Cervical Cancer Screening Among Hispanic Women

Cervical Cancer Clinical Trial

Official title:

Cervical Cancer Screening and Adherence to Follow-up Among Hispanic Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01525433
• Other study ID #: FHCRC IR 7290
• Secondary ID: U54CA153502
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: July 17, 2018

Study information

• Verified date: November 2018
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 451
• Est. completion date: July 17, 2018
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• DVD
Participants will received a mailed DVD containing culturally appropriate information about the importance of 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

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant attends cervical cancer screening		Within 7 months of the intervention
Secondary	Patient Navigator	Evaluation of the patient navigator program as a method to improve adherence and reduce time to follow-up among study participants who receive an abnormal Pap test result. Time to follow-up will be compared to a similar population of patients who were not part of the study who also receive a diagnosis of an abnormal Pap test.	Elapsed time from diagnosis to clinic visit