Facilitating Follow-Up Adherence for Abnormal Pap Smears (TC3)

This study has been completed.
Sponsor:
Collaborators:
Temple University
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT01561326
First received: March 20, 2012
Last updated: March 21, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Uterine Cervical Neoplasms
Behavioral: Cognitive-affective barriers counseling
Behavioral: Cognitive-affective barriers counseling via brochure
Behavioral: standard care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Facilitating Follow-Up Adherence for Abnormal Pap Smears

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Primary Outcome Measures:
  • Adherence to diagnostic colposcopy appointment [ Time Frame: 1-week Post-Colposcopy ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Adherence to long-term follow-up medical recommendations [ Time Frame: 9- and 15-months post-index appointment ] [ Designated as safety issue: No ]
    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.


Enrollment: 211
Study Start Date: May 2005
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive-affective barriers counseling delivered by phone
Standard 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
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
Experimental: cognitive-affective barriers counseling via brochure
Standard care plus cognitive-affective barriers counseling delivered via mail-home print material
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
Active Comparator: 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
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561326

Locations
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Fox Chase Cancer Center
Temple University
Investigators
Principal Investigator: Suzanne M. Miller-Halegoua, Ph.D. Fox Chase Cancer Center
  More Information

No publications provided

Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT01561326     History of Changes
Other Study ID Numbers: IRB04802, R01CA104979
Study First Received: March 20, 2012
Last Updated: March 21, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Fox Chase Cancer Center:
cervical cancer
follow-up
Pap test
Medical management
Colposcopy

Additional relevant MeSH terms:
Neoplasms
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 24, 2014