Breast CancerNCT01760850
Breast and Cervical Cancer Educational Intervention for Latinas in Western New York
A study testing educational intervention and questionnaire administration in people with Breast Cancer and Cervical Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Cervical Cancer
- What is being tested?
- educational intervention and questionnaire administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 959 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Breast Cancer, Cervical Cancer
- Being tested
- educational intervention, questionnaire administration
- Medical subject headings
- Breast Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational interventionOther
Also called intervention, educational
Engage in the Esperanza y Vida educational information session for breast and cervical cancer
educational interventionOther
Also called intervention, educational
Engage in an educational information session for diabetes
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Esperanza y Vida) | Experimental | Participants engage in the Esperanza y Vida educational information session for breast and cervical cancer. Receives: Other: educational intervention; Other: questionnaire administration |
| Arm II (control) | Active comparator | Participants engage in an educational information session for diabetes. Receives: Other: educational intervention; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startJun 2007
- Primary completionMay 2012
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 959 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deborah Erwin, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01760850
- Sponsor's protocol ID
- I 105707
- Other IDs
- NCI-2012-02850
- Status last verified
- Oct 2022
- First submitted
- 2 Jan 2013
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating a Breast and Cervical Cancer Intervention for Latinas in Western New York
- ClinicalTrials.gov ID
- NCT01760850
- Acronym / sponsor ID
- I 105707
- Conditions
- Breast Cancer, Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 959 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- May 2012 (actual)
- Study completion
- Apr 2015
- First posted
- 4 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Esperanza y Vida) | Experimental | Other: educational intervention, Other: questionnaire administrationParticipants engage in the Esperanza y Vida educational information session for breast and cervical cancer. |
| Arm II (control) | Active comparator | Other: educational intervention, Other: questionnaire administrationParticipants engage in an educational information session for diabetes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educational interventionAlso: intervention, educationalEngage in the Esperanza y Vida educational information session for breast and cervical cancer | Other | Arm I (Esperanza y Vida) |
| educational interventionAlso: intervention, educationalEngage in an educational information session for diabetes | Other | Arm II (control) |
| questionnaire administrationAncillary studies | Other | Arm I (Esperanza y Vida), Arm II (control) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Erwin principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational intervention and questionnaire administration in people with Breast Cancer and Cervical Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening rates (time frame: 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.