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OpenTrials
Completed

NCT Number: NCT01525433

Cervical Cancer Screening Among Hispanic Women

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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Key information

Conditions

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

Age range

21 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DVD

Behavioral

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

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

Primary outcomes

  1. Participant attends cervical cancer screening

    Time frame: Within 7 months of the intervention

Secondary outcomes

  1. Patient Navigator

    Time frame: Elapsed time from diagnosis to clinic visit

    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.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2018
First posted
Feb 3, 2012
Registry last updated
Nov 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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