Investigating a Breast and Cervical Cancer Intervention for Latinas in Western New York
18 Years
N/A
Both
Breast Cancer, Cervical Cancer
Trial Information
Investigating a Breast and Cervical Cancer Intervention for Latinas in Western New York
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Screening rates
Outcome Description:
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.
Outcome Time Frame:
2 months
Safety Issue:
No
Principal Investigator
Deborah Erwin
Investigator Role:
Principal Investigator
Investigator Affiliation:
Roswell Park Cancer Institute
Authority:
United States: Institutional Review Board
Study ID:
I 105707
NCT ID:
NCT01760850
Start Date:
June 2007
Completion Date:
Related Keywords:
- Breast Cancer
- Cervical Cancer
- Breast Neoplasms
- Uterine Cervical Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
