## Protocol Section
### Identification Module
**NCT ID:** NCT01385579

**Brief Title:** Effectiveness of Direct-to-Patient Outreach on Colorectal Cancer Screening Within a Low Income and Diverse Population

**Official Title:** A Randomized Controlled Trial of a Direct-to-Patient Outreach Program to Improve Rates of Colorectal Cancer Screening in a Low Income and Racially Diverse Population

#### Organization Study ID Info
**ID:** STU00015652
#### Organization
**Class:** OTHER
**Full Name:** Northwestern University
### Status Module
#### Completion Date
**Date:** 2010-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-01-06

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-11-18

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2010-06

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2014-01-06

**Type:** ESTIMATED

**Results First Submit Date:** 2013-11-18

**Results First Submit QC Date:** 2013-11-18

#### Start Date
**Date:** 2010-01

**Status Verified Date:** 2013-11

#### Study First Post Date
**Date:** 2011-06-30
**Type:** ESTIMATED
**Study First Submit Date:** 2011-06-28
**Study First Submit QC Date:** 2011-06-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Northwestern University

#### Responsible Party

**Investigator Affiliation:** Northwestern University

**Investigator Full Name:** Bechara Choucair

**Investigator Title:** Adjunct Associate Professor in Family and Community Medicine

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to determine if the direct mailing of fecal occult blood testing (FOBT) kits to patients who are due for colorectal cancer screening is an effective way to improve colorectal cancer screening rates within a low income and racially/ethnically diverse population.

**Detailed Description:** Patients ages 50 to 80 who are identified through the electronic health record as not being up to date on colorectal cancer screening are eligible for the study and will be randomly assigned to the intervention or usual care group. Individuals in the intervention group will be mailed a letter informing them that they are due for colorectal cancer screening, educational material regarding colorectal cancer screening, a fecal occult blood testing (FOBT) kit, directions on how to use and return the FOBT kit. The proportion of patients assigned to the intervention versus usual care groups who complete a guideline recommended form of colorectal cancer screening within 4 months of the initiation of outreach will be compared.

### Conditions Module

**Conditions:**

- Malignant Neoplasm of Large Intestine

**Keywords:**

- colorectal cancer screening

- fecal occult blood testing (FOBT)

- vulnerable populations

- community health center

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 202

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager.

**Label:** usual care

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit

**Intervention Names:**

- Other: Care manager outreach

**Label:** Care manager outreach

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Care manager outreach

**Description:** Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit. Patients who do not respond to the mail outreach received up to 3 attempts at telephone outreach by the care manager.

**Name:** Care manager outreach

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Patients who have documentation within the electronic health record of completion of a guideline approved form of colorectal cancer screening (colonoscopy, sigmoidoscopy, or fecal occult blood testing (FOBT)) within 4 months of the initiation of the outreach intervention (by June 30, 2010)

**Measure:** Completion of a Colorectal Cancer Screening

**Time Frame:** within 4 months of the initiation of outreach (by June 30, 2010)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Ages 50 to 80 as of 12/31/2009 At least 2 visits to the community health center between 7/1/2008 and 12/31/2009

Exclusion criteria:

Documented fecal occult blood testing (FOBT) within 1 year (between 1/1/2009 and 12/31/2009) Documented sigmoidoscopy within 5 years (between 1/1/2005 and 12/31/2009) Documented colonoscopy within 10 years (between 1/1/2000 and 12/31/2009)

**Healthy Volunteers:** True

**Maximum Age:** 80 Years

**Minimum Age:** 50 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Chicago

**Country:** United States

**Facility:** Heartland International Health Center

**State:** Illinois

**Zip:** 60645

#### Overall Officials

**Official 1:**

**Affiliation:** Northwestern University, Feinberg School of Medicine, Department of Family and Community Medicine

**Name:** Bechara N Choucair, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Jean-Jacques M, Kaleba EO, Gatta JL, Gracia G, Ryan ER, Choucair BN. Program to improve colorectal cancer screening in a low-income, racially diverse population: a randomized controlled trial. Ann Fam Med. 2012 Sep-Oct;10(5):412-7. doi: 10.1370/afm.1381.

**PMID:** 22966104

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007414

- Term: Intestinal Neoplasms

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000003108

- Term: Colonic Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000012002

- Term: Rectal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M17890

- Name: Colorectal Neoplasms

- Relevance: HIGH

- As Found: Colorectal Cancer

- ID: M10448

- Name: Intestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6336

- Name: Colonic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14844

- Name: Rectal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000015179

- Term: Colorectal Neoplasms

- ID: D000009369

- Term: Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Usual Care

**Description:** Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager.

**ID:** EG000

**Other Num at Risk:** 98

**Serious Number At Risk:** 98

**Title:** Usual Care

**Group ID:** EG001

**Title:** Care Manager Outreach

**Description:** Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit

**ID:** EG001

**Other Num at Risk:** 104

**Serious Number At Risk:** 104

**Title:** Care Manager Outreach

**Frequency Threshold:** 1

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 98

**Group ID:** BG001

**Value:** 104

**Group ID:** BG002

**Value:** 202

**Units:** Participants

### Group

**ID:** BG000

**Title:** Usual Care

**Description:** Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager.

### Group

**ID:** BG001

**Title:** Care Manager Outreach

**Description:** Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 8

**Value:** 60

#### Measurement

**Group ID:** BG001

**Spread:** 7

**Value:** 60

#### Measurement

**Group ID:** BG002

**Spread:** 8

**Value:** 60

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 58

#### Measurement

**Group ID:** BG001

**Value:** 67

#### Measurement

**Group ID:** BG002

**Value:** 125

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 40

#### Measurement

**Group ID:** BG001

**Value:** 37

#### Measurement

**Group ID:** BG002

**Value:** 77

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Limitations and Caveats
**Description:** Single site study
### Point of Contact
**Email:** mjean@nmff.org
**Organization:** Northwestern University
**Phone:** 312-503-9642
**Title:** Dr. Muriel Jean-Jacques, Assistant professor
## Results Section - Outcome Measures Module
### Outcome Measure 1
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 31
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Patients who have documentation within the electronic health record of completion of a guideline approved form of colorectal cancer screening (colonoscopy, sigmoidoscopy, or fecal occult blood testing (FOBT)) within 4 months of the initiation of the outreach intervention (by June 30, 2010)
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** within 4 months of the initiation of outreach (by June 30, 2010)
**Title:** Completion of a Colorectal Cancer Screening
**Type:** PRIMARY
**Unit of Measure:** participants
##### Group
**Description:** Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager.
**ID:** OG000
**Title:** Usual Care
##### Group
**Description:** Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit
**ID:** OG001
**Title:** Care Manager Outreach
### Participant Flow Module
#### Group
**Description:** Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager.
**ID:** FG000
**Title:** Usual Care
#### Group
**Description:** Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit
**ID:** FG001
**Title:** Care Manager Outreach
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 98
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 104
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 98
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 104
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Recruitment Details:** All eligible patients within the health center were randomized to usual care or care manager outreach. Eligibility for randomization was assessed on 12/31/2009. Outreach was conducted from 2/25/2010 through 4/30/2010.
**Has Results:** True