CancerCRUZANCT01740219
Promoting Organizational Capacity to Implement Cancer Control Programs Among Latino Churches
A study testing Capacity Enhancement and Standard Dissemination in people with Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial summary
This research study aims to develop an organizational-level intervention to enable communities to adopt, adapt, implement and sustain evidence-based interventions (EBIs) to address cancer disparities among Latinos. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Capacity Enhancement and Standard Dissemination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2011to Sep 2013
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parishes eligible for the Randomized trial are those that are: Roman Catholic, located in Massachusetts, offer religious services in Spanish, and have taken part in the organizational survey.
Who cannot join
- Not Roman Catholic, not located in Massachusetts, don't offer religious services in Spanish, and have not participated in the organizational survey.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Massachusetts Boston
Boston, Massachusetts, 02125
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Tufts University
Medford, Massachusetts, 02144
About this study
Official title: Promoting the Utilization of Cancer Early Detection Methods Among Latinos in Church: a Faith-based Approach
This research study aims to develop an organizational-level intervention to enable communities to adopt, adapt, implement and sustain evidence-based interventions (EBIs) to address cancer disparities among Latinos. The investigators partner with faith-based organizations, since they play a highly prominent role in Latino community life. This three-phase study will: (1) improve understanding of the organizational infrastructure, skills and resources required by Latino churches to implement EBIs for cancer control, (2) develop a capacity-building intervention; and (3) test the intervention's effectiveness in a randomized trial.
- Conditions
- Cancer
- Being tested
- Capacity Enhancement, Standard Dissemination
- Keywords
- Health promotion, Religion and medicine, Hispanic Americans, Randomized controlled trial, Program evaluation, Neoplasms/prevention & control, Mass screening, Female, Male, Preventive Health Services/methods, Adult, Organizations
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capacity EnhancementBehavioural
Churches in the Capacity Enhancement intervention will be invited to work with CRUZA staff over the course of a three month intervention to implement health promotion activities in their church and participate in capacity-building educational workshops. Participants may also receive technical assistance from Health Educators in order to implement their cancer education activities.
Standard DisseminationBehavioural
Churches in the Standard Dissemination arm will receive program materials with information about cancer prevention/early detection and health resources.
| Study group | Role | What they receive |
|---|---|---|
| Capacity Enhancement | Experimental | Not described Receives: Behavioral: Capacity Enhancement |
| Standard Dissemination | Active comparator | Not described Receives: Behavioral: Standard Dissemination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation
Number and types of interventions offered
Measured: 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startSep 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Boston
- Responsible party
- Principal investigator, Jennifer Allen, Dana-Farber Cancer Institute
- Investigators
- Jennifer D Allen, ScD, Principal investigator, Dana-Farber Cancer InstituteMaria Idali Torres, PhD, Principal investigator, University of Massachusetts, Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740219
- Sponsor's protocol ID
- 19674
- Acronym
- CRUZA
- Status last verified
- Jun 2019
- First submitted
- 30 Nov 2012
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Allen JD, Shelton RC, Kephart L, Jandorf L, Folta SC, Knott CL. Organizational characteristics conducive to the implementation of health programs among Latino churches. Implement Sci Commun. 2020 Jul 6;1:62. doi: 10.1186/s43058-020-00052-2. eCollection 2020.
PubMed 32885217Allen JD, Shelton RC, Kephart L, Tom LS, Leyva B, Ospino H, Cuevas AG. Examining the external validity of the CRUZA study, a randomized trial to promote implementation of evidence-based cancer control programs by faith-based organizations. Transl Behav Med. 2020 Feb 3;10(1):213-222. doi: 10.1093/tbm/iby099.
PubMed 30496532Allen JD, Torres MI, Tom LS, Leyva B, Galeas AV, Ospino H. Dissemination of evidence-based cancer control interventions among Catholic faith-based organizations: results from the CRUZA randomized trial. Implement Sci. 2016 May 18;11(1):74. doi: 10.1186/s13012-016-0430-6.
PubMed 27193768
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting the Utilization of Cancer Early Detection Methods Among Latinos in Church: a Faith-based Approach
- ClinicalTrials.gov ID
- NCT01740219
- Acronym / sponsor ID
- CRUZA / 19674
- Conditions
- Cancer
- Keywords
- Health promotion, Religion and medicine, Hispanic Americans, Randomized controlled trial, Program evaluation, Neoplasms/prevention & control, Mass screening, Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- University of Massachusetts, Boston
- Study start
- Sep 2011 (actual)
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 4 Dec 2012 (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 research study aims to develop an organizational-level intervention to enable communities to adopt, adapt, implement and sustain evidence-based interventions (EBIs) to address cancer disparities among Latinos. The investigators partner with faith-based organizations, since they play a highly prominent role in Latino community life. This three-phase study will: (1) improve understanding of the organizational infrastructure, skills and resources required by Latino churches to implement EBIs for cancer control, (2) develop a capacity-building intervention; and (3) test the intervention's effectiveness in a randomized trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capacity Enhancement | Experimental | Behavioral: Capacity Enhancement |
| Standard Dissemination | Active comparator | Behavioral: Standard Dissemination |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Parishes eligible for the Randomized trial are those that are: Roman Catholic, located in Massachusetts, offer religious services in Spanish, and have taken part in the organizational survey.
Key exclusion criteria (1 listed)
- Not Roman Catholic, not located in Massachusetts, don't offer religious services in Spanish, and have not participated in the organizational survey.
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 |
|---|---|---|
| Capacity EnhancementChurches in the Capacity Enhancement intervention will be invited to work with CRUZA staff over the course of a three month intervention to implement health promotion activities in their church and participate in capacity-building educational workshops. Participants may also receive technical assistance from Health Educators in order to implement their cancer education activities. | Behavioural | Capacity Enhancement |
| Standard DisseminationChurches in the Standard Dissemination arm will receive program materials with information about cancer prevention/early detection and health resources. | Behavioural | Standard Dissemination |
Primary outcome
Implementation
Time frame: 3-months
Number and types of interventions offered
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 20 Jun 2019.
- Derived from this study: PubMed 32885217Allen JD, Shelton RC, Kephart L, Jandorf L, Folta SC, Knott CL. Organizational characteristics conducive to the implementation of health programs among Latino churches. Implement Sci Commun. 2020 Jul 6;1:62. doi: 10.1186/s43058-020-00052-2. eCollection 2020.
- Derived from this study: PubMed 30496532Allen JD, Shelton RC, Kephart L, Tom LS, Leyva B, Ospino H, Cuevas AG. Examining the external validity of the CRUZA study, a randomized trial to promote implementation of evidence-based cancer control programs by faith-based organizations. Transl Behav Med. 2020 Feb 3;10(1):213-222. doi: 10.1093/tbm/iby099.
- Derived from this study: PubMed 27193768Allen JD, Torres MI, Tom LS, Leyva B, Galeas AV, Ospino H. Dissemination of evidence-based cancer control interventions among Catholic faith-based organizations: results from the CRUZA randomized trial. Implement Sci. 2016 May 18;11(1):74. doi: 10.1186/s13012-016-0430-6.
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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.
Jennifer D Allen, ScD principal investigator
Dana-Farber Cancer Institute
Maria Idali Torres, PhD principal investigator
University of Massachusetts, Boston
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capacity Enhancement and Standard Dissemination in people with Cancer, run by Dana-Farber Cancer Institute at 3 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 1 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 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Implementation (time frame: 3-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 NCT01740219, which also lists 3 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 20 Jun 2019.