Breast and Cervical Cancer Educational Intervention for Latinas in Western New York
Primary Purpose
Breast Cancer, Cervical Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
educational intervention
educational intervention
questionnaire administration
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer
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
Sites / Locations
- Roswell Park Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm I (Esperanza y Vida)
Arm II (control)
Arm Description
Participants engage in the Esperanza y Vida educational information session for breast and cervical cancer.
Participants engage in an educational information session for diabetes.
Outcomes
Primary Outcome Measures
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.
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.
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).
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01760850
First Posted
January 2, 2013
Last Updated
October 3, 2022
Sponsor
Roswell Park Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT01760850
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
April 2015 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cervical Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
959 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I (Esperanza y Vida)
Arm Type
Experimental
Arm Description
Participants engage in the Esperanza y Vida educational information session for breast and cervical cancer.
Arm Title
Arm II (control)
Arm Type
Active Comparator
Arm Description
Participants engage in an educational information session for diabetes.
Intervention Type
Other
Intervention Name(s)
educational intervention
Other Intervention Name(s)
intervention, educational
Intervention Description
Engage in the Esperanza y Vida educational information session for breast and cervical cancer
Intervention Type
Other
Intervention Name(s)
educational intervention
Other Intervention Name(s)
intervention, educational
Intervention Description
Engage in an educational information session for diabetes
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Screening rates
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.
Time Frame
2 months
Title
Screening rates
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 CMH test, conducted as a one-sided test at alpha = 0.05.
Time Frame
8 months
Title
Knowledge acquisition
Description
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).
Time Frame
2 months
Title
Knowledge acquisition
Description
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.
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Erwin
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Breast and Cervical Cancer Educational Intervention for Latinas in Western New York
We'll reach out to this number within 24 hrs