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

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ClinicalTrials.gov Identifier: NCT01760850
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : July 23, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

January 2, 2013
January 4, 2013
July 23, 2015
June 2007
May 2012   (Final data collection date for primary outcome measure)
  • Screening rates [ Time Frame: 2 months ]
    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 ]
    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 ]
    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 ]
    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.
Same as current
Complete list of historical versions of study NCT01760850 on ClinicalTrials.gov Archive Site
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Breast and Cervical Cancer Educational Intervention for Latinas in Western New York
Investigating a Breast and Cervical Cancer Intervention for Latinas in Western New York
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Breast Cancer
  • Cervical Cancer
  • Other: educational intervention
    Engage in the Esperanza y Vida educational information session for breast and cervical cancer
    Other Name: intervention, educational
  • Other: educational intervention
    Engage in an educational information session for diabetes
    Other Name: intervention, educational
  • Other: questionnaire administration
    Ancillary studies
  • Experimental: Arm I (Esperanza y Vida)
    Participants engage in the Esperanza y Vida educational information session for breast and cervical cancer.
    Interventions:
    • Other: educational intervention
    • Other: questionnaire administration
  • Active Comparator: Arm II (control)
    Participants engage in an educational information session for diabetes.
    Interventions:
    • Other: educational intervention
    • Other: questionnaire administration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
959
1100
April 2015
May 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01760850
I 105707
NCI-2012-02850 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
No
Not Provided
Not Provided
Roswell Park Cancer Institute
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Deborah Erwin Roswell Park Cancer Institute
Roswell Park Cancer Institute
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP