Facilitating Follow-Up Adherence for Abnormal Pap Smears
NCT01561326 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 211
Last updated 2012-03-23
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.
Conditions
- Uterine Cervical Neoplasms
Interventions
- BEHAVIORAL
-
Cognitive-affective barriers counseling
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
- BEHAVIORAL
-
Cognitive-affective barriers counseling via brochure
Culturally-relevant/sensitive barrier-specific messages drawn from a pre-developed library designed to counsel individuals regarding their specific barriers to adherence via brochure, 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
- BEHAVIORAL
-
standard care
Cognitive-affective barriers (CAB) assessment delivered via phone; receipt of a notification letter from physician regarding abnormal Pap test result, need to undergo colposcopy, appointment date and clinic contact numbers; telephone confirmation and post-card appointment reminder
Sponsors & Collaborators
-
Temple University
collaborator OTHER -
National Cancer Institute (NCI)
collaborator NIH -
Fox Chase Cancer Center
lead OTHER
Principal Investigators
-
Suzanne M. Miller-Halegoua, Ph.D. · Fox Chase Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-05-31
- Primary Completion
- 2011-06-30
- Completion
- 2011-06-30
Countries
- United States
Study Locations
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