Colorectal Cancer
Conditions
Keywords
Cancer Screening, Colonoscopy, Community Health Centers, Implementation Science, Patient Navigation
Brief summary
This study will test the effectiveness of mailing fecal immunochemical tests (FITs) in increasing colorectal cancer (CRC) screening rates in U.S. adults ages 45-75. We are implementing this study in two age groups, 45-49 years and 50-75 years.
Detailed description
Trial (Age Group 50-75) This randomized controlled trial assesses the effectiveness, feasibility, acceptability, and cost-effectiveness of mailing FITs from a central location to patients served by FQHCs. Subjects are randomly selected and assigned to receive either a mailed FIT intervention (Arm 1: Trial Mailed FIT Intervention - Age Group 50-75) or usual care (Arm 2: Trial Usual Care - Age Group 50-75). To assess United States Preventive Services Task Force recommendations for annual screening, we will mail subjects one round of FIT per year for up to two years. Sub-study (Age Group 45-49) A sub-study assesses the effectiveness of mailing FITs from a central location to patients who are 45-49 years of age and newly eligible for CRC screening. The sub-study also assesses the impact of varying the appearance of the FIT packet mailing envelope on FIT return. All eligible patients from one FQHC clinic site are randomly assigned to receive either a mailed FIT intervention that includes an enhanced mailing envelope (Arm 3: Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49) or a plain envelope (Arm 4: Sub-study Mailed FIT Active Comparator Plain Envelope - Age Group 45-49). The Trial (Age Group 50-75) and the Sub-study (Age Group 45-49) also assess the effectiveness of delivering patient navigation from a central location to facilitate follow up colonoscopy for patients with a positive (abnormal) FIT result.
Interventions
BEHAVIORALTrial Mailed FIT Intervention - Age Group 50-75
Subjects are mailed an introductory letter advising them that they will receive a FIT kit in the mail. Next, subjects are mailed a FIT packet in an envelope that contains a cover letter, CRC information sheet, FIT instruction sheet, and FIT kit with a pre-paid return envelope. Subjects receive up to two mailed letters reminding them to complete and return the FIT. Subjects receive FIT results via letter or phone call.
BEHAVIORALSub-Study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49
Subjects are mailed an introductory letter advising them that they will receive a FIT kit in the mail. Next, subjects are mailed a FIT packet in an enhanced envelope that contains a cover letter, CRC information sheet, FIT instruction sheet, and FIT kit with a pre-paid return envelope. The enhanced envelope is a yellow padded envelope with a USPS tracking label and sticker message: "Important information from your doctor". Subjects receive up to two mailed letters reminding them to complete and return the FIT. Subjects receive FIT results via letter or phone call.
BEHAVIORALSub-Study Mailed FIT Active Comparator Plain Envelope - Age Group 45-49
Subjects are mailed an introductory letter advising them that they will receive a FIT kit in the mail. Next, subjects are mailed a FIT packet in plain envelope that contains a cover letter, CRC information sheet, FIT instruction sheet, and FIT kit with a pre-paid return envelope. The plain envelope is a white envelope without a USPS tracking label or sticker message. Subjects receive up to two mailed letters reminding them to complete and return the FIT. Subjects receive FIT results via letter or phone call.
Sponsors
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
East Carolina University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Trial (Age Group 50-75) Using a randomized controlled trial study design, subjects are assigned to one of two arms: Arm 1: Trial Mailed FIT Intervention; or Arm 2: Trial Usual Care. Arm 1 (intervention) receives a mailed FIT plus up to two reminder letters. Subjects are randomized 1:1 at baseline and remain in their assigned arm for the duration of the study (i.e., two annual rounds of mailed FIT). Sub-study (Age Group 45-49) Subjects, ages 45-49, are randomly assigned to one of two arms: Arm 3: Sub-Study Mailed FIT Intervention - Enhanced Envelope; or Arm 4: Sub-study Mailed FIT Active Comparator Plain Envelope. Subjects in both Arm 3 and Arm 4 receive mailed FIT plus up to two reminder letters. Subjects are randomized 1:1 at baseline and remain in their assigned arm for the duration of the sub-study (i.e., one annual round of mailed FIT).
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 45-75 years * At average risk for CRC ("average risk" is defined as those patients who do not have any of the following: documented history of CRC, colorectal neoplasms, colorectal polyps, colonic adenomas, family history of CRC among first degree relative \[father, mother, sister, brother\], or diagnosis of inflammatory bowel disease) * No record of fecal occult blood test (FOBT)/FIT within the past 12 months or colonoscopy within 10 years, sigmoidoscopy within 5 years, barium enema within 5 years, or computed tomography (CT) colonography within 10 years of the EHR query date * No record of any CRC diagnosis or total colectomy * No record of comorbidities or screening contraindications, including dementia, hospice care, assisted living, end-stage renal disease, and other cancers (glioblastoma, pancreatic cancer, lung cancer, esophageal cancer, liver and bile duct cancer, mesothelioma) * Has a complete North Carolina mailing address in the EHR * Active patient of the clinic (seen within the past 18 months) at the time of randomization * No record of a positive (abnormal) FIT result in the first study round (Trial Ages 50-75 only)
Exclusion criteria
* Age younger than 45 years or older than 75 years * Not at average risk for CRC ("average risk" is defined as those patients who do not have any of the following: documented history of CRC, colorectal neoplasms, colorectal polyps, colonic adenomas, family history of CRC among first degree relative \[father, mother, sister, brother\], or diagnosis of inflammatory bowel disease) * Record of FOBT/FIT within the past 12 months or colonoscopy within 10 years, sigmoidoscopy within 5 years, barium enema within 5 years, or CT colonography within 10 years of the EHR query date * Record of any CRC diagnosis or total colectomy * Record of comorbidities or screening contraindications, including dementia, hospice care, assisted living, end-stage renal disease, and other cancers (glioblastoma, pancreatic cancer, lung cancer, esophageal cancer, liver and bile duct cancer, mesothelioma) * Does not have a complete North Carolina mailing address in the EHR * Not an active patient of the clinic (not seen within the past 18 months) at the time of randomization * Record of a positive (abnormal) FIT result reported during the first study round (Trial Ages 50-75)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Who Completed Colorectal Cancer (CRC) Screening Within 6 Months (Trial - Age Group 50-75) | Up to 6 months after randomization | "The proportion of subjects who received study Intervention (Age Group 50-75) and did not receive study intervention (Usual Care - Age Group 50-75 who completed CRC screening using any of the screening modalities recommended by the United States Preventive Services Task Force per electronic health record review. Fecal immunochemical test (FIT), fecal occult blood test \[FOBT\], fecal immunochemical test - deoxyribonucleic acid (FIT-DNA), colonoscopy, flexible sigmoidoscopy, flexible sigmoidoscopy with FIT, Computerized Tomography colonography." |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subject Colorectal Carcinoma (CRC) and Advanced Adenomas Detected at 12 Months | Up to 12 months after screening or diagnostic colonoscopy result date | Number of CRCs and advanced adenomas detected among subjects who received study Intervention (Age Group 50-75) and subjects who did not receive study intervention (Usual Care only - Age Group 50-75) per electronic health record review. |
| Proportion of Subjects Who Returned a Completed Mailed FIT at 60 Days | Up to 60 days after randomization | The proportion of subjects who received study Intervention (Age Group - 50-75) and returned a completed FIT per electronic health record review. |
| Number of Days From CRC Diagnosis to the Date of Evaluation for CRC Treatment | Up to 12 months after CRC diagnosis | Number of days from CRC diagnosis to the date of evaluation for CRC treatment among subjects who received study Intervention (Age Group 50-75) and subjects who did not receive study intervention (Usual Care - Age Group 50-75) using electronic health record data to ascertain the dates of CRC diagnosis and evaluation for CRC treatment. |
| Number of Subjects Who Received Referral for Cancer Treatment | Up to 6 months after cancer diagnosis date | Number of subjects who received study Intervention (Age Group 50-75) and did not receive intervention (Age Group 50-75) who received referral for cancer treatment among individuals diagnosed with CRC per electronic health record review. |
| Number of Subjects Mailed FITs Completed After Two Rounds of Annual FIT Outreach | Round 1 time frame: at 6 months after randomization; Round 2 time frame: at 6 months after determining eligibility for Round 2 | "Number of annual FIT screenings completed (0, 1, or 2) by subjects who received Intervention (Age Group 50-75) after two annual rounds of mailed FIT outreach per electronic health record review. |
| Incremental Cost of Each Additional Patient Screened in the Intervention Arm Compared to Usual Care (Trial - Age Group 50-75) | Through study completion, up to 36 months after randomization | Comparison of the programmatic costs incurred and number of subjects screened in Arm 1(Trial Mailed FIT Intervention - Age Group 50-75) compared to Arm 2 (Trial Usual Care - Age Group 50-75), measured as cost of intervention minus the cost of usual care, divided by the number screened in Arm 1 minus the number screened in Arm 2. Intervention costs will be assessed using periodic episodes of direct observation of mailed FIT outreach activities, time logs maintained by the intervention team, and assembly of administrative data capturing non-personnel/non-labor expenditures, such as costs associated with materials printing, FIT processing, and mailing costs. Usual care costs will be assessed using a combination of clinic observations and interviews with staff. |
| The Proportion of Subjects, Ages 45-49, Who Are Current With CRC Screening | Up to 6 months after randomization | The proportion of subjects in Arm 3 (Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49) and Arm 4 (Sub-study Mailed FIT Active Comparator Envelope - Age Group 45-49) who are current with any CRC screening compared to baseline, using any of the screening modalities recommended by the United States Preventive Services Task Force (FIT, fecal occult blood test \[FOBT\], FIT-DNA, colonoscopy, flexible sigmoidoscopy, flexible sigmoidoscopy with FIT, CT colonography) per electronic health record review. |
| Proportion of Subjects, Ages 45-49, Who Completed Mailed FIT at 60 Days | 60 days after randomization | The proportion of subjects in Arm 3 (Intervention Enhanced Envelope - Age Group 45-49) compared to subjects in Arm 4 (Intervention Active Comparator Envelope - Age Group 45-49) who returned a completed FIT. |
| Proportion of Subjects Who Completed a Follow-up (Diagnostic) Colonoscopy | Up to 6 months after diagnostic colonoscopy referral date | The proportion of subjects who received study Intervention (Age Group 50-75) and did not receive study information (Usual Care only - Age Group 50-75), who had a positive (abnormal) FIT/FOBT result, and for whom colonoscopy was deemed to be clinically appropriate by the subject's provider, who completed follow-up (diagnostic) colonoscopy per electronic health record review. |
| Proportion of Subjects Who Completed a Follow up (Diagnostic) Colonoscopy | Up to 6 months after abnormal FIT result date | The proportion of subjects in Arm 3 (Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49) and Arm 4 (Sub-study Mailed FIT Active Comparator Plain Envelope - Age Group 45-40) with a positive (abnormal) FIT/FOBT result for whom colonoscopy is deemed to be clinically appropriate by the subject's provider who completes a follow-up (diagnostic) colonoscopy per electronic health record review. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDaniel S Reuland, MD
University of North Carolina, Chapel Hill
Participant flow
Pre-assignment details
Subjects were enrolled between 07/07/2020 - 02/28/2022 in one center in North Carolina.
Participants by arm
| Arm | Count |
|---|---|
| Experimental: Trial Mailed FIT - Age Group 50-75 Subjects randomized to this arm are 50-75 years of age and eligible for CRC screening using FIT per electronic health record at either of the two study sites. This arm receives a mailed FIT and up to two reminder letters. | 2,001 |
| No Intervention: Trial Usual Care - Age Group 50-75 Subjects randomized to this arm are 50-75 years of age and eligible for CRC screening using FIT per electronic health record at either of the two study sites. This arm receives the usual care. | 2,001 |
| Experimental: Sub-study Mailed FIT Age Group 45-49 Enhanced Envelope Subjects randomized to this arm are 45-49 years of age and eligible for CRC screening using FIT per electronic health record at one study site. This arm receives a mailed FIT in an enhanced mailing envelope and up to two reminder letters. | 158 |
| Active Comparator: Sub-study Mailed FIT Comparator Plain Envelope - Age Group 45-49 Subjects randomized to this arm are 45-49 years of age and eligible for CRC screening using FIT per electronic health record at one study site. This arm receives a mailed FIT in a plain envelope and up to two reminder letters. | 158 |
| Total | 4,318 |
Baseline characteristics
| Characteristic | Total | Experimental: Trial Mailed FIT - Age Group 50-75 | No Intervention: Trial Usual Care - Age Group 50-75 | Experimental: Sub-study Mailed FIT Age Group 45-49 Enhanced Envelope | Active Comparator: Sub-study Mailed FIT Comparator Plain Envelope - Age Group 45-49 |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1019 Participants | 514 Participants | 505 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3299 Participants | 1487 Participants | 1496 Participants | 158 Participants | 158 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 389 Participants | 185 Participants | 179 Participants | 13 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3652 Participants | 1687 Participants | 1679 Participants | 141 Participants | 145 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 277 Participants | 129 Participants | 143 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 15 Participants | 4 Participants | 8 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 30 Participants | 17 Participants | 10 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1269 Participants | 549 Participants | 536 Participants | 88 Participants | 96 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 5 Participants | 3 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 338 Participants | 156 Participants | 151 Participants | 18 Participants | 13 Participants |
| Race (NIH/OMB) White | 2661 Participants | 1272 Participants | 1295 Participants | 50 Participants | 44 Participants |
| Region of Enrollment United States | 4318 Participants | 2001 Participants | 2001 Participants | 158 Participants | 158 Participants |
| Sex: Female, Male Female | 2437 Participants | 1135 Participants | 1121 Participants | 84 Participants | 97 Participants |
| Sex: Female, Male Male | 1881 Participants | 866 Participants | 880 Participants | 74 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Proportion of Subjects Who Completed Colorectal Cancer (CRC) Screening Within 6 Months (Trial - Age Group 50-75)
The proportion of subjects who received study Intervention (Age Group 50-75) and did not receive study intervention (Usual Care - Age Group 50-75 who completed CRC screening using any of the screening modalities recommended by the United States Preventive Services Task Force per electronic health record review. Fecal immunochemical test (FIT), fecal occult blood test \[FOBT\], fecal immunochemical test - deoxyribonucleic acid (FIT-DNA), colonoscopy, flexible sigmoidoscopy, flexible sigmoidoscopy with FIT, Computerized Tomography colonography.
Time frame: Up to 6 months after randomization
Population: Subjects who actively receive health care from the study sites, aged between 50-75.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Trial Mailed FIT Intervention - Age Group 50-75 | Proportion of Subjects Who Completed Colorectal Cancer (CRC) Screening Within 6 Months (Trial - Age Group 50-75) | 598 Participants |
| Trial Usual Care - Age Group 50-75 | Proportion of Subjects Who Completed Colorectal Cancer (CRC) Screening Within 6 Months (Trial - Age Group 50-75) | 192 Participants |
Secondary
Incremental Cost of Each Additional Patient Screened in the Intervention Arm Compared to Usual Care (Trial - Age Group 50-75)
Comparison of the programmatic costs incurred and number of subjects screened in Arm 1(Trial Mailed FIT Intervention - Age Group 50-75) compared to Arm 2 (Trial Usual Care - Age Group 50-75), measured as cost of intervention minus the cost of usual care, divided by the number screened in Arm 1 minus the number screened in Arm 2. Intervention costs will be assessed using periodic episodes of direct observation of mailed FIT outreach activities, time logs maintained by the intervention team, and assembly of administrative data capturing non-personnel/non-labor expenditures, such as costs associated with materials printing, FIT processing, and mailing costs. Usual care costs will be assessed using a combination of clinic observations and interviews with staff.
Time frame: Through study completion, up to 36 months after randomization
Secondary
Number of Days From CRC Diagnosis to the Date of Evaluation for CRC Treatment
Number of days from CRC diagnosis to the date of evaluation for CRC treatment among subjects who received study Intervention (Age Group 50-75) and subjects who did not receive study intervention (Usual Care - Age Group 50-75) using electronic health record data to ascertain the dates of CRC diagnosis and evaluation for CRC treatment.
Time frame: Up to 12 months after CRC diagnosis
Population: Participants were diagnosed with CRC ever during Round 1. Five subjects from Trial Mailed FIT Intervention - Age Group 50-75 and 2 subjects from Trial Usual Care - Age Group 50-75 were evaluated for treatment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Trial Mailed FIT Intervention - Age Group 50-75 | Number of Days From CRC Diagnosis to the Date of Evaluation for CRC Treatment | 3.25 days |
| Trial Usual Care - Age Group 50-75 | Number of Days From CRC Diagnosis to the Date of Evaluation for CRC Treatment | 0 days |
Secondary
Number of Subject Colorectal Carcinoma (CRC) and Advanced Adenomas Detected at 12 Months
Number of CRCs and advanced adenomas detected among subjects who received study Intervention (Age Group 50-75) and subjects who did not receive study intervention (Usual Care only - Age Group 50-75) per electronic health record review.
Time frame: Up to 12 months after screening or diagnostic colonoscopy result date
Population: Subjects who participated to the study and were diagnosed with colorectal carcinoma.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Trial Mailed FIT Intervention - Age Group 50-75 | Number of Subject Colorectal Carcinoma (CRC) and Advanced Adenomas Detected at 12 Months | 22 Participants |
| Trial Usual Care - Age Group 50-75 | Number of Subject Colorectal Carcinoma (CRC) and Advanced Adenomas Detected at 12 Months | 8 Participants |
Secondary
Number of Subjects Mailed FITs Completed After Two Rounds of Annual FIT Outreach
Number of annual FIT screenings completed (0, 1, or 2) by subjects who received Intervention (Age Group 50-75) after two annual rounds of mailed FIT outreach per electronic health record review.
Time frame: Round 1 time frame: at 6 months after randomization; Round 2 time frame: at 6 months after determining eligibility for Round 2
Population: Subjects who are 50-75 years old received study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Trial Mailed FIT Intervention - Age Group 50-75 | Number of Subjects Mailed FITs Completed After Two Rounds of Annual FIT Outreach | 1372 Participants |
| Trial Usual Care - Age Group 50-75 | Number of Subjects Mailed FITs Completed After Two Rounds of Annual FIT Outreach | 261 Participants |
| Completed 1 Annual FIT Screening Only in Year 2 | Number of Subjects Mailed FITs Completed After Two Rounds of Annual FIT Outreach | 116 Participants |
| Completed 2 Annual FIT Screenings in Year 1 and Year 2 | Number of Subjects Mailed FITs Completed After Two Rounds of Annual FIT Outreach | 252 Participants |
Secondary
Number of Subjects Who Received Referral for Cancer Treatment
Number of subjects who received study Intervention (Age Group 50-75) and did not receive intervention (Age Group 50-75) who received referral for cancer treatment among individuals diagnosed with CRC per electronic health record review.
Time frame: Up to 6 months after cancer diagnosis date
Population: Subjects who received a referral for cancer treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Trial Mailed FIT Intervention - Age Group 50-75 | Number of Subjects Who Received Referral for Cancer Treatment | 4 Participants |
| Trial Usual Care - Age Group 50-75 | Number of Subjects Who Received Referral for Cancer Treatment | 2 Participants |
Secondary
Proportion of Subjects, Ages 45-49, Who Completed Mailed FIT at 60 Days
The proportion of subjects in Arm 3 (Intervention Enhanced Envelope - Age Group 45-49) compared to subjects in Arm 4 (Intervention Active Comparator Envelope - Age Group 45-49) who returned a completed FIT.
Time frame: 60 days after randomization
Population: Subjects who are between 45-49 old completed mailed FIT at 60 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Trial Mailed FIT Intervention - Age Group 50-75 | Proportion of Subjects, Ages 45-49, Who Completed Mailed FIT at 60 Days | 34 Participants |
| Trial Usual Care - Age Group 50-75 | Proportion of Subjects, Ages 45-49, Who Completed Mailed FIT at 60 Days | 20 Participants |
Secondary
Proportion of Subjects Who Completed a Follow up (Diagnostic) Colonoscopy
The proportion of subjects in Arm 3 (Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49) and Arm 4 (Sub-study Mailed FIT Active Comparator Plain Envelope - Age Group 45-40) with a positive (abnormal) FIT/FOBT result for whom colonoscopy is deemed to be clinically appropriate by the subject's provider who completes a follow-up (diagnostic) colonoscopy per electronic health record review.
Time frame: Up to 6 months after abnormal FIT result date
Population: Subjects who are 45-49 years old completed study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Trial Mailed FIT Intervention - Age Group 50-75 | Proportion of Subjects Who Completed a Follow up (Diagnostic) Colonoscopy | positive (abnormal) FIT/FOBT result | 2 Participants |
| Trial Mailed FIT Intervention - Age Group 50-75 | Proportion of Subjects Who Completed a Follow up (Diagnostic) Colonoscopy | completed a follow-up colonoscopy | 2 Participants |
| Trial Usual Care - Age Group 50-75 | Proportion of Subjects Who Completed a Follow up (Diagnostic) Colonoscopy | positive (abnormal) FIT/FOBT result | 1 Participants |
| Trial Usual Care - Age Group 50-75 | Proportion of Subjects Who Completed a Follow up (Diagnostic) Colonoscopy | completed a follow-up colonoscopy | 1 Participants |
Secondary
Proportion of Subjects Who Completed a Follow-up (Diagnostic) Colonoscopy
The proportion of subjects who received study Intervention (Age Group 50-75) and did not receive study information (Usual Care only - Age Group 50-75), who had a positive (abnormal) FIT/FOBT result, and for whom colonoscopy was deemed to be clinically appropriate by the subject's provider, who completed follow-up (diagnostic) colonoscopy per electronic health record review.
Time frame: Up to 6 months after diagnostic colonoscopy referral date
Population: Subjects who started the study and were assessed for colon carcinoma within 6 months.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Trial Mailed FIT Intervention - Age Group 50-75 | Proportion of Subjects Who Completed a Follow-up (Diagnostic) Colonoscopy | Abnormal FIT | 48 Participants |
| Trial Mailed FIT Intervention - Age Group 50-75 | Proportion of Subjects Who Completed a Follow-up (Diagnostic) Colonoscopy | Completed colonoscopy | 33 Participants |
| Trial Usual Care - Age Group 50-75 | Proportion of Subjects Who Completed a Follow-up (Diagnostic) Colonoscopy | Abnormal FIT | 18 Participants |
| Trial Usual Care - Age Group 50-75 | Proportion of Subjects Who Completed a Follow-up (Diagnostic) Colonoscopy | Completed colonoscopy | 8 Participants |
Secondary
Proportion of Subjects Who Returned a Completed Mailed FIT at 60 Days
The proportion of subjects who received study Intervention (Age Group - 50-75) and returned a completed FIT per electronic health record review.
Time frame: Up to 60 days after randomization
Population: Subjects who actively receive health care from the study sites, aged between 50-75.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Trial Mailed FIT Intervention - Age Group 50-75 | Proportion of Subjects Who Returned a Completed Mailed FIT at 60 Days | 409 Participants |
Secondary
The Proportion of Subjects, Ages 45-49, Who Are Current With CRC Screening
The proportion of subjects in Arm 3 (Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49) and Arm 4 (Sub-study Mailed FIT Active Comparator Envelope - Age Group 45-49) who are current with any CRC screening compared to baseline, using any of the screening modalities recommended by the United States Preventive Services Task Force (FIT, fecal occult blood test \[FOBT\], FIT-DNA, colonoscopy, flexible sigmoidoscopy, flexible sigmoidoscopy with FIT, CT colonography) per electronic health record review.
Time frame: Up to 6 months after randomization
Population: Screening-eligible population, aged 45-49 years old.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Trial Mailed FIT Intervention - Age Group 50-75 | The Proportion of Subjects, Ages 45-49, Who Are Current With CRC Screening | Screening-eligible population, aged 45-49 years old | 158 Participants |
| Trial Mailed FIT Intervention - Age Group 50-75 | The Proportion of Subjects, Ages 45-49, Who Are Current With CRC Screening | Count of screened participants | 53 Participants |
| Trial Usual Care - Age Group 50-75 | The Proportion of Subjects, Ages 45-49, Who Are Current With CRC Screening | Screening-eligible population, aged 45-49 years old | 158 Participants |
| Trial Usual Care - Age Group 50-75 | The Proportion of Subjects, Ages 45-49, Who Are Current With CRC Screening | Count of screened participants | 45 Participants |