Cervical Cancer Screening Among Hispanic Women

NCT ID: NCT01525433

Last Updated: 2018-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

451 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2018-07-17

Brief Summary

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In this study, 400 Hispanic women will be recruited and randomized to one of three interventions:

1. Control (no change);
2. A low-intensity information program, consisting of a video approach educating women on the importance of cervical cancer screening;
3. A higher intensity program consisting of the video plus a 'promotora' or lay-community health educator led intervention at the participant's home to encourage cervical cancer screening.

The investigators will compare which intervention is most effective in encouraging Hispanic women to undergo cervical cancer screening (Pap test)

Detailed Description

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Conditions

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Cervical Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Low Intensity Information (DVD)

A low-intensity information program, consisting of a video approach educating women on the importance of cervical cancer screening;

Group Type ACTIVE_COMPARATOR

DVD

Intervention Type BEHAVIORAL

Participants will received a mailed DVD containing culturally appropriate information about the importance of cervical cancer screening

High Intensity Information (Promotora)

A higher intensity information program consisting of the video plus a 'promotora' or lay-community health educator led-intervention at the participant's home to encourage cervical cancer screening.

Group Type ACTIVE_COMPARATOR

Promotora

Intervention Type BEHAVIORAL

Participants will receive a home visit from a lay community health educator ('Promotora') and will be shown a DVD containing culturally appropriate information to educate participants about the importance of cervical cancer screening

Interventions

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DVD

Participants will received a mailed DVD containing culturally appropriate information about the importance of cervical cancer screening

Intervention Type BEHAVIORAL

Promotora

Participants will receive a home visit from a lay community health educator ('Promotora') and will be shown a DVD containing culturally appropriate information to educate participants about the importance of cervical cancer screening

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Female
* 21 - 64 years of age
* Hispanic or Latina
* Resident of the Yakima Valley, WA, USA
* No hysterectomy
* Last PAP test (cervical screening) more than 3 years ago
* Last seen at the local clinic less than 5 years ago

Exclusion Criteria

* Less than 21 or greater than 64 years of age
* PAP test less 3 years ago
* Prior hysterectomy
Minimum Eligible Age

21 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beti Thompson, PhD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Locations

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Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Duggan C, Coronado G, Martinez J, Byrd TL, Carosso E, Lopez C, Benavides M, Thompson B. Cervical cancer screening and adherence to follow-up among Hispanic women study protocol: a randomized controlled trial to increase the uptake of cervical cancer screening in Hispanic women. BMC Cancer. 2012 May 6;12:170. doi: 10.1186/1471-2407-12-170.

Reference Type DERIVED
PMID: 22559251 (View on PubMed)

Other Identifiers

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U54CA153502

Identifier Type: NIH

Identifier Source: secondary_id

View Link

FHCRC IR 7290

Identifier Type: -

Identifier Source: org_study_id

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