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

Roswell Park Comprehensive Cancer Center

Status: Completed

Conditions: Breast Cancer; Cervical Cancer

Treatments: Other: educational intervention; Other: questionnaire administration

Study type: Interventional

Funder types: Other

Identifiers

NCT01760850

I 105707

NCI-2012-02850 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 959 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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959 participants in 2 patient groups

Arm I (Esperanza y Vida)

Experimental group

Description:

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

Treatment:

Other: educational intervention

Other: questionnaire administration

Other: educational intervention

Arm II (control)

Active Comparator group

Description:

Participants engage in an educational information session for diabetes.

Treatment:

Other: educational intervention

Other: questionnaire administration

Other: educational intervention