Intervention to Improve Follow-up of Abnormal Pap Test



Status:Completed
Conditions:Cervical Cancer, Cervical Cancer, Cancer, Women's Studies
Therapuetic Areas:Oncology, Reproductive
Healthy:No
Age Range:18 - 55
Updated:8/25/2018
Start Date:October 2005
End Date:April 2012

Use our guide to learn which trials are right for you!

This project will examine whether a theory-based telephone intervention delivered by a nurse
at the time women are informed of an abnormal Pap test result will increase adherence to
follow-up recommendations.

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 University of Texas Medical Branch (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.
We found this trial at
1
site
301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
?
mi
from
Galveston, TX
Click here to add this to my saved trials