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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
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), March 2009
First Received: March 31, 2009   No Changes Posted
Sponsors and Collaborators: Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00873288
  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/Nonmalignant Condition
Other: informational intervention
Other: questionnaire administration

Study Type: Interventional
Study Design: Health Services Research, Randomized, Active Control
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
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

Study ID Numbers: CDR0000626557, NU-1719-007
Study First Received: March 31, 2009
Last Updated: March 31, 2009
ClinicalTrials.gov Identifier: NCT00873288     History of Changes
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

Study placed in the following topic categories:
Precancerous Conditions
Cervical Intraepithelial Neoplasia

Additional relevant MeSH terms:
Neoplasms
Precancerous Conditions

ClinicalTrials.gov processed this record on September 02, 2009