Breast and Cervical Cancer Educational Intervention for Latinas in Western New York
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer Cervical Cancer |
Other: educational intervention Other: questionnaire administration |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Investigating a Breast and Cervical Cancer Intervention for Latinas in Western New York |
- Screening rates [ Time Frame: 2 months ] [ Designated as safety issue: No ]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.
- Screening rates [ Time Frame: 8 months ] [ Designated as safety issue: No ]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 [ Time Frame: 2 months ] [ Designated as safety issue: No ]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).
- Knowledge acquisition [ Time Frame: 8 months ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 1100 |
| Study Start Date: | June 2007 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I (Esperanza y Vida)
Participants engage in the Esperanza y Vida educational information session for breast and cervical cancer.
|
Other: educational intervention
Engage in the Esperanza y Vida educational information session for breast and cervical cancer
Other Name: intervention, educational
Other: questionnaire administration
Ancillary studies
|
|
Active Comparator: Arm II (control)
Participants engage in an educational information session for diabetes.
|
Other: educational intervention
Engage in an educational information session for diabetes
Other Name: intervention, educational
Other: questionnaire administration
Ancillary studies
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263 | |
| Principal Investigator: | Deborah Erwin | Roswell Park Cancer Institute |
More Information
No publications provided
| Responsible Party: | Roswell Park Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT01760850 History of Changes |
| Other Study ID Numbers: | I 105707, NCI-2012-02850 |
| Study First Received: | January 2, 2013 |
| Last Updated: | January 7, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Breast Neoplasms Uterine Cervical Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on June 18, 2013