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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer, Cervical Cancer

Intervention / Treatment
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* Other: educational intervention
* Other: educational intervention
* Other: questionnaire administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screening rates | 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 | 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 | 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 | 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 |