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Facilitating Follow-Up Adherence for Abnormal Pap Smears

18 Years
Not Enrolling
Uterine Cervical Neoplasms

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Trial Information

Facilitating Follow-Up Adherence for Abnormal Pap Smears

Objective: Previous studies have shown that theory-based, tailored telephone barriers
counseling significantly improves adherence to a colposcopy appointment after an abnormal
pap smear result among low-income, minority women. This study built on these research
findings and explored the efficacy of a state-of-the-science telephone counseling
intervention utilizing a more rigorous study design. This enhanced counseling intervention
was tailored to individual's distinctive cognitive-affective barriers profile, as assessed
by the Cognitive-Social Health Information Processing (C-SHIP) model-guided barriers
assessment tool, and with counseling messages targeted to all five domains of individual's
barriers to adherence. In addition, the current study design was improved in two ways.
First, the comparison group in this current study was an enhanced one that received a
notification letter, assessment of cognitive-affective barriers by telephone, and a
telephone appointment reminder. Second, this study had a longer follow-up period to allow
testing of the intervention effect beyond initial colposcopy adherence. The participants
were followed for 15 months post-colposcopy so that participants' adherence to medical
follow-up recommendations (if any) within the 12 months after initial colposcopy can be
collected and studied. Adherence to medical follow-up at 6 months and 12 months was measured
at 9 months and 15 months, respectively, to allow 3 months for rescheduling, attending, and
recording of the appointment. Overall, this study tested whether an enhanced tailored
telephone barriers counseling intervention improve adherence to medical follow-up after
abnormal pap smear among low-income, minority women.


METHODS Participants (211) were randomized to the following baseline conditions: a) standard
care (SC), i.e., a cognitive-affective barriers (CAB) assessment delivered via phone,
receipt of a notification letter from physician regarding abnormal Pap test result and need
to undergo colposcopy, and also including appointment date and clinic contact numbers, plus
telephone confirmation and post-card appointment reminder; b) SC plus CAB counseling
delivered by phone (CAB-C -T), i.e., culturally-relevant/sensitive barrier-specific messages
drawn from a pre-developed library designed to counsel individuals regarding their specific
barriers to adherence, e.g., by increasing risk-related knowledge, providing accurate
outcome and self-efficacy expectancies, addressing health-related values and goals,
moderating risk-related affect, or offering active plans and strategies to assist with
self-regulation; c) SC plus CAB counseling delivered via Mail-Home Print Material (CAB-C-P),
which included exactly the same applicable messages as were delivered by phone, but in print
form. The tailoring of messages to a participant's cognitive-affective barriers profile was
based on the two barriers in each of the five Cognitive-Social Health Information Processing
(C-SHIP) categories (a total of 10 messages) that she rated most important on a five-point
scale. There were 23 cognitive-affective adherence barriers grouped into the following
C-SHIP categories: 1) risk-related encodings/perceptions (i.e., purpose of colposcopy,
presence and progression of HPV-related disease); 2) risk-related expectancies and beliefs
(i.e., confidence in ability to keep appointment, fatalistic beliefs about cancer); 3)
risk-related values and goals (i.e., maintaining modesty, importance of having children);
4) risk-related affect (i.e., worries about necessary procedures and/or progression of
disease, concerns regarding fertility); and 5) risk-related self-regulation (i.e.,
remembering appointment, overcoming child-care or work-related conflicts, transportation
difficulties, ability to manage any negative risk-related affect). With regard to
assessments, they were conducted at the following time points: baseline, and 1-week,
9-month, and 15-month post-colposcopy and included the following: the CAB assessment;
background variables, including demographic (e.g., gender, age, ethnicity, education,
marital and employment status, household income, number of children); medical and screening
history (e.g., cancer diagnosis, previous Pap smears and frequency; breast exams (self and
clinical); mammograms and abnormal results; results of the index colposcopy and physician
recommendations from medical records; a potential moderating dispositional variable,
attentional style (Monitoring-Blunting Style Scale); potential mediating variables,
including affective variables (Spielberger State-Trait Anxiety Inventory, the Center for
Epidemiological Studies-Depression Scale), and cognitive-affective process variables
(knowledge, risk perceptions, expectancies and beliefs, affect, values and goals, regulatory
skills); outcome variables, including adherence to initial diagnostic colposcopy and to 6-
and 12-months colposcopically-based follow-up diagnostic and medical management
recommendations, and an intervention evaluation. All assessments used scales developed in
previous research, except the Powe Fatalism Inventory used to assess fatalism and the
Revised Impact of Events Scale used to assess affect (i.e., stress-related intrusive and
avoidant thoughts). Assessed at baseline were background variables (except medical
recommendations), the moderating variable, and all mediating variables. The
cognitive-affective barriers were assessed only at baseline. Assessed at 1-week
post-colposcopy and at the 9-month and 15 month follow-ups were all mediating variables
(except the cognitive-affect barriers) and outcome variables. The medical recommendations
were assessed only at the 1-week post-colposcopy. Medical history was also re-assessed at
the 15-month follow-up relating to the interim period from baseline.

Inclusion Criteria:

- women 18 years old or older

- have recently received an abnormal Pap smear indicative of oncogenic HPV

- have been referred for initial colposcopic evaluation at the Women's Care Center at
Temple University Hospital

- able to communicate with ease in English

Exclusion Criteria:

- unable to communicate readily in English

- do not have access to a telephone

- have a history of any malignancy

- display current evidence of positive invasive carcinoma of the cervix

- display presence of another life-threatening medical condition

- show evidence of dementia

- prior participation in research study


Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Adherence to diagnostic colposcopy appointment

Outcome Description:

Adherence to initial diagnostic colposcopy will be assessed for each participant through tracking of clinic reports/patient medical records immediately post-colposcopy. Adherence will be measured dichotomously with patients who attend their initial appointment or who cancel their initial colposcopy appointment but reschedule within one month of their original date deemed adherent and eligible for follow-up assessments.

Outcome Time Frame:

1-week Post-Colposcopy

Safety Issue:


Principal Investigator

Suzanne M. Miller-Halegoua, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

May 2005

Completion Date:

June 2011

Related Keywords:

  • Uterine Cervical Neoplasms
  • cervical cancer
  • follow-up
  • Pap test
  • Medical management
  • Colposcopy
  • Neoplasms
  • Uterine Cervical Neoplasms



Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111