NCT02083770

Brief Summary

Hispanic Americans are underrepresented in cancer clinical trials. The purpose of this study is to develop and test programs designed to reduce barriers and increase facilitators associated with cancer clinical trials participation for Hispanic Americans.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,034

participants targeted

Target at P75+ for phase_3 cancer

Timeline
Completed

Started Mar 2010

Longer than P75 for phase_3 cancer

Geographic Reach
1 country

1 active site

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

March 1, 2010

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

8.4 years

First QC Date

March 4, 2014

Last Update Submit

March 3, 2020

Conditions

Cancer

Keywords

HispanicsPatient ParticipationRefusal to ParticipateEducationClinical Trials

Outcome Measures

Primary Outcomes (2)

  • Change in Participants' Clinical Trials-Related Knowledge, Attitudes and Beliefs From Baseline to First Follow-up

    To assess the impact of the intervention arm on participants' knowledge, attitudes, and perceptions related to clinical trials, they were asked to complete the same surveys given at baseline during post-intervention immediately after intervention.

    Change from baseline to first follow-up (immediately after receiving intervention)

  • Change in Participants' Clinical Trials-Related Knowledge, Attitudes and Beliefs From Baseline to Second Follow-up

    At the three-month follow-up, participants were mailed the final packet of survey instruments to complete and return in a stamped, self-addressed envelope.

    Change from baseline to second follow-up (three months after receiving intervention)

Secondary Outcomes (1)

  • Willingness to Participate in Research

    Two weeks after receiving intervention

Study Arms (2)

Cancer Clinical Trials Education Program

EXPERIMENTAL

Cancer Clinical Trials Education Program is offered to English- and Spanish-speaking Hispanics in the experimental arm. This program was designed to promote increased clinical trials literacy among Hispanic Americans. Increased clinical trials knowledge and a better understanding of clinical trials is anticipated to create more positive attitudes, and perceptions about clinical trials among Hispanic Americans.

Behavioral: Cancer Clinical Trials Education Program

Neighborhood Watch Education Program

PLACEBO COMPARATOR

The Neighborhood Watch Program created by the Bureau of Justice Assistance and the National Crime Prevention Council was selected for inclusion in the control arm of this study. It provided participants with a program of equivalent length and format, as well as an equivalent focus on improving the well-being of Hispanic Americans. It also provided an opportunity to evaluate the impact of the Neighborhood Watch Program.

Behavioral: Cancer Clinical Trials Education Program

Interventions

Cancer Clinical Trials Education ProgramBEHAVIORAL

Hispanic Americans are underrepresented in cancer clinical trials. The purpose of this study is to develop and test programs designed to reduce barriers and increase facilitators associated with cancer clinical trials participation for Hispanic Americans.

Cancer Clinical Trials Education ProgramNeighborhood Watch Education Program

Eligibility Criteria

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

You may qualify if:

  • Self-identified as Hispanic American
  • At least 21 years of age
  • Sufficiently literate to comprehend written and spoken testing materials in English or Spanish
  • Living in southern California
  • Mentally competent to complete the informed consenting process

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC San Diego Moores Cancer Center

La Jolla, California, 92093-0850, United States

Location

Related Publications (1)

  • Merz EL, Malcarne VL, Roesch SC, Riley N, Sadler GR. A multigroup confirmatory factor analysis of the Patient Health Questionnaire-9 among English- and Spanish-speaking Latinas. Cultur Divers Ethnic Minor Psychol. 2011 Jul;17(3):309-316. doi: 10.1037/a0023883.

    PMID: 21787063BACKGROUND

MeSH Terms

Conditions

NeoplasmsPatient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Georgia R Sadler, PhD

    UC San Diego Moores Cancer Center

    PRINCIPAL INVESTIGATOR

  • Vanessa L Malcarne, PhD

    San Diego State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 11, 2014

Study Start

March 1, 2010

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

March 4, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)