NCT01760850

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
959

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jun 2007

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

October 5, 2022

Status Verified

October 1, 2022

Enrollment Period

4.9 years

First QC Date

January 2, 2013

Last Update Submit

October 3, 2022

Conditions

Breast CancerCervical Cancer

Outcome Measures

Primary Outcomes (4)

  • 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.

    2 months

  • 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.

    8 months

  • 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).

    2 months

  • 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.

    8 months

Study Arms (2)

Arm I (Esperanza y Vida)

EXPERIMENTAL

Participants engage in the Esperanza y Vida educational information session for breast and cervical cancer.

Other: educational interventionOther: questionnaire administration

Arm II (control)

ACTIVE COMPARATOR

Participants engage in an educational information session for diabetes.

Other: educational interventionOther: questionnaire administration

Interventions

educational interventionOTHER

Engage in the Esperanza y Vida educational information session for breast and cervical cancer

Also known as: intervention, educational
Arm I (Esperanza y Vida)
questionnaire administrationOTHER

Ancillary studies

Arm I (Esperanza y Vida)Arm II (control)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsUterine Cervical Neoplasms

Interventions

Early Intervention, EducationalMethods

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesInvestigative Techniques

Study Officials

  • Deborah Erwin

    Roswell Park Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2013

First Posted

January 4, 2013

Study Start

June 1, 2007

Primary Completion

May 1, 2012

Study Completion

April 1, 2015

Last Updated

October 5, 2022

Record last verified: 2022-10

Locations

US(1)