Colorectal CancerSPLVNCT05502666
¡Salud! Por la Vida (SPLV) A Colorectal Screening Promotion Program
A study testing ¡Salud! Por la Vida in people with Colorectal Cancer, run by University of Puerto Rico at 1 site in Puerto Rico.
Trial summary
The overall goal of this educational program was to increase colorectal cancer screening (CRCS) in men and women who attend Federally Qualified Health Centers (FQHC) in Puerto Rico. 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?
- ¡Salud! Por la Vida
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 445 participants
- Where
- 1 sitePuerto Rico
- Study dates
- 8 Jul 2017to 2 Jul 2020
- 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
- Female aged 50-75, patient at a participating FQHC.
- Male aged 50-75, patient at a participating FQHC.
Who cannot join
- Having completed a fecal occult blood test (FOBT) or a fecal immunochemical test (FIT) in the past year.
- Having completed a sigmoidoscopy in the last 5 years.
- Having completed a colonoscopy in the last 10 years.
- Prior history of colorectal cancer.
Trial locations and contacts
1 site in 1 country.
Puerto Rico1 site
University of Puerto Rico, Medical Sciences Campus
San Juan, 00984
About this study
Official title: ¡Salud! Por la Vida: A Colorectal Screening Promotion Program for Patients Attending Federally Qualified Health Centers in Puerto Rico.
The overall goal of this educational program was to increase colorectal cancer screening (CRCS) in men and women who attend Federally Qualified Health Centers (FQHC) in Puerto Rico. FQHCs, referred to in Puerto Rico as "Clínicas 330", are ideal settings to implement innovative approaches to increase CRCS because they serve primarily low-income patients who typically have lower rates of screening. The goal of this study, is to develop and evaluate the impact of a clinic level intervention on increasing CRCS among low-income Puerto Rican men and women aged 50-75, who have either never been screened for colorectal cancer, or are under-screened according recommended guidelines. To evaluate the delivery of the CRCS education program we used a group randomized controlled trial that provided data to determine the effectiveness of the CRC intervention program compared with usual practice (no intervention).
- Conditions
- Colorectal Cancer
- Being tested
- ¡Salud! Por la Vida
- Keywords
- Hispanic/Latino, Behavioral Intervention, Lay Health Workers, Colorectal cancer, Colorectal cancer screening, Colonoscopy, cancer prevention
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
¡Salud! Por la VidaBehavioural
Lay health worker (LHW) delivered educational intervention for colorectal cancer screening (CRCS). The intervention consisted in having the participant complete a tailored interactive multimedia intervention (TIMI). TIMI consisted of a series of educational videos that addressed common barriers to colorectal cancer screening as well as provided information about colorectal cancer (CRC) and CRCS tests. Participants were able to tailor the TIMI for sex (male/female) and CRC family history. After TIMI completion, the LHW provided participant with a copy of the SPLV newsletter and printed infographics on CRC, CRCS, and an action plan tailored by type of CRCS (FOBT/FIT or colonoscopy). The Intervention Group subject participation took approx. up to 2 hours and Control Group up to 1 hour (half hour for each: baseline and follow-up interview). Follow-up data was collected 6 months post education session (intervention group) or post-baseline survey (control group).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Intervention Arm: ¡Salud! Por la vida Educational Intervention After completing eligibility and baseline surveys, trained lay health workers delivered an educational intervention for colorectal cancer screening with included a tailored interactive multimedia intervention (TIMI), newsletter, infographics, and a provider prompt for colorectal cancer screening. This educational session was delivered at intervention clinics and lasted about 1 hour. Follow-up data was collected starting at 6 months post educational session. Receives: Behavioral: ¡Salud! Por la Vida |
| Control Arm | No intervention | Control Arm: No intervention was delivered. At baseline, participants completed eligibility and baseline surveys. Follow-up data was collected 6 months post-baseline survey. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal Cancer Screening
Number of participants aged 50-75 who completed a colorectal cancer screening (FOBT, FIT, and/or colonoscopy) Screening behavior status at follow-up was assessed by asking patients the month and year of their last CRCS and by medical record review.
Measured: 6 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start8 Jul 2017
- Primary completion2 Jul 2020
- Study completion2 Jul 2020
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.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 445 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Puerto Rico
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Texas Health Science Center, Houston, M.D. Anderson Cancer Center, National Cancer Institute (NCI), National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Vivian Colon, University of Puerto Rico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502666
- Sponsor's protocol ID
- A8060116
- Acronym
- SPLV
- Status last verified
- Aug 2022
- First submitted
- 4 Aug 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Serra YA, Colon-Lopez V, Savas LS, Vernon SW, Fernandez-Espada N, Velez C, Ayala A, Fernandez ME. Using Intervention Mapping to Develop Health Education Components to Increase Colorectal Cancer Screening in Puerto Rico. Front Public Health. 2017 Dec 7;5:324. doi: 10.3389/fpubh.2017.00324. eCollection 2017.
PubMed 29270400Colon-Lopez V, Valencia-Torres IM, Rios EI, Llavona J, Velez-Alamo C, Fernandez ME. Knowledge, Attitudes, and Beliefs About Colorectal Cancer Screening in Puerto Rico. J Cancer Educ. 2023 Apr;38(2):552-561. doi: 10.1007/s13187-022-02153-z. Epub 2022 Mar 31.
PubMed 35359256
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ¡Salud! Por la Vida: A Colorectal Screening Promotion Program for Patients Attending Federally Qualified Health Centers in Puerto Rico.
- ClinicalTrials.gov ID
- NCT05502666
- Acronym / sponsor ID
- SPLV / A8060116
- Conditions
- Colorectal Cancer
- Keywords
- Hispanic/Latino, Behavioral Intervention, Lay Health Workers, Colorectal cancer, Colorectal cancer screening, Colonoscopy, cancer prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 445 participants (actual)
- Lead sponsor
- University of Puerto RicoUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center, Houston, M.D. Anderson Cancer Center, National Cancer Institute (NCI), National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 8 Jul 2017 (actual)
- Primary completion
- 2 Jul 2020 (actual)
- Study completion
- 2 Jul 2020 (actual)
- First posted
- 16 Aug 2022 (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 overall goal of this educational program was to increase colorectal cancer screening (CRCS) in men and women who attend Federally Qualified Health Centers (FQHC) in Puerto Rico. FQHCs, referred to in Puerto Rico as "Clínicas 330", are ideal settings to implement innovative approaches to increase CRCS because they serve primarily low-income patients who typically have lower rates of screening. The goal of this study, is to develop and evaluate the impact of a clinic level intervention on increasing CRCS among low-income Puerto Rican men and women aged 50-75, who have either never been screened for colorectal cancer, or are under-screened according recommended guidelines. To evaluate the delivery of the CRCS education program we used a group randomized controlled trial that provided data to determine the effectiveness of the CRC intervention program compared with usual practice (no intervention).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: ¡Salud! Por la VidaIntervention Arm: ¡Salud! Por la vida Educational Intervention After completing eligibility and baseline surveys, trained lay health workers delivered an educational intervention for colorectal cancer screening with included a tailored interactive multimedia intervention (TIMI), newsletter, infographics, and a provider prompt for colorectal cancer screening. This educational session was delivered at intervention clinics and lasted about 1 hour. Follow-up data was collected starting at 6 months post educational session. |
| Control Arm | No intervention | –Control Arm: No intervention was delivered. At baseline, participants completed eligibility and baseline surveys. Follow-up data was collected 6 months post-baseline survey. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female aged 50-75, patient at a participating FQHC.
- Male aged 50-75, patient at a participating FQHC.
Key exclusion criteria (4 listed)
- Having completed a fecal occult blood test (FOBT) or a fecal immunochemical test (FIT) in the past year.
- Having completed a sigmoidoscopy in the last 5 years.
- Having completed a colonoscopy in the last 10 years.
- Prior history of colorectal cancer.
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 |
|---|---|---|
| ¡Salud! Por la VidaLay health worker (LHW) delivered educational intervention for colorectal cancer screening (CRCS). The intervention consisted in having the participant complete a tailored interactive multimedia intervention (TIMI). TIMI consisted of a series of educational videos that addressed common barriers to colorectal cancer screening as well as provided information about colorectal cancer (CRC) and CRCS tests. Participants were able to tailor the TIMI for sex (male/female) and CRC family history. After TIMI completion, the LHW provided participant with a copy of the SPLV newsletter and printed infographics on CRC, CRCS, and an action plan tailored by type of CRCS (FOBT/FIT or colonoscopy). The Intervention Group subject participation took approx. up to 2 hours and Control Group up to 1 hour (half hour for each: baseline and follow-up interview). Follow-up data was collected 6 months post education session (intervention group) or post-baseline survey (control group). | Behavioural | Intervention Arm |
Primary outcome
Colorectal Cancer Screening
Time frame: 6 months after the intervention
Number of participants aged 50-75 who completed a colorectal cancer screening (FOBT, FIT, and/or colonoscopy) Screening behavior status at follow-up was assessed by asking patients the month and year of their last CRCS and by medical record review.
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 16 Aug 2022.
- Background: PubMed 29270400Serra YA, Colon-Lopez V, Savas LS, Vernon SW, Fernandez-Espada N, Velez C, Ayala A, Fernandez ME. Using Intervention Mapping to Develop Health Education Components to Increase Colorectal Cancer Screening in Puerto Rico. Front Public Health. 2017 Dec 7;5:324. doi: 10.3389/fpubh.2017.00324. eCollection 2017.
- Background: PubMed 35359256Colon-Lopez V, Valencia-Torres IM, Rios EI, Llavona J, Velez-Alamo C, Fernandez ME. Knowledge, Attitudes, and Beliefs About Colorectal Cancer Screening in Puerto Rico. J Cancer Educ. 2023 Apr;38(2):552-561. doi: 10.1007/s13187-022-02153-z. Epub 2022 Mar 31.
- ¡Salud! por la Vida Educational Materials in SpanishLink provided by the sponsor.
- ¡Salud! por la Vida Educational Materials in EnglishLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ¡Salud! Por la Vida in people with Colorectal Cancer, run by University of Puerto Rico at 1 site in Puerto Rico.
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 2 inclusion and 4 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 16 Aug 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 Puerto Rico. 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?
Colorectal Cancer Screening (time frame: 6 months after the intervention). 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 NCT05502666, 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 16 Aug 2022.