Colorectal CancerNCT01804179
Colorectal Cancer Awareness, Research, Education and Screening (CARES)
A study testing Immunochemical Fecal Occult Blood Test (I-FOBT) Kit, Standard Intervention (SI) Educational Materials and CARES Intervention Educational Materials in people with Colorectal Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
There are two parts to this study: (1) an information gathering phase leading to the development of new educational materials; and (2) a study to test the newly developed material. The information gathering phase has been completed. 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
- What is being tested?
- Immunochemical Fecal Occult Blood Test (I-FOBT) Kit, Standard Intervention (SI) Educational Materials and CARES Intervention Educational Materials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 514 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2011to 9 Sep 2022
- 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
- Racially-ethnically diverse adult men and women
- Average risk individuals who have no personal diagnosis, or presumptive symptoms of colorectal cancer (CRC), or are not at high risk
- Self-report as not current on screening
- Provide at least two forms of contact information and contact information of a relative (not living with respondent) to facilitate follow-up contacts
- Are able to speak, read and write English because the instruments and CARES intervention are available only in English at this time. We recognize that interventions are needed for non-English speaking populations, therefore, once we find promise in the English language CARES intervention materials, we will move forward with conducting other studies that involve translation of measures and cultural adaptation of the CARES intervention materials into Spanish or Haitian Creole.
Who cannot join
- Individuals who have participated in a CRCS research study in the past 1 year will not be eligible for this study.
- Recent screening criteria relates to not having had I-FOBT within the previous year, flex sig within the previous 5 years, a double-contrast barium enema (DCBE) x-ray with the previous 5 years, or a colonoscopy within the previous 10 years.
- Within the recruitment and intervention frame, high risk individuals (due to strong family history, ulcerative colitis, polyposis syndromes) are excluded because they may be eligible for CRC screening before age 50, and the preferred screening option is certainly colonoscopy which is beyond the primary focus of the current study.
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
There are two parts to this study: (1) an information gathering phase leading to the development of new educational materials; and (2) a study to test the newly developed material. The information gathering phase has been completed. The purpose of this part of the research study is to test the usefulness and acceptability of new educational materials investigators have developed. Investigators will compare the 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 the detailed description
Federally qualified health centers (FQHCs) and other community health clinics (CHCs) provide comprehensive primary health care for underserved patients. Recently, high-sensitivity and high-specificity fecal occult blood tests (FOBT) and fecal immunochemical tests (FIT) have emerged as a preferred initial screening modality within clinics due to convenience, ease of use, and low cost compared with colonoscopy. FOBT/FIT may help to reduce colorectal cancer screening (CRC) screening disparities and overcome several previously mentioned factors that often account for suboptimal CRC screening rates.
- Conditions
- Colorectal Cancer
- Being tested
- Immunochemical Fecal Occult Blood Test (I-FOBT) Kit, Standard Intervention (SI) Educational Materials, CARES Intervention Educational Materials, Baseline Visit Survey, Follow-up Questionnaire
- Keywords
- colon, rectum, cancer, screening, questionnaire, testing, educational materials
- Medical subject headings
- Colorectal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunochemical Fecal Occult Blood Test (I-FOBT) KitOther
Also called Home Stool Blood Test, fecal immunochemical test (FIT)
Participants will receive an Immunochemical Fecal Occult Blood Test (I-FOBT) Kit (a home stool blood test) used as a first-step screening tool for colorectal cancer to take home. The research staff will provide instructions on how to use the kit.
Standard Intervention (SI) Educational MaterialsOther
"Screen for Life" brochure
CARES Intervention Educational MaterialsOther
Newly developed digital video disc (DVD) and booklet
Baseline Visit SurveyOther
In both conditions, patients will participate in a Baseline Survey. Three brief items will be used to assess patient-provider discussion and recommendation: (1) Was colorectal cancer or colorectal cancer screening one of the things you discussed with the doctor or health care provider? (Yes/No). (2) If Yes, who brought the topic of colorectal cancer first? (patient/health care provider). (3) Did your doctor or health care provider recommend colorectal cancer screening? (Yes/No). These questions are necessary to evaluate the impact of interventions on patient-provider discussion of CRCS and provider recommendation of CRCS.
Follow-up QuestionnaireOther
12 months after participants began to participate in the study, they will be contacted via telephone to complete a final set of questionnaires. Participants will be asked questions similar to those answered in baseline. This time they will ask about the participant's thoughts on the educational materials as well.
| Study group | Role | What they receive |
|---|---|---|
| Standard Intervention (SI) | Active comparator | At Baseline Visit, Participants in the standard intervention (SI) condition will get: I-FOBT kit and "Screen for Life" brochure, a mailed reminder card at two weeks post-intervention to remind them about FOBT testing and follow up assessments at 12 months. Receives: Other: Immunochemical Fecal Occult Blood Test (I-FOBT) Kit; Other: Standard Intervention (SI) Educational Materials; Other: Baseline Visit Survey; Other: Follow-up Questionnaire |
| CARES Intervention | Experimental | Colorectal Cancer Awareness, Research, Education and Screening (CARES). At Baseline Visit, Participants in the CARES intervention will receive: I-FOBT kit, a newly developed DVD and booklet, and a mailed reminder card at two weeks post-intervention to remind them about FOBT testing, and follow-up assessments at 12 months. Receives: Other: Immunochemical Fecal Occult Blood Test (I-FOBT) Kit; Other: CARES Intervention Educational Materials; Other: Baseline Visit Survey; Other: Follow-up Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Test Kit Completion
Investigators will measure uptake of I-FOBT/FIT as any completed kit within 180 days of delivery of the intervention. That is, the proportion of participants who return a sampled kit by the 6 month assessment (investigators expect most kits to be returned much sooner) for calculation of the primary screening endpoint. I-FOBT/FIT use will be compared (CARES vs. SI).
Measured: 6 months post final enrollment
Secondary outcomes (2)
Overall Colorectal Cancer Screening (CRCS) With Any Test
Overall CRCS with any test will be compared (CARES vs. SI). It is expected that pairing I-FOBT/FIT kits with the CARES toolkit will result in greater CRCS uptake compared to SI plus I-FOBT/FIT.
Measured: 12 months post final enrollment
Time to Kit Return
Maximum number of months required for kit return per study arm.
Measured: Up to 12 months post final enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study start11 Feb 2011
- Primary completion31 Jan 2015
- Study completion9 Sep 2022
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.
- More trials run by H. Lee Moffitt Cancer Center and Research 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 514 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clement Gwede, PhD, MPH, RN, Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804179
- Sponsor's protocol ID
- MCC-16447
- Status last verified
- Aug 2022
- First submitted
- 1 Mar 2013
- Last updated
- 10 Sep 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 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal Cancer Awareness, Research, Education and Screening (CARES)
- ClinicalTrials.gov ID
- NCT01804179
- Acronym / sponsor ID
- MCC-16447
- Conditions
- Colorectal Cancer
- Keywords
- colon, rectum, cancer, screening, questionnaire, testing, educational materials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 514 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 11 Feb 2011 (actual)
- Primary completion
- 31 Jan 2015 (actual)
- Study completion
- 9 Sep 2022 (actual)
- First posted
- 5 Mar 2013 (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.
There are two parts to this study: (1) an information gathering phase leading to the development of new educational materials; and (2) a study to test the newly developed material. The information gathering phase has been completed. The purpose of this part of the research study is to test the usefulness and acceptability of new educational materials investigators have developed. Investigators will compare the 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.
Detailed description
Federally qualified health centers (FQHCs) and other community health clinics (CHCs) provide comprehensive primary health care for underserved patients. Recently, high-sensitivity and high-specificity fecal occult blood tests (FOBT) and fecal immunochemical tests (FIT) have emerged as a preferred initial screening modality within clinics due to convenience, ease of use, and low cost compared with colonoscopy. FOBT/FIT may help to reduce colorectal cancer screening (CRC) screening disparities and overcome several previously mentioned factors that often account for suboptimal CRC screening rates.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Intervention (SI) | Active comparator | Other: Immunochemical Fecal Occult Blood Test (I-FOBT) Kit, Other: Standard Intervention (SI) Educational Materials, Other: Baseline Visit Survey, Other: Follow-up QuestionnaireAt Baseline Visit, Participants in the standard intervention (SI) condition will get: I-FOBT kit and "Screen for Life" brochure, a mailed reminder card at two weeks post-intervention to remind them about FOBT testing and follow up assessments at 12 months. |
| CARES Intervention | Experimental | Other: Immunochemical Fecal Occult Blood Test (I-FOBT) Kit, Other: CARES Intervention Educational Materials, Other: Baseline Visit Survey, Other: Follow-up QuestionnaireColorectal Cancer Awareness, Research, Education and Screening (CARES). At Baseline Visit, Participants in the CARES intervention will receive: I-FOBT kit, a newly developed DVD and booklet, and a mailed reminder card at two weeks post-intervention to remind them about FOBT testing, and follow-up assessments at 12 months. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Racially-ethnically diverse adult men and women
- Average risk individuals who have no personal diagnosis, or presumptive symptoms of colorectal cancer (CRC), or are not at high risk
- Self-report as not current on screening
- Provide at least two forms of contact information and contact information of a relative (not living with respondent) to facilitate follow-up contacts
- Are able to speak, read and write English because the instruments and CARES intervention are available only in English at this time. We recognize that interventions are needed for non-English speaking populations, therefore, once we find promise in the English language CARES intervention materials, we will move forward with conducting other studies that involve translation of measures and cultural adaptation of the CARES intervention materials into Spanish or Haitian Creole.
Key exclusion criteria (3 listed)
- Individuals who have participated in a CRCS research study in the past 1 year will not be eligible for this study.
- Recent screening criteria relates to not having had I-FOBT within the previous year, flex sig within the previous 5 years, a double-contrast barium enema (DCBE) x-ray with the previous 5 years, or a colonoscopy within the previous 10 years.
- Within the recruitment and intervention frame, high risk individuals (due to strong family history, ulcerative colitis, polyposis syndromes) are excluded because they may be eligible for CRC screening before age 50, and the preferred screening option is certainly colonoscopy which is beyond the primary focus of the current study.
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 |
|---|---|---|
| Immunochemical Fecal Occult Blood Test (I-FOBT) KitAlso: Home Stool Blood Test, fecal immunochemical test (FIT)Participants will receive an Immunochemical Fecal Occult Blood Test (I-FOBT) Kit (a home stool blood test) used as a first-step screening tool for colorectal cancer to take home. The research staff will provide instructions on how to use the kit. | Other | CARES Intervention, Standard Intervention (SI) |
| Standard Intervention (SI) Educational Materials"Screen for Life" brochure | Other | Standard Intervention (SI) |
| CARES Intervention Educational MaterialsNewly developed digital video disc (DVD) and booklet | Other | CARES Intervention |
| Baseline Visit SurveyIn both conditions, patients will participate in a Baseline Survey. Three brief items will be used to assess patient-provider discussion and recommendation: (1) Was colorectal cancer or colorectal cancer screening one of the things you discussed with the doctor or health care provider? (Yes/No). (2) If Yes, who brought the topic of colorectal cancer first? (patient/health care provider). (3) Did your doctor or health care provider recommend colorectal cancer screening? (Yes/No). These questions are necessary to evaluate the impact of interventions on patient-provider discussion of CRCS and provider recommendation of CRCS. | Other | CARES Intervention, Standard Intervention (SI) |
| Follow-up Questionnaire12 months after participants began to participate in the study, they will be contacted via telephone to complete a final set of questionnaires. Participants will be asked questions similar to those answered in baseline. This time they will ask about the participant's thoughts on the educational materials as well. | Other | CARES Intervention, Standard Intervention (SI) |
Primary outcome
Rate of Test Kit Completion
Time frame: 6 months post final enrollment
Investigators will measure uptake of I-FOBT/FIT as any completed kit within 180 days of delivery of the intervention. That is, the proportion of participants who return a sampled kit by the 6 month assessment (investigators expect most kits to be returned much sooner) for calculation of the primary screening endpoint. I-FOBT/FIT use will be compared (CARES vs. SI).
2 secondary outcomes
Overall Colorectal Cancer Screening (CRCS) With Any Test
Time frame: 12 months post final enrollment
Time to Kit Return
Time frame: Up to 12 months post final enrollment
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 10 Sep 2022.
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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, PhD, MPH, RN 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 Immunochemical Fecal Occult Blood Test (I-FOBT) Kit, Standard Intervention (SI) Educational Materials and CARES Intervention Educational Materials in people with Colorectal Cancer, 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 5 inclusion and 3 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 10 Sep 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 Test Kit Completion (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 10 Sep 2022.