## Protocol Section
### Identification Module
**NCT ID:** NCT03907579

**Acronym:** S2S

**Brief Title:** Screen to Save: A Colorectal Cancer Educational Intervention

**Official Title:** Screen to Save: A Colorectal Cancer Educational Intervention

#### Organization Study ID Info
**ID:** D17190
#### Organization
**Class:** OTHER
**Full Name:** Dartmouth-Hitchcock Medical Center
#### Secondary ID Infos
**ID:** P30CA023108-39
**Link:** https://reporter.nih.gov/quickSearch/P30CA023108-39
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2017-06-17

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-09-04

**Type:** ACTUAL

**Last Update Submit Date:** 2020-08-19

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-06-17

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2020-09-04

**Type:** ACTUAL

**Results First Submit Date:** 2020-07-08

**Results First Submit QC Date:** 2020-08-19

#### Start Date
**Date:** 2017-03-11

**Type:** ACTUAL

**Status Verified Date:** 2020-08

#### Study First Post Date
**Date:** 2019-04-09
**Type:** ACTUAL
**Study First Submit Date:** 2019-04-06
**Study First Submit QC Date:** 2019-04-06
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Cancer Institute (NCI)

#### Lead Sponsor

**Class:** OTHER

**Name:** Dartmouth-Hitchcock Medical Center

#### Responsible Party

**Investigator Affiliation:** Dartmouth-Hitchcock Medical Center

**Investigator Full Name:** Tracy L. Onega

**Investigator Title:** Associate Director of Community Outreach and Education, Norris Cotton Cancer Center; Associate Professor, Dartmouth Geisel School of Medicine

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this research is to understand if an educational program about colorectal cancer helps improve people's knowledge of colorectal cancer prevention and screening and their intention to get screened for colorectal cancer.

### Conditions Module

**Conditions:**

- Colorectal Cancer

**Keywords:**

- Knowledge

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SCREENING

#### Enrollment Info

**Count:** 100

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants attend a brief educational presentation in an inflatable colon, focused on colorectal cancer prevention and screening. Participants also receive a copy of the study information sheet and may receive written educational materials to take home. Participants complete a pre-test and a post-test to assess changes in knowledge and intention to get screened for colorectal cancer.

**Intervention Names:**

- Behavioral: Inflatable colon educational module

**Label:** Inflatable colon educational module

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Inflatable colon educational module

**Description:** Participants attend a brief educational presentation in an inflatable colon, learning about colorectal cancer prevention and screening.

**Name:** Inflatable colon educational module

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** A pre-test and post-test is conducted with participants to assess any changes in knowledge related to key learning outcomes expected from the educational intervention (assessed via 14 questions before and after learning).

**Measure:** Change in Knowledge Related to Colorectal Cancer Risk, Prevention, and Screening

**Time Frame:** Baseline and immediately following intervention

**Description:** Post-test conducted to assess behavioral intention related to five prevention and screening behaviors (assessed via 5 questions on a 4-point Likert scale, where a higher score indicates stronger behavioral intention). The scale for all behavioral intention measures started with, "As a result of the colorectal cancer screening information I received during the Screen to Save educational session, I am more likely to..."

**Measure:** Number of Participants With Varying Levels of Behavioral Intentions Related to Colorectal Cancer Screening and Prevention

**Time Frame:** Immediately following intervention

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age: 50-74 years old
* Attendee at event where educational module is offered

**Healthy Volunteers:** True

**Maximum Age:** 74 Years

**Minimum Age:** 50 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Lebanon

**Country:** United States

**Facility:** Norris Cotton Cancer Center

**State:** New Hampshire

**Zip:** 03756

#### Overall Officials

**Official 1:**

**Affiliation:** Dartmouth College

**Name:** Tracy Onega, PhD, MA, MS

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** For meta-analyses

**Description:** All of the individual de-identified data collected during the trial will be shared with the National Cancer Institute, Geographic Management of Cancer Health Disparities Program (GMaP) contacts, and NCI's designated contractor for the Screen to Save Initiative

**Info Types:**

- STUDY_PROTOCOL

- SAP

**IPD Sharing:** YES

**Time Frame:** Immediately following data collection events

## Document Section

### Large Document Module

#### Large Docs

- Date: 2017-12-13

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 402529

- Type Abbrev: Prot

- Upload Date: 2020-06-24T15:36

- Date: 2017-03-07

- Filename: ICF_001.pdf

- Has ICF: True

- Has Protocol: False

- Has SAP: False

- Label: Informed Consent Form

- Size: 234840

- Type Abbrev: ICF

- Upload Date: 2020-06-24T15:53

- Date: 2020-07-08

- Filename: SAP_002.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 516511

- Type Abbrev: SAP

- Upload Date: 2020-07-09T10:55

## 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: D000009369

- Term: Neoplasms

- 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

### Intervention Browse Module - Browse Branches

- Abbrev: HB

- Name: Herbal and Botanical

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T120

- Name: Cola

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Inflatable Colon Educational Module

**Deaths Num At Risk:** 100

**Description:** Participants attend a brief educational presentation in an inflatable colon, focused on colorectal cancer prevention and screening. Participants also receive a copy of the study information sheet and may receive written educational materials to take home. Participants complete a pre-test and a post-test to assess changes in knowledge and intention to get screened for colorectal cancer.

Inflatable colon educational module: Participants attend a brief educational presentation in an inflatable colon, learning about colorectal cancer prevention and screening.

**ID:** EG000

**Other Num at Risk:** 100

**Serious Number At Risk:** 100

**Title:** Inflatable Colon Educational Module

**Frequency Threshold:** 0

**Time Frame:** During presentation, up to 1 day

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 100

**Units:** Participants

### Group

**ID:** BG000

**Title:** Inflatable Colon Educational Module

**Description:** Participants attend a brief educational presentation in an inflatable colon, focused on colorectal cancer prevention and screening. Participants also receive a copy of the study information sheet and may receive written educational materials to take home. Participants complete a pre-test and a post-test to assess changes in knowledge and intention to get screened for colorectal cancer.

Inflatable colon educational module: Participants attend a brief educational presentation in an inflatable colon, learning about colorectal cancer prevention and screening.

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 5.75

**Value:** 59.5

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 98

**Class Title:** Mean age

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 92

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 8

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 100

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 100

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 100

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 96

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 3

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 100

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 100

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 100

**Class Title:** United States

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 2.20

**Value:** 10.78

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 100

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** Two participants did not provide their age in the baseline survey.
**Title:** Age, Customized
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
### Measure 6
**Description:** Number of correct responses to a series of 14 true/false and multiple-choice test questions about colorectal cancer risks, prevention, and screening.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Correct Answers on Knowledge Questions
**Unit of Measure:** correct answers
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** nccc.community.outreach@dartmouth.edu
**Organization:** Dartmouth-Hitchcock Norris Cotton Cancer Center
**Phone:** 603-653-9960
**Title:** Director of Community Education and Prevention
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0001
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** z= -3.861
**Statistical Method:** Wilcoxon Signed Rank Test
**Tested Non-Inferiority:** 
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -4
- **Spread:** 
- **Upper Limit:** 6
- **Value:** 1
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 71
**Title:** Strongly agree
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 28
**Title:** Agree
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** Disagree
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** Strongly Disagree
**Denomination:**
- **Group ID:** OG000
- **Value:** 99
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 67
**Title:** Strongly agree
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 30
**Title:** Agree
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** Disagree
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** Strongly Disagree
**Denomination:**
- **Group ID:** OG000
- **Value:** 99
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 64
**Title:** Strongly agree
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 30
**Title:** Agree
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** Disagree
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** Strongly Disagree
**Denomination:**
- **Group ID:** OG000
- **Value:** 98
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 72
**Title:** Strongly agree
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 27
**Title:** Agree
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** Disagree
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** Strongly Disagree
**Denomination:**
- **Group ID:** OG000
- **Value:** 99
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 70
**Title:** Strongly agree
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 29
**Title:** Agree
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** Disagree
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** Strongly Disagree
**Denomination:**
- **Group ID:** OG000
- **Value:** 100
**Units:** Participants
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** A pre-test and post-test is conducted with participants to assess any changes in knowledge related to key learning outcomes expected from the educational intervention (assessed via 14 questions before and after learning).
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** Baseline and immediately following intervention
**Title:** Change in Knowledge Related to Colorectal Cancer Risk, Prevention, and Screening
**Type:** PRIMARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Participants attend a brief educational presentation in an inflatable colon, focused on colorectal cancer prevention and screening. Participants also receive a copy of the study information sheet and may receive written educational materials to take home. Participants complete a pre-test and a post-test to assess changes in knowledge and intention to get screened for colorectal cancer.

Inflatable colon educational module: Participants attend a brief educational presentation in an inflatable colon, learning about colorectal cancer prevention and screening.
**ID:** OG000
**Title:** Inflatable Colon Educational Module
#### Outcome Measure 2
**Description:** Post-test conducted to assess behavioral intention related to five prevention and screening behaviors (assessed via 5 questions on a 4-point Likert scale, where a higher score indicates stronger behavioral intention). The scale for all behavioral intention measures started with, "As a result of the colorectal cancer screening information I received during the Screen to Save educational session, I am more likely to..."
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Four intention questions were left blank/unanswered by one to two participants each.
**Reporting Status:** POSTED
**Time Frame:** Immediately following intervention
**Title:** Number of Participants With Varying Levels of Behavioral Intentions Related to Colorectal Cancer Screening and Prevention
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants attend a brief educational presentation in an inflatable colon, focused on colorectal cancer prevention and screening. Participants also receive a copy of the study information sheet and may receive written educational materials to take home. Participants complete a pre-test and a post-test to assess changes in knowledge and intention to get screened for colorectal cancer.

Inflatable colon educational module: Participants attend a brief educational presentation in an inflatable colon, learning about colorectal cancer prevention and screening.
**ID:** OG000
**Title:** Inflatable Colon Educational Module
### Participant Flow Module
#### Group
**Description:** Participants attend a brief educational presentation in an inflatable colon, focused on colorectal cancer prevention and screening. Participants also receive a copy of the study information sheet and may receive written educational materials to take home. Participants complete a pre-test and a post-test to assess changes in knowledge and intention to get screened for colorectal cancer.

Inflatable colon educational module: Participants attend a brief educational presentation in an inflatable colon, learning about colorectal cancer prevention and screening.
**ID:** FG000
**Title:** Inflatable Colon Educational Module
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 100
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 100
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
**Has Results:** True