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Personalized Letter With Cancer Information Service Support or a Standard Reminder Letter in Women Scheduled for Colposcopy After an Abnormal Pap Test

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ClinicalTrials.gov Identifier: NCT00873288
Recruitment Status : Unknown
Verified March 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : April 1, 2009
Last Update Posted : January 28, 2010
Information provided by:

Study Description
Brief Summary:

RATIONALE: Receiving a reminder letter from their doctor with questions to ask the Cancer Information Service may be more effective than a standard reminder letter in helping patients who have had an abnormal Pap test keep their follow-up colposcopy appointment.

PURPOSE: This randomized clinical trial is studying a personalized letter with Cancer Information Service support to see how well it works compared with a standard reminder letter in women scheduled for colposcopy after an abnormal Pap test.

Condition or disease Intervention/treatment
Precancerous Condition Other: informational intervention Other: questionnaire administration

Detailed Description:


  • Compare the effect of a usual care mailing intervention vs a Cancer Information Service (CIS) support mailing intervention on the likelihood that women with an abnormal Pap test will keep their medical follow-up appointments and be satisfied with how they talk to their provider.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 intervention arms.

  • Arm I (Usual-care mailing intervention): Patients receive a generic letter reminding them of their follow-up colposcopy appointment.
  • Arm II (Cancer Information Service [CIS] support mailing intervention): Patients receive a targeted letter reminding them of their follow-up colposcopy appointment, asking them or someone they designate to call the CIS, and suggesting some questions to ask the CIS about colposcopies and Pap tests.

At their follow-up appointments, all patients undergo an exit interview to compare patient satisfaction between the 2 interventions. Patients in arm II also answer questions about their CIS experience, and if the intervention made their follow-up visit less difficult.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Primary Purpose: Health Services Research
Official Title: Activating Collaborative CIS Support Via Targeted Provider Mailing
Study Start Date : October 2006
Estimated Primary Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Patient satisfaction in the 2 interventions
  2. CIS experience of patients in arm II and the effect of the intervention on their follow-up colposcopy

Secondary Outcome Measures :
  1. Attendance at a follow-up colposcopy appointment within 6 months of their Pap test
  2. Latency between the Pap test and the colposcopy appointment
  3. Number of CIS callers who provided the specific codes listed in the intervention letter

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Received an abnormal Pap test result
  • Scheduled for a colposcopy within 6 months of their Pap test at either the Erie Family Health Center or the Prentice Ambulatory Clinic


  • Able to communicate in either English or Spanish
  • Clinic staff will review patient charts to determine eligibility


  • Not specified
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00873288

United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Recruiting
Chicago, Illinois, United States, 60611-3013
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer    312-695-1301    cancer@northwestern.edu   
Erie Family Health Center Recruiting
Chicago, Illinois, United States, 60622
Contact: Contact Person    Not Available    bspring@northwestern.edu   
Sponsors and Collaborators
Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Bonnie Spring, PhD Robert H. Lurie Cancer Center
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00873288     History of Changes
Other Study ID Numbers: CDR0000626557
First Posted: April 1, 2009    Key Record Dates
Last Update Posted: January 28, 2010
Last Verified: March 2009

Keywords provided by National Cancer Institute (NCI):
cervical intraepithelial neoplasia
atypical squamous cells of undetermined significance
high-grade squamous intraepithelial lesion
low-grade squamous intraepithelial lesion

Additional relevant MeSH terms:
Precancerous Conditions