Cervical Cancer Screening Among Hispanic Women

NCT01525433 | Completed

• 2 other identifiers: FHCRC IR 7290U54CA153502
• Study Type: interventional
• Target: 451
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 1.Control (no change);
2. 2.A low-intensity information program, consisting of a video approach educating women on the importance of cervical cancer screening;
3. 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.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Participant attends cervical cancer screening

  Within 7 months of the intervention

Secondary Outcomes (1)

• Patient Navigator

  Elapsed time from diagnosis to clinic visit

Study Arms (3)

Control

NO INTERVENTION

Low Intensity Information (DVD)

ACTIVE COMPARATOR

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

Behavioral: DVD

High Intensity Information (Promotora)

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.

Behavioral: Promotora

Interventions

DVD BEHAVIORAL

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

Low Intensity Information (DVD)

Promotora 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

High Intensity Information (Promotora)

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• 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

You may not qualify if:

• Less than 21 or greater than 64 years of age
• PAP test less 3 years ago
• Prior hysterectomy

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• 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.

  PMID: 22559251 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Beti Thompson, PhD

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2012
• First Posted: February 3, 2012
• Study Start: September 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: July 17, 2018
• Last Updated: November 13, 2018

Record last verified: 2018-11

Locations

US (1)