Clinical trial NCT01760850: Breast and Cervical Cancer Educational Intervention for Latinas in Western New York
Official title: Investigating a Breast and Cervical Cancer Intervention for Latinas in Western New York
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Cervical Cancer
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2013-01-04
Enrollment: 959
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Screening rates
timeFrame: 2 months
measure: Screening rates
timeFrame: 8 months
measure: Knowledge acquisition
timeFrame: 2 months
measure: Knowledge acquisition
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Deborah Erwin
role: PRINCIPAL_INVESTIGATOR
References: