Intervention to Improve Follow-up of Abnormal Pap Test
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

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.
    

Intervention name(s): Intervention; Active control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Multiple component intervention based in the unified theory of behavior; Partial intervention (full intervention minus cultural-specific component)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: unified theory of behavior; Pap test; cervical dysplasia; women's health