Intervention to Improve Follow-up of Abnormal Pap Test

NCT ID: NCT00575510

Last Updated: 2018-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 341 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2012-04-30

Brief Summary

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.

Detailed 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.

Conditions

Cervical Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Intervention

Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling

Group Type: EXPERIMENTAL

Intervention

Intervention Type: BEHAVIORAL

Multiple component intervention based in the unified theory of behavior

Active Control

nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling

Group Type: ACTIVE_COMPARATOR

Active control

Intervention Type: BEHAVIORAL

Partial intervention (full intervention minus cultural-specific component)

Standard Care Only

Clinical standard of care at time of study

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intervention

Multiple component intervention based in the unified theory of behavior

Intervention Type: BEHAVIORAL

Active control

Partial intervention (full intervention minus cultural-specific component)

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carmen R Breitkopf, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Medical Branch, Galveston

Locations

University of Texas Medical Branch

Galveston, Texas, United States

Countries

United States

References

Breitkopf CR, Dawson L, Grady JJ, Breitkopf DM, Nelson-Becker C, Snyder RR. Intervention to improve follow-up for abnormal Papanicolaou tests: a randomized clinical trial. Health Psychol. 2014 Apr;33(4):307-316. doi: 10.1037/a0032722. Epub 2013 Jun 3.

Reference Type: RESULT

PMID: 23730719 (View on PubMed)

Other Identifiers

R01CA107015

Identifier Type: NIH

Identifier Source: secondary_id

View Link

05-245

Identifier Type: -

Identifier Source: org_study_id