Colorectal CancerNCT03078361
Latinos CARES (Colorectal Cancer Awareness, Research, Education and Screening)
A study testing Immunochemical Fecal Occult Blood Test (I-FOBT) Kit, LATINOS CARES Toolkit and Standard Intervention 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 study is to conduct 4 focus groups and recruit for 12 participants per focus group to explore community members' views about colorectal cancer screening (CRCS) processes and perceived benefits and impediments, what information they believe should be communicated, communication preferences (style… Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Colorectal Carcinoma
- What is being tested?
- Immunochemical Fecal Occult Blood Test (I-FOBT) Kit, LATINOS CARES Toolkit and Standard Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2014to 26 Oct 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women, age 50-75 years
- Self-identify as Hispanic/Latino
- Able to understand, read, and speak Spanish
- Prefer to receive health information in Spanish
- Previously screened or not screened
Who cannot join
None listed.
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
Official title: Latinos CARES (Colorectal Cancer Awareness, Research, Education and Screening) Project
The purpose of this study is to conduct 4 focus groups and recruit for 12 participants per focus group to explore community members' views about colorectal cancer screening (CRCS) processes and perceived benefits and impediments, what information they believe should be communicated, communication preferences (style, tone) and perceptions of screenings.
- Conditions
- Colorectal Cancer, Colorectal Carcinoma
- Being tested
- Immunochemical Fecal Occult Blood Test (I-FOBT) Kit, LATINOS CARES Toolkit, Standard Intervention
- Keywords
- cancer screening, colon
- Medical subject headings
- Colorectal 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
Both intervention groups will receive an I-FOBT kit (by study coordinator) with verbal and written instructions in Spanish on how to complete the stool sampling at home within 1 week, and mail the completed kit in the pre-addressed, postage paid mailer. Patients with abnormal results will receive a call explaining the meaning of an abnormal I-FOBT and encouraging them to take specific next steps.
LATINOS CARES ToolkitBehavioural
DVD + photonovella booklet), about colorectal cancer screening (CRCS) targeted for a Latino medically underserved population.
Standard InterventionBehavioural
Standard intervention (CDC brochure) on colorectal cancer screening in community health clinics.
| Study group | Role | What they receive |
|---|---|---|
| LATINOS CARES Toolkit | Active comparator | Participants assigned to the LATINOS CARES condition will receive an I-FOBT kit, DVD and photonovella booklet from the study coordinator. The participant will view the DVD in a private area (headphones are available) using a portable DVD player in clinic before seeing the provider. The DVD will be about 8-10 minutes long. The participant will take the LATINOS CARES toolkit and I-FOBT home after the clinic visit. The participant will be instructed to re-review the materials and complete the I-FOBT stool sampling at home. Receives: Other: Immunochemical Fecal Occult Blood Test (I-FOBT) Kit; Behavioral: LATINOS CARES Toolkit |
| Standard Intervention (SI) | Active comparator | Participants assigned to the standard brochure (SI) will be provided a packet containing the CDC Spanish-language tri-fold brochure titled Screen for Life and an I-FOBT card. The participant will be instructed to review the materials in clinic and complete the I-FOBT stool sampling at home. This brochure describes CRC, risk factors, symptoms, screening tests, benefits of screening, and insurance coverage. Receives: Other: Immunochemical Fecal Occult Blood Test (I-FOBT) Kit; Behavioral: Standard Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Feedback from Community Advisory Board
Successful collection of feedback to complete production of Spanish-language LATINOS CARES Intervention.
This aim involves no statistical analysis except the summary statistics for the participants. To adapt (transcreate) and produce an educational intervention entitled LATINOS CARES (DVD + photonovella booklet), about colorectal cancer screening (CRCS) targeted for a Latino medically underserved population. BENCHMARK: Production of Spanish-language LATINOS CARES intervention that is easy-to understand, salient, and culturally suitable.
Measured: Up to 4 months
Secondary outcomes (2)
Rate of Receipt of I-FOBT from Participants
BENCHMARK: Receipt of Immunochemical Fecal Occult Blood Test (I-FOBT home kit).
Measured: Up to 4 months
Rate of Receipt of Assessments from Participants
BENCHMARK: Receipt of Assessments.
Measured: Up to 4 months
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 start28 Apr 2014
- Primary completion14 Jul 2016
- Study completion26 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 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
- Model description
- After completion of baseline assessments, participants will be randomized so that the study personnel are unaware of the intervention assignment at the time of the baseline assessment.
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Department of Health, Bankhead-Coley Cancer Research Program
- 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
- NCT03078361
- Sponsor's protocol ID
- MCC-17665
- Status last verified
- Aug 2022
- First submitted
- 3 Mar 2017
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chavarria EA, Christy SM, Feng H, Miao H, Abdulla R, Gutierrez L, Lopez D, Sanchez J, Gwede CK, Meade CD. Online Health Information Seeking and eHealth Literacy Among Spanish Language-Dominant Latino Adults Receiving Care in a Community Clinic: Secondary Analysis of Pilot Randomized Controlled Trial Data. JMIR Form Res. 2022 Oct 13;6(10):e37687. doi: 10.2196/37687.
PubMed 35238785Christy SM, Cousin LA, Sutton SK, Chavarria EA, Abdulla R, Gutierrez L, Sanchez J, Lopez D, Gwede CK, Meade CD. Characterizing Health Literacy Among Spanish Language-Preferring Latinos Ages 50-75. Nurs Res. 2021 Set/Oct 01;70(5):344-353. doi: 10.1097/NNR.0000000000000519.
PubMed 33990120
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Latinos CARES (Colorectal Cancer Awareness, Research, Education and Screening) Project
- ClinicalTrials.gov ID
- NCT03078361
- Acronym / sponsor ID
- MCC-17665
- Conditions
- Colorectal Cancer, Colorectal Carcinoma
- Keywords
- cancer screening, colon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Florida Department of Health, Bankhead-Coley Cancer Research Program
- Study start
- 28 Apr 2014 (actual)
- Primary completion
- 14 Jul 2016 (actual)
- Study completion
- 26 Oct 2022 (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 study is to conduct 4 focus groups and recruit for 12 participants per focus group to explore community members' views about colorectal cancer screening (CRCS) processes and perceived benefits and impediments, what information they believe should be communicated, communication preferences (style, tone) and perceptions of screenings.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After completion of baseline assessments, participants will be randomized so that the study personnel are unaware of the intervention assignment at the time of the baseline assessment.
| Arm | Type | Receives |
|---|---|---|
| LATINOS CARES Toolkit | Active comparator | Other: Immunochemical Fecal Occult Blood Test (I-FOBT) Kit, Behavioral: LATINOS CARES ToolkitParticipants assigned to the LATINOS CARES condition will receive an I-FOBT kit, DVD and photonovella booklet from the study coordinator. The participant will view the DVD in a private area (headphones are available) using a portable DVD player in clinic before seeing the provider. The DVD will be about 8-10 minutes long. The participant will take the LATINOS CARES toolkit and I-FOBT home after the clinic visit. The participant will be instructed to re-review the materials and complete the I-FOBT stool sampling at home. |
| Standard Intervention (SI) | Active comparator | Other: Immunochemical Fecal Occult Blood Test (I-FOBT) Kit, Behavioral: Standard InterventionParticipants assigned to the standard brochure (SI) will be provided a packet containing the CDC Spanish-language tri-fold brochure titled Screen for Life and an I-FOBT card. The participant will be instructed to review the materials in clinic and complete the I-FOBT stool sampling at home. This brochure describes CRC, risk factors, symptoms, screening tests, benefits of screening, and insurance coverage. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women, age 50-75 years
- Self-identify as Hispanic/Latino
- Able to understand, read, and speak Spanish
- Prefer to receive health information in Spanish
- Previously screened or not screened
Key exclusion criteria (0 listed)
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) KitBoth intervention groups will receive an I-FOBT kit (by study coordinator) with verbal and written instructions in Spanish on how to complete the stool sampling at home within 1 week, and mail the completed kit in the pre-addressed, postage paid mailer. Patients with abnormal results will receive a call explaining the meaning of an abnormal I-FOBT and encouraging them to take specific next steps. | Other | LATINOS CARES Toolkit, Standard Intervention (SI) |
| LATINOS CARES ToolkitDVD + photonovella booklet), about colorectal cancer screening (CRCS) targeted for a Latino medically underserved population. | Behavioural | LATINOS CARES Toolkit |
| Standard InterventionStandard intervention (CDC brochure) on colorectal cancer screening in community health clinics. | Behavioural | Standard Intervention (SI) |
Primary outcome
Rate of Feedback from Community Advisory Board
Time frame: Up to 4 months
Successful collection of feedback to complete production of Spanish-language LATINOS CARES Intervention. This aim involves no statistical analysis except the summary statistics for the participants. To adapt (transcreate) and produce an educational intervention entitled LATINOS CARES (DVD + photonovella booklet), about colorectal cancer screening (CRCS) targeted for a Latino medically underserved population. BENCHMARK: Production of Spanish-language LATINOS CARES intervention that is easy-to understand, salient, and culturally suitable.
2 secondary outcomes
Rate of Receipt of I-FOBT from Participants
Time frame: Up to 4 months
Rate of Receipt of Assessments from Participants
Time frame: Up to 4 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 11 Jan 2023.
- Derived from this study: PubMed 35238785Chavarria EA, Christy SM, Feng H, Miao H, Abdulla R, Gutierrez L, Lopez D, Sanchez J, Gwede CK, Meade CD. Online Health Information Seeking and eHealth Literacy Among Spanish Language-Dominant Latino Adults Receiving Care in a Community Clinic: Secondary Analysis of Pilot Randomized Controlled Trial Data. JMIR Form Res. 2022 Oct 13;6(10):e37687. doi: 10.2196/37687.
- Derived from this study: PubMed 33990120Christy SM, Cousin LA, Sutton SK, Chavarria EA, Abdulla R, Gutierrez L, Sanchez J, Lopez D, Gwede CK, Meade CD. Characterizing Health Literacy Among Spanish Language-Preferring Latinos Ages 50-75. Nurs Res. 2021 Set/Oct 01;70(5):344-353. doi: 10.1097/NNR.0000000000000519.
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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 Immunochemical Fecal Occult Blood Test (I-FOBT) Kit, LATINOS CARES Toolkit and Standard Intervention 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 5 inclusion and 0 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 11 Jan 2023. 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 Feedback from Community Advisory Board (time frame: Up to 4 months). 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 NCT03078361, which also lists 2 linked publications.
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 11 Jan 2023.