overall CRC screening adherence; (2)Assess intervention (DNSI versus SI) impact on CRC screening decision stage; (3) Assess intervention (DNSI versus SI) impact on test-specific CRC screening adherence; and (4) Assess intervention (DNSI versus SI) impact on CRC and knowledge and perceptions.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 400 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Thomas Jefferson University is the lead sponsor of 384 studies on the registry; 71 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
SI Group participants will be mailed a set of standard materials. The materials will include a letter from the participant's primary care practice encouraging selection and performance of either (1) colonoscopy screening, or (2) stool blood test (SBT) screening. Accompanying the letter will be instructions for arranging a colonoscopy appointment and instructions for completing an enclosed immunochemical SBT kit. Print materials and contacts will be provided, in both English and Spanish, after the baseline survey. At 45 days following random assignment that encourages screening.
Behavioral: Standard
DSNI Group will be mailed print materials, including a letter from the practice on CRC screening, an informational booklet, and instructions for arranging a colonoscopy appointment and for completing an enclosed immunochemical SBT kit. All materials will be provided in both English and Spanish. Within 7 days after this mailing, participants will receive a telephone call from a trained bilingual study navigator. Following the call, the navigator will enter the participant's screening plan into the participant's electronic medical record, send the participant a letter describing the screening plan, and send the participant's primary care provider a copy of that same letter. At 45 days following random assignment, research staff will send participants a reminder letter encouraging the participant's preferred test. At 6 months after randomization, the navigator will send the provider and their office manager a participant CRC screening status report.
Behavioral: Decision Support & Navigation
Overall Screening Adherence
The two study groups will be compared in terms of the fraction of participants who undergo CRC screening (through SBT, colonoscopy, flexible sigmoidoscopy, etc.) within 12 months of the randomization date. Screening will be measured using data from the 6-month survey and the 12-month chart audit.
Time frame: 12 months
Change in Screening Decision Stage
At baseline and endpoint (6-month) survey, participants were asked about their decision stage regarding CRC screening. Possible decision stages are, ranked from lowest to highest stage: Decided not to do, Not considering, Haven't decided, Decided to Do and Done, with "Done" only possible at endpoint.
Time frame: 6 months
Test Specific Screening Adherence
Test adherence (SBT or endoscopy) will be assessed using 6-month survey and 12-month medical records data. The two study groups will be compared in terms of the fraction of participants who have a screening test within 12 months.
Time frame: 12 Months
Screening Knowledge and Perceptions
Knowledge and perceptions (Preventive Health Model scales) about CRC and screening will be assessed in a 6-month survey. Knowledge was measured by a set of 10 true-false statements about CRC and CRC screening. Knowledge was scored as the number of items correct with a possible range of 0 to 10. Perceptions about CRC and screening were measured using a 20-item scale based on the Preventive Health Model. Items were measured on a 5 point Likert scale ranging from 1 = Strongly Disagree to 5 = Strongly Agree. The total score and subscale scores were computed by taking the mean of component items resulting in scores that could range from 1 to 5, with higher scores indicating more favorable attitudes towards the CRC screening preventive health behavior.
Time frame: 6 months
2,720 study invitation letters sent to subjects from 5 practices that appeared to meet eligibility criteria based on medical records.
| Milestone | Standard | Decision Support & Navigation |
|---|---|---|
| Started | 203 | 197 |
| Completed | 203 | 197 |
| Not completed | 0 | 0 |
The two study groups will be compared in terms of the fraction of participants who undergo CRC screening (through SBT, colonoscopy, flexible sigmoidoscopy, etc.) within 12 months of the randomization date. Screening will be measured using data from the 6-month survey and the 12-month chart audit.
| Participants | Standard | Decision Support & Navigation |
|---|---|---|
| Screened | 88 | 153 |
| Not Screened | 115 | 44 |
At baseline and endpoint (6-month) survey, participants were asked about their decision stage regarding CRC screening. Possible decision stages are, ranked from lowest to highest stage: Decided not to do, Not considering, Haven't decided, Decided to Do and Done, with "Done" only possible at endpoint.
| Participants | Standard | Decision Support & Navigation |
|---|---|---|
| Forward Change | 61 | 97 |
| No Change | 52 | 23 |
| Backward Change | 10 | 3 |
Test adherence (SBT or endoscopy) will be assessed using 6-month survey and 12-month medical records data. The two study groups will be compared in terms of the fraction of participants who have a screening test within 12 months.
| Participants | Standard | Decision Support & Navigation |
|---|---|---|
| None | 115 | 44 |
| Stool Blood Test | 76 | 113 |
| Colonoscopy | 12 | 40 |
Knowledge and perceptions (Preventive Health Model scales) about CRC and screening will be assessed in a 6-month survey. Knowledge was measured by a set of 10 true-false statements about CRC and CRC screening. Knowledge was scored as the number of items correct with a possible range of 0 to 10. Perceptions about CRC and screening were measured using a 20-item scale based on the Preventive Health Model. Items were measured on a 5 point Likert scale ranging from 1 = Strongly Disagree to 5 = Strongly Agree. The total score and subscale scores were computed by taking the mean of component items resulting in scores that could range from 1 to 5, with higher scores indicating more favorable attitudes towards the CRC screening preventive health behavior.
| units on a scale | Standard | Decision Support & Navigation |
|---|---|---|
| Preventive Health Model (PHM) | 3.8 ± 0.5 | 3.8 ± 0.6 |
| PHM: Salience | 4.8 ± 0.5 | 4.7 ± 0.6 |
| PHM: Response Efficacy | 4.5 ± 0.7 | 4.5 ± 0.7 |
| PHM: Susceptibility | 2.6 ± 1.0 | 2.8 ± 1.0 |
| PHM: Worries and Concerns | 3.1 ± 1.1 | 3.1 ± 1.1 |
| PHM: Social Support and Influence | 4.4 ± 0.8 | 4.4 ± 0.9 |
| Knowledge Test | 4.7 ± 1.8 | 4.6 ± 2.1 |
Collected over 1 Year from baseline. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard | 0/203 (0%) | 0/203 (0%) | 0/203 (0%) |
| Decision Support & Navigation | 0/197 (0%) | 0/197 (0%) | 0/197 (0%) |
| Age, Continuous(years) | Standard | Decision Support & Navigation | Total |
|---|---|---|---|
| Mean | 57.5 ± 6.5 | 57.2 ± 6.4 | 57.3 ± 6.5 |
| Age, Customized(Participants) | Standard | Decision Support & Navigation | Total |
|---|---|---|---|
| Age (years) — 50-59 | 140 | 137 | 277 |
| Age (years) — 60-69 | 47 | 48 | 95 |
| Age (years) — 70-79 | 16 | 12 | 28 |
| Sex: Female, Male(Participants) | Standard | Decision Support & Navigation | Total |
|---|---|---|---|
| Female | 118 | 117 | 235 |
| Male | 85 | 80 | 165 |
| Race/Ethnicity, Customized(Participants) | Standard | Decision Support & Navigation | Total |
|---|---|---|---|
| Race — White/Caucasian | 64 | 69 | 133 |
| Race — Black/African American | 61 | 57 | 118 |
| Race — Other | 42 | 49 | 91 |
| Race — Unknown/Not Reported | 36 | 22 | 58 |
| Marital Status(Participants) | Standard | Decision Support & Navigation | Total |
|---|---|---|---|
| Married | 94 | 78 | 172 |
| Living as marreid | 10 | 10 | 20 |
| Divorced | 25 | 26 | 51 |
| Separated | 20 | 13 | 33 |
| Widowed | 7 | 17 | 24 |
| Never married | 47 | 53 | 100 |
| Education(Participants) | Standard | Decision Support & Navigation | Total |
|---|---|---|---|
| Less than HS | 90 | 102 | 192 |
| HS/GED | 58 | 51 | 109 |
| Completed Non-College/Business/Trade/Tech | 13 | 8 | 21 |
| 2-yr Associates | 16 | 19 | 35 |
| College Degree and above | 26 | 17 | 43 |
| Employment Status(Participants) | Standard | Decision Support & Navigation | Total |
|---|---|---|---|
| Working full-time | 44 | 41 | 85 |
| Working part-time | 41 | 35 | 76 |
| Keeping House | 45 | 45 | 90 |
| Unable to Work/Disability | 53 | 62 | 115 |
| Retired | 20 | 14 | 34 |
| Family Income(Participants) | Standard | Decision Support & Navigation | Total |
|---|---|---|---|
| Under $14,999 | 144 | 136 | 280 |
| $15,000-$29,000 | 37 | 45 | 82 |
| $30,000-$45,999 | 18 | 12 | 30 |
| $46,000-$59,999 | 3 | 4 | 7 |
| Unknown/Not Reported | 1 | 0 | 1 |
9 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Thomas Jefferson University