Breast and Cervical Cancer Educational Intervention for Latinas in Western New York

October 3, 2022 updated by: Roswell Park Cancer Institute

Investigating a Breast and Cervical Cancer Intervention for Latinas in Western New York

This pilot clinical trial studies a breast and cervical cancer educational intervention for Latinas in Western New York. An outreach program may help minority cancer patients overcome problems that keep them from receiving cancer screening.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. Investigate the extent of linguistic and cultural tailoring necessary to adapt Esperanza y Vida outreach programs for Hispanics in Western New York.

II. Evaluate the effectiveness of the Esperanza y Vida program intervention to increase breast and cervical cancer knowledge and screening behaviors in Hispanic participants compared to a control health education program on diabetes.

III. Determine the factors associated with and/or predictive of screening of Hispanics in Western New York (WNY) as compared to New York City (NYC) and Arkansas to describe how the intervention impacts barriers and motivations for screening in diverse Hispanic populations.

OUTLINE:

Key informant interviews with local "gatekeepers" of Hispanic culture groups in WNY and focus groups with Hispanic cancer survivors with screened and unscreened participants are conducted during the first phase of research. Participants are then randomized to 1 of 2 arms.

ARM I: Participants engage in the Esperanza y Vida educational information session for breast and cervical cancer.

ARM II: Participants engage in an educational information session for diabetes.

After completion of study treatment, participants are followed up at 2 and 8 months.

Study Type

Interventional

Enrollment (Actual)

959

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women who are generally healthy, ambulatory, and able to participate in social events in their communities
  • No women, men, or children of any ethnic or social background are ever excluded from the educational programs, although recruitment will focus on Hispanic/Latinos
  • Children may be present with parents, but will not be included in any research activities, unless they are emancipated minors (under 18 and married)
  • Men are included in all of the research activities, but will not be included in the follow-up telephone surveys to assess breast and cervical screening as they do not obtain screening Pap smears, clinical breast exams, or mammograms; men may be asked about their intent to assist women in obtaining screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (Esperanza y Vida)
Participants engage in the Esperanza y Vida educational information session for breast and cervical cancer.
Other: questionnaire administration
Ancillary studies
Other: educational intervention
Engage in the Esperanza y Vida educational information session for breast and cervical cancer
Other Names:
  • intervention, educational
Other: educational intervention
Engage in an educational information session for diabetes
Other Names:
  • intervention, educational
Active Comparator: Arm II (control)
Participants engage in an educational information session for diabetes.
Other: questionnaire administration
Ancillary studies
Other: educational intervention
Engage in the Esperanza y Vida educational information session for breast and cervical cancer
Other Names:
  • intervention, educational
Other: educational intervention
Engage in an educational information session for diabetes
Other Names:
  • intervention, educational

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Screening rates
Time Frame: 2 months
Intervention-group screening rates will be compared for evidence of increase over control-group screening rates using the Chi-square test, conducted as a one-sided test at alpha = 0.05. And in stratified analysis, screening rates across both states will be compared for evidence of an overall increase with intervention using the Cochran-mantel-Haenszel (CMH) test, conducted as a one-sided test at alpha = 0.05.
2 months
Screening rates
Time Frame: 8 months
Intervention-group screening rates will be compared for evidence of increase over control-group screening rates using the Chi-square test, conducted as a one-sided test at alpha = 0.05. And in stratified analysis, screening rates across both states will be compared for evidence of an overall increase with intervention using the CMH test, conducted as a one-sided test at alpha = 0.05.
8 months
Knowledge acquisition
Time Frame: 2 months
Knowledge acquisition within the intervention group will be assessed using the 1-sided paired t-test at alpha = 0.05, while differences in knowledge acquisition between groups will be assessed using Analysis of Covariance (ANCOVA).
2 months
Knowledge acquisition
Time Frame: 8 months
Knowledge acquisition within the intervention group will be assessed using the 1-sided paired t-test at alpha = 0.05, while differences in knowledge acquisition between groups will be assessed using ANCOVA.
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Investigators

  • Principal Investigator: Deborah Erwin, Roswell Park Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

May 1, 2012

Study Completion

April 1, 2015

Study Registration Dates

First Submitted

January 2, 2013

First Submitted That Met QC Criteria

January 3, 2013

First Posted (Estimate)

January 4, 2013

Study Record Updates

Last Update Posted (Actual)

October 5, 2022

Last Update Submitted That Met QC Criteria

October 3, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I 105707
  • NCI-2012-02850 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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