Overview

This trial is active, not recruiting.

Condition cervical cancer
Treatments dvd, promotora
Sponsor Fred Hutchinson Cancer Research Center
Collaborator National Cancer Institute (NCI)
Start date September 2011
End date September 2015
Trial size 451 participants
Trial identifier NCT01525433, FHCRC IR 7290, U54CA153502

Summary

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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(No Intervention)
(Active Comparator)
A low-intensity information program, consisting of a video approach educating women on the importance of cervical cancer screening;
dvd
Participants will received a mailed DVD containing culturally appropriate information about the importance of cervical cancer screening
(Active Comparator)
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.
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

Primary Outcomes

Measure
Participant attends cervical cancer screening
time frame: Within 7 months of the intervention

Secondary Outcomes

Measure
Patient Navigator
time frame: Elapsed time from diagnosis to clinic visit

Eligibility Criteria

Female participants from 21 years up to 64 years old.

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

Additional Information

Official title Cervical Cancer Screening and Adherence to Follow-up Among Hispanic Women
Principal investigator Beti Thompson, PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Fred Hutchinson Cancer Research Center.