Intervention to improve follow-up for abnormal Papanicolaou tests: a randomized clinical trial.

The rate of cervical cancer has not changed in the U.S. since 2003 (ACS, 2011). In the year 2011, the incidence of cervical cancer was 12,710 and over 4,200 women died from a preventable cancer (ACS, 2011). In most cases, regular Papanicolaou (Pap) screening and adherence to treatment or monitoring of precursor lesions can prevent cervical cancer (Lawson, Henson, Bobo, & Kaeser, 2000). Unfortunately, 20–70% of women in the U.S. who experience an abnormal Pap test do not adhere to recommended follow-up (Marcus et al., 1992; Michielutte, Dignan, Bahnson, & Wells, 1994; Paskett, White, Carter, & Chu, 1990; Peterson, Han, & Freund, 2003). Behavioral approaches that improve adherence have been identified as a priority for cervical cancer prevention efforts (NIH, 1998). Approaches that target low-income and minority women are especially important, as socioeconomically disadvantaged and minority women bear a disproportionate burden of cervical cancer morbidity and mortality (ACS, 2011; Howlader et al., 2011). These disparities appear to reflect more advanced disease upon screening (Downs, Smith, Scarinci, Flowers, & Parham, 2008) and poorer adherence to follow-up (Benard, Lawson, Eheman, Anderson, & Helsel, 2005; Benard, Lee, Piper, & Richardson, 2001) rather than lower screening rates among minorities (National Center for Health Statistics, 2009). This study evaluated an intervention to improve adherence to follow-up for abnormal Pap test results among minority women and women of lower socioeconomic status. The intervention was a message, delivered verbally to patients at the time of notification of an abnormal Pap test result. The content of the intervention was guided by a unifying theory of behavior (Jaccard, Litardo, & Wan, 1999) which captures the major components of the theory of reasoned action (Fishbein & Ajzen, 1975), planned behavior (Ajzen, 1985), social learning theory (Bandura, 1986), and subjective culture (Triandis, Vassiliou, Vassiliou, Tanaka, & Shanmugam, 1972). Prior research has described how women represent many of these theoretical constructs when considering follow-up of an abnormal Pap test result (Breitkopf, Catero, Jaccard & Berenson, 2004). Furthermore, several investigations have established relationships between attending follow-up for abnormal Pap test results and constructs such as attitudes, beliefs (Radecki Breitkopf & Pearson, 2009) and knowledge (Breitkopf, Pearson, & Breitkopf, 2005; Stewart, Buchegger, Lickrish, & Sierra, 1994). Importantly, with regard to attending follow-up appointments for abnormal cervical screening tests, the content of the beliefs and their relationship to adherence has been shown to vary by race/ethnicity (Breitkopf, Catero, Jaccard, & Berenson, 2004; Radecki Breitkopf & Pearson, 2009). Such variation may underlie observed differences in adherence by race/ethnicity (Carey & Gjerdingen, 1993; Marcus et al., 1998) and should be addressed in interventions designed for minority women through targeted approaches. Finally, literature on implementation intentions and cervical screening (Sheeran & Orbell, 2000) suggests that guiding women toward highly specific intentions to return for follow-up, and including barriers counseling are important components of a behavioral intervention. The primary objective of the research was to examine whether a theory-based, multi-component intervention that included targeted beliefs for Hispanic, non-Hispanic black and non-Hispanic white women would improve attendance at follow-up among women of lower socioeconomic status who receive abnormal results upon attending cervical cancer screening. Secondary objectives included evaluating the effect of the intervention on time to adherence (delay in care) and whether resolution of the abnormality was achieved (completeness of care), as recommended by Yabroff et al. (2003). Delay in obtaining follow-up care is an important behavioral outcome, as delays can lead to more aggressive treatment at a later date, which can adversely affect patient prognosis (Nelson, Geiger, & Mangione, 2002) or psychological well-being (Lerman, Miller, Scarborough, Hanjani, Nolte, & Smith, 1991). Completeness of care, or continued adherence to recommendations for follow-up until the abnormality has been resolved is also important, yet few studies have followed women long enough to measure this outcome (Ell et al., 2002). In addition to measuring behavioral outcomes, this study considered psychological outcomes of the intervention, as abnormal Pap test results have been associated with depression and anxiety (e.g., Lerman et al., 1991; Rogstad, 2002). In a multi-site randomized clinical trial, behavioral and psychological outcomes were compared between women notified of an abnormal Pap test result in the context of a message containing information regarding knowledge/skills, importance/salience, environmental constraints, normative influences, and expectancies/beliefs about attending follow-up, as compared to women notified in the context of a non-targeted message (active control group) and passive (standard care only) control group. It was hypothesized that a greater proportion of patients randomized to the intervention would return for their initial follow-up appointment and would complete their care. Among those not attending the initial follow-up appointment, it was hypothesized that delay would be shortest in the intervention group relative to the active and passive control groups, which were not expected to differ. Depressive symptoms and distress regarding the abnormal result were not expected to differ among the study groups whereas women in the intervention group were expected to demonstrate higher anxiety upon receiving an abnormal result than women in the control groups, as the intervention message (described below) was designed to overcome potential complacency, heighten awareness of the importance of follow-up for an abnormal Pap test result, and describe potential negative consequences if left untreated, which may raise anxiety. Consistent with conceptual models of cognitive processing, an acute stressor (such as receiving an abnormal test result) and its associated arousal/anxiety are associated with heightened attention, vigilance, and message encoding (see review by Bourne & Yaroush, 2003). Thus, women who were adherent (versus non-adherent) were hypothesized to have higher levels of anxiety at the time of notification of the abnormal result.