Colorectal CancerIACCTNCT03078348
Increasing Access to Colorectal Cancer Testing (IACCT) for Blacks
A study testing Fecal Immunochemical Test (FIT) Kit, Culturally targeted Photo Novella Booklet and Screen for Life Brochure in people with Colorectal Cancer and Colorectal Carcinoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this research study is to compare a new educational material to another widely available educational brochure. The goal is to see if the new educational material will change knowledge and behaviors about colorectal cancer and colorectal screening. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Colorectal Carcinoma
- What is being tested?
- Fecal Immunochemical Test (FIT) Kit, Culturally targeted Photo Novella Booklet and Screen for Life Brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 331 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2011to 3 May 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Community-based recruitment methods will be used including promotional flyers and word of mouth at locations such as churches, barber shops, civic/community social service centers, senior centers, cultural groups. The flyers will provide brief information and advertise a telephone number for potential participants to call the study office at Moffitt.
- Self identify as Black or African American
- Have no symptoms of colorectal cancer (CRC), or personal diagnosis of CRC or bowel inflammatory disease or related syndromes
- Have not had recent CRC screening per guidelines (never screened or overdue)
- Participants must provide at least two forms of contact information (mailing address, home telephone or cell phone or email address), and contact information of a secondary individual who has a number that is different from the participant (this person may be a relative or friend living with the respondent).
- Spouse or relatives of respondent are potentially eligible.
Who cannot join
- Individuals who have participated in a colorectal cancer screening (CRCS) research in the past 1 year will not be eligible for this study.
- Additional criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
The purpose of this research study is to compare a new educational material to another widely available educational brochure. The goal is to see if the new educational material will change knowledge and behaviors about colorectal cancer and colorectal screening.
- Conditions
- Colorectal Cancer, Colorectal Carcinoma
- Being tested
- Fecal Immunochemical Test (FIT) Kit, Culturally targeted Photo Novella Booklet, Screen for Life Brochure
- Keywords
- cancer screening
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Immunochemical Test (FIT) KitOther
Free FIT Kits distributed at study entry.
Culturally targeted Photo Novella BookletBehavioural
Culturally targeted Photo Novella Booklet + culturally targeted reminders. Print materials developed by the Centers for Disease Control and Prevention (CDC)) to provide information about CRC, importance of screening and available screening tests. Timed reminder letters and/or emails intended as a cue to action and as educational boost to facilitate participant screening decision making and screening uptake.
Screen for Life BrochureBehavioural
Screen for Life Brochure + standard reminders. Print materials developed by the Centers for Disease Control and Prevention (CDC)) to provide information about CRC, importance of screening and available screening tests. Timed reminder letters and/or emails intended as a cue to action and as educational boost to facilitate participant screening decision making and screening uptake.
| Study group | Role | What they receive |
|---|---|---|
| Targeted Psychoeducational Photo Novella | Active comparator | Fecal Immunochemical Test (FIT) Kit + Culturally targeted Photo Novella Booklet + culturally targeted reminders. This study involves participation at distinct time points:
1. Baseline
2. 6 month follow-up Receives: Other: Fecal Immunochemical Test (FIT) Kit; Behavioral: Culturally targeted Photo Novella Booklet |
| Standard Brochure Intervention | Active comparator | FIT Kit + Screen for Life Brochure + standard reminders. This study involves participation at distinct time points:
1. Baseline
2. Post 6 month follow-up Receives: Other: Fecal Immunochemical Test (FIT) Kit; Behavioral: Screen for Life Brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Fecal Immunochemical Test (FIT) Kit Return Per Study Arm
Fit screening uptake at 6 months. Number of participants who used and returned their FIT Kit, per study arm. A FIT Kit was provided to participants in both study arms for use and return.
Measured: 6 months post final enrollment
Secondary outcomes (1)
Rate of Diagnostic Colonoscopy
Number of participants who participated in a diagnostic colonoscopy, post test kit return.
Measured: Post 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start5 Dec 2011
- Primary completion23 Oct 2015
- Study completion3 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this modified "block" random assignment, all individuals recruited from the same geographic unit will receive the intervention assigned to that area in order to reduce intervention contamination. Individuals will not be made aware of their randomization (intervention) condition until after baseline assessment. The research assistants will also be assigned at random to work with one geographic area (i.e., one intervention condition) in order to reduce risk of intervention contamination by study staff.
- Masking
- None (open label)
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Clement Gwede, Ph.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078348
- Sponsor's protocol ID
- MCC-16501
- Acronym
- IACCT
- Status last verified
- Nov 2022
- First submitted
- 3 Mar 2017
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Access to Colorectal Cancer Testing (IACCT) for Blacks
- ClinicalTrials.gov ID
- NCT03078348
- Acronym / sponsor ID
- IACCT / MCC-16501
- Conditions
- Colorectal Cancer, Colorectal Carcinoma
- Keywords
- cancer screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 5 Dec 2011 (actual)
- Primary completion
- 23 Oct 2015 (actual)
- Study completion
- 3 May 2017 (actual)
- First posted
- 13 Mar 2017 (actual)
- 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.
The purpose of this research study is to compare a new educational material to another widely available educational brochure. The goal is to see if the new educational material will change knowledge and behaviors about colorectal cancer and colorectal screening.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this modified "block" random assignment, all individuals recruited from the same geographic unit will receive the intervention assigned to that area in order to reduce intervention contamination. Individuals will not be made aware of their randomization (intervention) condition until after baseline assessment. The research assistants will also be assigned at random to work with one geographic area (i.e., one intervention condition) in order to reduce risk of intervention contamination by study staff.
| Arm | Type | Receives |
|---|---|---|
| Targeted Psychoeducational Photo Novella | Active comparator | Other: Fecal Immunochemical Test (FIT) Kit, Behavioral: Culturally targeted Photo Novella BookletFecal Immunochemical Test (FIT) Kit + Culturally targeted Photo Novella Booklet + culturally targeted reminders. This study involves participation at distinct time points: 1. Baseline 2. 6 month follow-up |
| Standard Brochure Intervention | Active comparator | Other: Fecal Immunochemical Test (FIT) Kit, Behavioral: Screen for Life BrochureFIT Kit + Screen for Life Brochure + standard reminders. This study involves participation at distinct time points: 1. Baseline 2. Post 6 month follow-up |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Community-based recruitment methods will be used including promotional flyers and word of mouth at locations such as churches, barber shops, civic/community social service centers, senior centers, cultural groups. The flyers will provide brief information and advertise a telephone number for potential participants to call the study office at Moffitt.
- Self identify as Black or African American
- Have no symptoms of colorectal cancer (CRC), or personal diagnosis of CRC or bowel inflammatory disease or related syndromes
- Have not had recent CRC screening per guidelines (never screened or overdue)
- Participants must provide at least two forms of contact information (mailing address, home telephone or cell phone or email address), and contact information of a secondary individual who has a number that is different from the participant (this person may be a relative or friend living with the respondent).
Key exclusion criteria (2 listed)
- Individuals who have participated in a colorectal cancer screening (CRCS) research in the past 1 year will not be eligible for this study.
- Additional criteria may apply.
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 |
|---|---|---|
| Fecal Immunochemical Test (FIT) KitFree FIT Kits distributed at study entry. | Other | Standard Brochure Intervention, Targeted Psychoeducational Photo Novella |
| Culturally targeted Photo Novella BookletCulturally targeted Photo Novella Booklet + culturally targeted reminders. Print materials developed by the Centers for Disease Control and Prevention (CDC)) to provide information about CRC, importance of screening and available screening tests. Timed reminder letters and/or emails intended as a cue to action and as educational boost to facilitate participant screening decision making and screening uptake. | Behavioural | Targeted Psychoeducational Photo Novella |
| Screen for Life BrochureScreen for Life Brochure + standard reminders. Print materials developed by the Centers for Disease Control and Prevention (CDC)) to provide information about CRC, importance of screening and available screening tests. Timed reminder letters and/or emails intended as a cue to action and as educational boost to facilitate participant screening decision making and screening uptake. | Behavioural | Standard Brochure Intervention |
Primary outcome
Rate of Fecal Immunochemical Test (FIT) Kit Return Per Study Arm
Time frame: 6 months post final enrollment
Fit screening uptake at 6 months. Number of participants who used and returned their FIT Kit, per study arm. A FIT Kit was provided to participants in both study arms for use and return.
1 secondary outcome
Rate of Diagnostic Colonoscopy
Time frame: Post 6 month follow-up
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 9 Nov 2022.
- Moffitt Cancer Center Clinical Trials websiteLink provided by the sponsor.
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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.
Clement Gwede, Ph.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Immunochemical Test (FIT) Kit, Culturally targeted Photo Novella Booklet and Screen for Life Brochure in people with Colorectal Cancer and Colorectal Carcinoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site 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 6 inclusion and 2 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 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Rate of Fecal Immunochemical Test (FIT) Kit Return Per Study Arm (time frame: 6 months post final enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2022.