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Facilitating Follow-Up Adherence for Abnormal Pap Smears

NCT01561326CompletedNAINTERVENTIONAL

Summary

Objective: Previous studies have suggested that psycho-educational interventions delivered by telephone improve adherence to initial colposcopy after an abnormal Pap smear. To further explore strategies for enhanced follow-up to medical care recommendations, we studied the impact of a theory-guided cognitive-affective barriers counseling intervention, delivered at 2-4 weeks before the colposcopy appointment, for inner city women. The comprehensive telephone barriers intervention was compared to an enhanced comparison group and a group that received tailored print materials. Methods: Participants (N = 211) were recruited through a colposcopy clinic and randomly assigned to: 1) telephone assessment of barriers to follow up adherence recommendations combined with tailored telephone barriers counseling; 2) telephone assessment combined with tailored barriers print brochure; or 3) telephone assessment with no barriers counseling. Participants were assessed at baseline, 1-week, 9 and 15 months post-colposcopy.

Key Facts

Lead Sponsor

Fox Chase Cancer Center

Enrollment

211

Start Date

2005-05-01

Completion Date

2011-06-01

Study Type

INTERVENTIONAL

Official Title

Facilitating Follow-Up Adherence for Abnormal Pap Smears

Interventions

Cognitive-affective barriers counselingCognitive-affective barriers counseling via brochurestandard care

Conditions

Uterine Cervical Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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
* HIV

Outcome Measures

Primary Outcomes

Adherence to diagnostic colposcopy appointment

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.

Time frame: 1-week Post-Colposcopy

Secondary Outcomes

Adherence to long-term follow-up medical recommendations

Adherence to 6- and 12-months colposcopically-directed recommendations and medical management over time will be assessed through medical chart review, as well as self-report, at 9- and 15-months post-index appointment. A 3-month grace period was selected to accommodate any clinic-based rescheduling and/or cancellation of appointments for procedures.

Time frame: 9- and 15-months post-index appointment

Locations

Fox Chase Cancer Center, Philadelphia, United States

Linked Diseases

Uterine Cervical Neoplasms

Uterine Cervical Neoplasms — a type of gynecological cancer.