NCT01740219

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
348

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

June 20, 2019

Status Verified

June 1, 2019

Enrollment Period

2 years

First QC Date

November 30, 2012

Last Update Submit

June 18, 2019

Conditions

Cancer

Keywords

Health promotionReligion and medicineHispanic AmericansRandomized controlled trialProgram evaluationNeoplasms/prevention & controlMass screeningFemaleMalePreventive Health Services/methodsAdultOrganizations

Outcome Measures

Primary Outcomes (1)

  • Implementation

    Number and types of interventions offered

    3-months

Study Arms (2)

Capacity Enhancement

EXPERIMENTAL
Behavioral: Capacity Enhancement

Standard Dissemination

ACTIVE COMPARATOR
Behavioral: Standard Dissemination

Interventions

Capacity EnhancementBEHAVIORAL

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.

Capacity Enhancement
Standard DisseminationBEHAVIORAL

Churches in the Standard Dissemination arm will receive program materials with information about cancer prevention/early detection and health resources.

Standard Dissemination

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Not Roman Catholic, not located in Massachusetts, don't offer religious services in Spanish, and have not participated in the organizational survey.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Massachusetts Boston

Boston, Massachusetts, 02125, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Tufts University

Medford, Massachusetts, 02144, United States

Location

Related Publications (3)

  • 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.

    PMID: 32885217DERIVED

  • Allen 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.

    PMID: 30496532DERIVED

  • Allen 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.

    PMID: 27193768DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Jennifer D Allen, ScD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

  • Maria Idali Torres, PhD

    University of Massachusetts, Boston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 30, 2012

First Posted

December 4, 2012

Study Start

September 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

June 20, 2019

Record last verified: 2019-06

Locations

US(3)