Colorectal Cancer, CRC, Behavior
Conditions
Keywords
Colorectal Screening behaviors
Brief summary
To determine the unmet needs, attitudes, barriers and facilitators of African American (AA)/ Black men use of colorectal cancer screening and describe how community leaders such as barbers may act as Community Champions to educate and facilitate screening participation.
Interventions
BEHAVIORALmHealth Application
Self-directed application (app) that is downloaded to the participant's personal device. The app contains five informational videos, that provide an orientation to the content on the app, and discuss what colorectal cancer is, and the type of CRC screening tests that are available as well as a video with a personal history. There is a a National Cancer Institute (NCI) risk calculation tool, and a family history infographic. Once the videos have been viewed participants have the option to indicate if they wish to receive a call from the healthcare clinic to discuss scheduling an appointment for screening.
Sponsors
National Cancer Institute (NCI)
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to 74 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult men * Identify as Black or African American * Work or live in Petersburg, VA or surrounding counties * Eligible for colorectal cancer (CRC) screening at time of study enrollment
Exclusion criteria
* Inability to speak or read English * Currently up-to-date with CRC screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Colorectal Screening Status | 3 Months | The number of participants that complete screening (any type) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine Feasibility of Mobile Health (mHealth) Application -Enrollment | Week 1 | The number of men that enroll for the intervention (application) |
| Determine the Feasibility of the mHealth Application-Videos | Week 1 | The number of participants that view the videos |
| Determine the Feasibility of the mHealth Application- Retention | Baseline (Day 1), Week 2, and Week 12 | The number of participants that complete Questionnaires (\>65%) |
| Determine the Feasibility of the mHealth Application- Clinic/ Screening Request | Week 12 | The number of participants that respond to the request to contact clinic/ navigation services |
| Determine the Feasibility of the mHealth Application - Sharing Content | Week 12 | The number of participants that share content on social network |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tailored Screen to Save (S2S) Content Content to be delivered using a combination of short video and text-based information optimized for delivery via Quick Response (QR) codes for smartphones.
mHealth Application: Self-directed application (app) that is downloaded to the participant's personal device. The app contains five informational videos, that provide an orientation to the content on the app, and discuss what colorectal cancer is, and the type of CRC screening tests that are available as well as a video with a personal history. There is a a National Cancer Institute (NCI) risk calculation tool, and a family history infographic. Once the videos have been viewed participants have the option to indicate if they wish to receive a call from the healthcare clinic to discuss scheduling an appointment for screening. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 10 |
Baseline characteristics
| Characteristic | Tailored Screen to Save (S2S) Content |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 30 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 30 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Colorectal Screening Status
The number of participants that complete screening (any type)
Time frame: 3 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tailored Screen to Save (S2S) Content | Colorectal Screening Status | 6 Participants |
Secondary
Determine Feasibility of Mobile Health (mHealth) Application -Enrollment
The number of men that enroll for the intervention (application)
Time frame: Week 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tailored Screen to Save (S2S) Content | Determine Feasibility of Mobile Health (mHealth) Application -Enrollment | 30 Participants |
Secondary
Determine the Feasibility of the mHealth Application- Clinic/ Screening Request
The number of participants that respond to the request to contact clinic/ navigation services
Time frame: Week 12
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tailored Screen to Save (S2S) Content | Determine the Feasibility of the mHealth Application- Clinic/ Screening Request | Responded Yes for contact | 7 Participants |
| Tailored Screen to Save (S2S) Content | Determine the Feasibility of the mHealth Application- Clinic/ Screening Request | Responded No for contact | 21 Participants |
| Tailored Screen to Save (S2S) Content | Determine the Feasibility of the mHealth Application- Clinic/ Screening Request | Did not Respond | 2 Participants |
Secondary
Determine the Feasibility of the mHealth Application- Retention
The number of participants that complete Questionnaires (\>65%)
Time frame: Baseline (Day 1), Week 2, and Week 12
Population: Number of participants that completed questionnaires during specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tailored Screen to Save (S2S) Content | Determine the Feasibility of the mHealth Application- Retention | Baseline Questionnaires | 28 participants |
| Tailored Screen to Save (S2S) Content | Determine the Feasibility of the mHealth Application- Retention | Week 2 Questionnaires | 10 participants |
| Tailored Screen to Save (S2S) Content | Determine the Feasibility of the mHealth Application- Retention | Week 12 Questionnaires | 20 participants |
Secondary
Determine the Feasibility of the mHealth Application - Sharing Content
The number of participants that share content on social network
Time frame: Week 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tailored Screen to Save (S2S) Content | Determine the Feasibility of the mHealth Application - Sharing Content | 7 Participants |
Secondary
Determine the Feasibility of the mHealth Application-Videos
The number of participants that view the videos
Time frame: Week 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tailored Screen to Save (S2S) Content | Determine the Feasibility of the mHealth Application-Videos | 17 Participants |