This trial is active, not recruiting.

Condition cervical cancer
Treatments full active intervention, active control
Sponsor The University of Texas, Galveston
Start date October 2005
End date August 2012
Trial size 3555 participants
Trial identifier NCT00575510, 05-245, R01CA107015


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Full component theory-based intervention
full active intervention Targeted beliefs + knowledge + importance
Multiple component intervention based in the unified theory of behavior
(Active Comparator)
Partial intervention. (full intervention minus the cultural-specific component)
active control Non-targeted beliefs + knowledge + importance
Partial intervention (full intervention minus cultural-specific component)
(No Intervention)
Clinic standard of care

Primary Outcomes

Adherence to initial follow-up (yes/no), delay in care, completeness of care
time frame: as clinically recommended / 1 year chart follow-up

Secondary Outcomes

patient anxiety and distress
time frame: + 7-30 days post-intervention

Eligibility Criteria

Female participants from 18 years up to 55 years old.

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.

Additional Information

Official title Intervention to Improve Follow-up of Abnormal Pap Test
Principal investigator Carmen R Breitkopf, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by The University of Texas, Galveston.