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CompletedNCT01525433Updated Nov 13, 2018

Cervical Cancer Screening Among Hispanic Women

An interventional study of DVD and Promotora in Cervical Cancer, sponsored by Fred Hutchinson Cancer Center. Completed at 1 site in United States. Open to female participants aged 21 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-13.

Sponsored by Fred Hutchinson Cancer Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
451
Allocation
Randomized
Ages
21 Years to 64 Years
Sex
Female
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Study 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)

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Conditions studied

  • Cervical Cancer
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In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's enrollment of 451 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Fred Hutchinson Cancer Center is the lead sponsor of 537 studies on the registry; 79 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 45 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 64 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
451 participants (actual)

Study arms

  • No intervention
    Control
  • Active comparator
    Low Intensity Information (DVD)

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

    Behavioral: DVD

  • Active comparator
    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.

    Behavioral: Promotora

Interventions

  • BehavioralDVD

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

  • BehavioralPromotora

    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

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What researchers measure

Primary outcomes

  1. Participant attends cervical cancer screening

    Time frame: Within 7 months of the intervention

Secondary outcomes

  1. 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.

    Time frame: Elapsed time from diagnosis to clinic visit

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Study locations

1 site
  • Fred Hutchinson Cancer Research Center
    Seattle, Washington 98109, United States
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References and documents

Publications

  • 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. PubMed 22559251 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01525433
Lead sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Feb 3, 2012
Start date
Sep 2011
Primary completion
Sep 2015
Completion
Jul 17, 2018
Last update
Nov 13, 2018

Study contacts

Beti Thompson, PhD
principal investigator · Fred Hutchinson Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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