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OpenTrials
Completed

NCT Number: NCT00873288

Activating Collaborative CIS Support Via Targeted Provider Mailing

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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:

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

PRIOR CONCURRENT THERAPY:

  • Not specified

Exclusion criteria

  • <18 years
  • unable to communicate in English or Spanish
  • no address to which a letter can be mailed

Treatment and study plan

Usual care mailing intervention

Other

routine colposcopy reminder letter

CIS support mailing intervention

Other

Mailed reminder plus provider recommendation to call CIS and sample questions to ask

Primary outcomes

  1. Patient Satisfaction in the 2 Interventions

    Time frame: within 6 months of PAP

    Patient satisfaction with provider-patient communication was assessed via administration of the Consumer Assessment of Health Plans Study (CAHPS) satisfaction questionnaire which rates satisfaction on a 1 to 3 scale. Scores are added together, with minimum score being 4 and the maximum score being 12, with a higher score indicating greater satisfaction.

  2. CIS Experience of Patients in Arm II and the Effect of the Intervention on Their Follow-up Colposcopy

    Time frame: within 6 months of PAP

Secondary outcomes

  1. Attendance at a Follow-up Colposcopy Appointment Within 6 Months of Their Pap Test

    Time frame: within 6 months of PAP

  2. Latency Between the Pap Test and the Colposcopy Appointment

    Time frame: within 6 months of PAP

  3. Number of CIS Callers Who Provided the Specific Codes Listed in the Intervention Letter

    Time frame: WITHIN 6 MONTHS OF PAP

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Apr 1, 2009
Registry last updated
Mar 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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