Facilitating Follow-Up Adherence for Abnormal Pap Smears
TC3
2 other identifiers
interventional
211
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2005
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 20, 2012
CompletedFirst Posted
Study publicly available on registry
March 23, 2012
CompletedMarch 23, 2012
March 1, 2012
6.1 years
March 20, 2012
March 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1-week Post-Colposcopy
Secondary Outcomes (1)
Adherence to long-term follow-up medical recommendations
9- and 15-months post-index appointment
Study Arms (3)
Cognitive-affective barriers counseling delivered by phone
EXPERIMENTALStandard care plus cognitive-affective barriers counseling delivered by phone , i.e., culturally-relevant/sensitive barrier-specific messages drawn from a pre-developed library designed to counsel individuals regarding their specific barriers to adherence
cognitive-affective barriers counseling via brochure
EXPERIMENTALStandard care plus cognitive-affective barriers counseling delivered via mail-home print material
standard care
ACTIVE COMPARATORCognitive-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
Interventions
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
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fox Chase Cancer Centerlead
- Temple Universitycollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suzanne M. Miller-Halegoua, Ph.D.
Fox Chase Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2012
First Posted
March 23, 2012
Study Start
May 1, 2005
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
March 23, 2012
Record last verified: 2012-03