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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00873288
First received: March 31, 2009
Last updated: January 27, 2010
Last verified: March 2009
  Purpose

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 Intervention
Precancerous Condition
Other: informational intervention
Other: questionnaire administration

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Health Services Research
Official Title: Activating Collaborative CIS Support Via Targeted Provider Mailing

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Patient satisfaction in the 2 interventions [ Designated as safety issue: No ]
  • CIS experience of patients in arm II and the effect of the intervention on their follow-up colposcopy [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Attendance at a follow-up colposcopy appointment within 6 months of their Pap test [ Designated as safety issue: No ]
  • Latency between the Pap test and the colposcopy appointment [ Designated as safety issue: No ]
  • Number of CIS callers who provided the specific codes listed in the intervention letter [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: October 2006
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

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

PRIOR CONCURRENT THERAPY:

  • Not specified
  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: NCT00873288

Locations
United States, Illinois
Erie Family Health Center Recruiting
Chicago, Illinois, United States, 60622
Contact: Contact Person    Not Available    bspring@northwestern.edu   
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   
Sponsors and Collaborators
Robert H. Lurie Cancer Center
Investigators
Principal Investigator: Bonnie Spring, PhD Robert H. Lurie Cancer Center
  More Information

Additional Information:
No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00873288     History of Changes
Other Study ID Numbers: CDR0000626557, NU-1719-007
Study First Received: March 31, 2009
Last Updated: January 27, 2010
Health Authority: Unspecified

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
Neoplasms

ClinicalTrials.gov processed this record on August 19, 2014