Colorectal CancerNCT02100254
Narrative or Fact-Based Videos in Increasing Colorectal Cancer Screenings in African American Communities
A study testing behavioral intervention in people with Colorectal Cancer and Healthy, no Evidence of Disease, run by Roswell Park Cancer Institute at 2 sites in United States.
Trial summary
This randomized clinical trial studies narrative or fact-based videos in increasing colorectal cancer screenings in African American communities. Informational videotapes may help increase the number of participants who engage in colonoscopy screenings. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Healthy, no Evidence of Disease
- What is being tested?
- behavioral intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,310 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2009to 23 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants in each component (focus groups, surveys and educational programs) will be 18 years of age and over; these men and women are generally healthy, ambulatory and able to participate in events in their community; no women, men, or children of any ethnic or social background will be excluded from the educational program
- EDUCATIONAL INTERVENTION:
- Currently non-adherent to colorectal cancer screening
- Self-identify as African American
- Are 50 years of age or older
- Have the ability to provide informed consent in English
Show all 10Show fewer
- FOLLOW-UP ASSESSMENTS:
- Must be non-adherent for CRC screening at the time of the educational program
- Have telephone service (mobile or landline), to participate in the follow up interviews
- Agree to providing consent for release/review of their medical record
Who cannot join
- Non-English speaking
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
Mount Sinai School of Medicine
New York, New York, 10029
About this study
Official title: CRC Screening Thoughts and Feelings: Increasing Engagement of African Americans
This randomized clinical trial studies narrative or fact-based videos in increasing colorectal cancer screenings in African American communities. Informational videotapes may help increase the number of participants who engage in colonoscopy screenings. It is not yet known whether narrative videos may be more effective than fact-based videos in increasing colorectal cancer screenings.
Read the detailed description
PRIMARY OBJECTIVES:
- Assess both individual and environmental factors that guide decisions and behaviors to engage or not engage in colonoscopy screenings for African Americans in the two communities.
II. Using a Community-Based Participatory Research (CBPR) approach, develop and pilot a peer-led, narrative-based colorectal cancer behavioral intervention for increasing colonoscopy screening behaviors in African Americans.
III. Examine the efficacy of a narrative communication-style group intervention compared to a didactic intervention to influence African Americans' engagement in colorectal cancer screening, including examining the degree to which the community interventions impact cognitive and affective decision making factors about health care seeking.
IV. Examine and explore contextual factors that may influence the process of behavior change to better understand colorectal cancer (CRC) screening and health care seeking behaviors.
OUTLINE: Program locations are randomized to 1 of 2 arms.
ARM I: Participants view videos with information about CRC and screening delivered by personal narrative.
ARM II: Participants view videos with information about CRC and screening delivered by informative fact-based message.
After completion of study, patients are followed up at 3 and 6 months.
- Conditions
- Colorectal Cancer, Healthy, no Evidence of Disease
- Being tested
- behavioral intervention
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral interventionBehavioural
Also called Behavior Conditioning Therapy, Behavior Therapy, Behavioral Modification, Behavioral Therapy
View personal narrative informational video
behavioral interventionBehavioural
Also called Behavior Conditioning Therapy, Behavior Therapy, Behavioral Modification, Behavioral Therapy
View fact-based informational video
| Study group | Role | What they receive |
|---|---|---|
| Arm I (personal narrative) | Experimental | Participants view videos with information about CRC and screening delivered by personal narrative. Receives: Behavioral: behavioral intervention |
| Arm II (fact-based message) | Active comparator | Participants view videos with information about CRC and screening delivered by informative fact-based message. Receives: Behavioral: behavioral intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in likelihood of CRC screening in previously unscreened subjects
A change score (post-presentation minus pre-presentation) will be created and summarized. In addition, the change score will be further dichotomized (e.g. increase versus no increase in the likelihood of screening) and the percent of those who experienced an increased likelihood, denoted by pi, will be computed. A corresponding 95% confidence interval will be calculated. To test for differences in variables collected pre- and post-presentation, generalized mixed linear models will be used. Testing will be done at the 0.0.5 nominal significance level and using the approximate t-test method.
Measured: Baseline to 6 months post-presentation
Secondary outcomes (7)
Number of negative affective responses to CRC screening per Affective Associations and Affectively-Based Risk surveys
A linear mixed model (LMM) will be employed and implemented in the SAS program MIXED.
Measured: Post-presentation up to 6 months
Number of positive cognitive responses to CRC screening per Cognitively-Based Perceived Risk survey
An LMM will be employed and implemented in the SAS program MIXED.
Measured: Post-presentation up to 6 months
Number of participants who had or scheduled colonoscopy
A generalized linear model with a logit link function will be used.
Measured: Up to 6 months
Number of participants who performed the fecal occult blood test (FOBT)/fecal immunohistochemistry test (FIT)
A generalized linear model with a logit link function will be used.
Measured: Up to 6 months
Number of participants who discussed CRC screening with their primary care physician
A generalized linear model with a logit link function will be used.
Measured: Up to 6 months
Influential factors in behavior changes, assessed using qualitative analyses of text from participant interviews, including affective associations with the program, participants' cognitive-affective influences, and predisposing influences
Qualitative text from a text analysis program will be funneled into categories using the PEN-3 and analyzed according to the categories' role and influence. Findings will be examined in comparison to quantitative data regarding the content of the intervention.
Measured: Baseline to 1 week post-presentation & 6-months
Influential factors in behavior changes, assessed using qualitative analyses of text from participant interviews, including affective associations with the program, participants' cognitive-affective influences, and predisposing influences
Qualitative text from a text analysis program will be funneled into categories using the PEN-3 and analyzed according to the categories' role and influence. Findings will be examined in comparison to quantitative data regarding the content of the intervention.
Measured: 1 week post-presentation to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study start1 Oct 2009
- Primary completion23 Sep 2016
- Study completion23 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deborah Erwin, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100254
- Sponsor's protocol ID
- I 159309
- Other IDs
- NCI-2013-01707, I 159309
- Status last verified
- Jul 2022
- First submitted
- 12 Mar 2014
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Kiviniemi MT, Klasko-Foster LB, Erwin DO, Jandorf L. Decision-making and socioeconomic disparities in colonoscopy screening in African Americans. Health Psychol. 2018 May;37(5):481-490. doi: 10.1037/hea0000603. Epub 2018 Mar 29.
PubMed 29595298
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRC Screening Thoughts and Feelings: Increasing Engagement of African Americans
- ClinicalTrials.gov ID
- NCT02100254
- Acronym / sponsor ID
- I 159309
- Conditions
- Colorectal Cancer, Healthy, no Evidence of Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,310 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 1 Oct 2009
- Primary completion
- 23 Sep 2016 (actual)
- Study completion
- 23 Sep 2017 (actual)
- First posted
- 31 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized clinical trial studies narrative or fact-based videos in increasing colorectal cancer screenings in African American communities. Informational videotapes may help increase the number of participants who engage in colonoscopy screenings. It is not yet known whether narrative videos may be more effective than fact-based videos in increasing colorectal cancer screenings.
Detailed description
PRIMARY OBJECTIVES:
- Assess both individual and environmental factors that guide decisions and behaviors to engage or not engage in colonoscopy screenings for African Americans in the two communities.
II. Using a Community-Based Participatory Research (CBPR) approach, develop and pilot a peer-led, narrative-based colorectal cancer behavioral intervention for increasing colonoscopy screening behaviors in African Americans.
III. Examine the efficacy of a narrative communication-style group intervention compared to a didactic intervention to influence African Americans' engagement in colorectal cancer screening, including examining the degree to which the community interventions impact cognitive and affective decision making factors about health care seeking.
IV. Examine and explore contextual factors that may influence the process of behavior change to better understand colorectal cancer (CRC) screening and health care seeking behaviors.
OUTLINE: Program locations are randomized to 1 of 2 arms.
ARM I: Participants view videos with information about CRC and screening delivered by personal narrative.
ARM II: Participants view videos with information about CRC and screening delivered by informative fact-based message.
After completion of study, patients are followed up at 3 and 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (personal narrative) | Experimental | Behavioral: behavioral interventionParticipants view videos with information about CRC and screening delivered by personal narrative. |
| Arm II (fact-based message) | Active comparator | Behavioral: behavioral interventionParticipants view videos with information about CRC and screening delivered by informative fact-based message. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants in each component (focus groups, surveys and educational programs) will be 18 years of age and over; these men and women are generally healthy, ambulatory and able to participate in events in their community; no women, men, or children of any ethnic or social background will be excluded from the educational program
- EDUCATIONAL INTERVENTION:
- Currently non-adherent to colorectal cancer screening
- Self-identify as African American
- Are 50 years of age or older
Key exclusion criteria (1 listed)
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behavioral interventionAlso: Behavior Conditioning Therapy, Behavior Therapy, Behavioral Modification, Behavioral TherapyView personal narrative informational video | Behavioural | Arm I (personal narrative) |
| behavioral interventionAlso: Behavior Conditioning Therapy, Behavior Therapy, Behavioral Modification, Behavioral TherapyView fact-based informational video | Behavioural | Arm II (fact-based message) |
Primary outcome
Change in likelihood of CRC screening in previously unscreened subjects
Time frame: Baseline to 6 months post-presentation
A change score (post-presentation minus pre-presentation) will be created and summarized. In addition, the change score will be further dichotomized (e.g. increase versus no increase in the likelihood of screening) and the percent of those who experienced an increased likelihood, denoted by pi, will be computed. A corresponding 95% confidence interval will be calculated. To test for differences in variables collected pre- and post-presentation, generalized mixed linear models will be used. Testing will be done at the 0.0.5 nominal significance level and using the approximate t-test method.
7 secondary outcomes
Number of negative affective responses to CRC screening per Affective Associations and Affectively-Based Risk surveys
Time frame: Post-presentation up to 6 months
Number of positive cognitive responses to CRC screening per Cognitively-Based Perceived Risk survey
Time frame: Post-presentation up to 6 months
Number of participants who had or scheduled colonoscopy
Time frame: Up to 6 months
Number of participants who performed the fecal occult blood test (FOBT)/fecal immunohistochemistry test (FIT)
Time frame: Up to 6 months
Number of participants who discussed CRC screening with their primary care physician
Time frame: Up to 6 months
Influential factors in behavior changes, assessed using qualitative analyses of text from participant interviews, including affective associations with the program, participants' cognitive-affective influences, and predisposing influences
Time frame: Baseline to 1 week post-presentation & 6-months
Influential factors in behavior changes, assessed using qualitative analyses of text from participant interviews, including affective associations with the program, participants' cognitive-affective influences, and predisposing influences
Time frame: 1 week post-presentation to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Derived from this study: PubMed 29595298Kiviniemi MT, Klasko-Foster LB, Erwin DO, Jandorf L. Decision-making and socioeconomic disparities in colonoscopy screening in African Americans. Health Psychol. 2018 May;37(5):481-490. doi: 10.1037/hea0000603. Epub 2018 Mar 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Erwin principal investigator
Roswell Park Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behavioral intervention in people with Colorectal Cancer and Healthy, no Evidence of Disease, run by Roswell Park Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in likelihood of CRC screening in previously unscreened subjects (time frame: Baseline to 6 months post-presentation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02100254, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.