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

Not Applicable

Completed

• Conditions: Breast Cancer; Cervical Cancer
• Interventions: Other: educational intervention; Other: questionnaire administration

• Registration Number: NCT01760850
• Lead Sponsor: Roswell Park Cancer Institute

Brief Summary

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.

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 Timeline

• Study Start: 2007-06
• Primary Completion: 2012-05
• Study First Submitted: 2013-01-02
• Study First Submitted QC: 2013-01-03
• Study First Posted: 2013-01-04
• Study Completion: 2015-04
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-03
• Last Update Posted: 2022-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 959

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (control)	questionnaire administration	Participants engage in an educational information session for diabetes.
Arm I (Esperanza y Vida)	educational intervention	Participants engage in the Esperanza y Vida educational information session for breast and cervical cancer.
Arm I (Esperanza y Vida)	questionnaire administration	Participants engage in the Esperanza y Vida educational information session for breast and cervical cancer.
Arm II (control)	educational intervention	Participants engage in an educational information session for diabetes.

Primary Outcome Measures

Name	Time	Method
Screening rates	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.
Knowledge acquisition	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.

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States