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Intervention to Improve Follow-up of Abnormal Pap Test

18 Years
55 Years
Open (Enrolling)
Cervical Cancer

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Trial Information

Intervention to Improve Follow-up of Abnormal Pap Test

Over 90% of deaths due to cervical cancer could be prevented with appropriate screening and
treatment of precursor lesions. However, 20% to 70% of women in the United States who are
told that their Papanicolaou (Pap) test was abnormal do not adhere to recommendations for
follow-up care. This is a problem especially among minorities and women of lower
socioeconomic status. The purpose of this part of the protocol is to test a theory-based
intervention designed to improve adherence to follow-up among women who experience an
abnormal Pap test. The intervention is a message, delivered over the telephone by a nurse,
at the time Pap test results are given to patients. The investigators propose to randomize
women who experience an abnormal Pap test to one of three groups: (1) targeted cultural
belief + knowledge + importance message (intervention), (2) nontargeted belief + knowledge +
importance (active control), or (3) standard care only (passive control). All three groups
will receive standard care, which is to notify women by telephone of their abnormal results
and provide instructions for follow-up. Women assigned to the intervention group also will
receive a cultural belief component consistent with their racial/ethnic group, detailed
information about follow-up procedures and the consequences of not returning for follow-up,
and information regarding the importance of adhering to recommendations, particularly for
"low grade" abnormalities. Women assigned to the active control group will receive a
nontargeted belief component, plus procedural knowledge and a message on the importance of
follow-up. Adherence to initial follow-up will be the primary outcome. Other behavioral
outcomes, such as delayed care and completeness of care, also will be assessed over an
18-month interval by chart review. Additionally, the investigators will evaluate
psychological outcomes including anxiety and distress. Finally, the investigators will
examine the grade of abnormality (low versus high) as an effect modifier. The investigators
anticipate that this research will result in an intervention that will improve several
important behavioral and psychological outcomes related to abnormal Pap test results. The
intervention is guided by a general integrative theoretical framework; therefore, this
research will evaluate an intervention strategy that recognizes the importance of targeting
culturally relevant beliefs about follow-up and key determinants of behavior
(knowledge/skills, salience, environmental constraints) surrounding abnormal Pap test
results. Ultimately, the objective of this research is to improve adherence to follow-up
among low-income, minority women who are at particular risk of developing cervical cancer.

Inclusion Criteria:

- Women aged 18 to 55 years who present to the UTMB clinics for Pap testing.

Exclusion Criteria:

- Women who are currently pregnant

- Have a current diagnosis of cervical cancer; or

- Who are unable to understand English or Spanish.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Adherence to initial follow-up (yes/no), delay in care, completeness of care

Outcome Time Frame:

as clinically recommended / 1 year chart follow-up

Safety Issue:


Principal Investigator

Carmen R Breitkopf, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Texas Medical Branch, Galveston


United States: Federal Government

Study ID:




Start Date:

October 2005

Completion Date:

December 2012

Related Keywords:

  • Cervical Cancer
  • unified theory of behavior
  • Pap test
  • cervical dysplasia
  • women's health
  • Uterine Cervical Neoplasms



University of Texas Medical Branch Galveston, Texas  77555-1329