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.

Study Overview

• Status: Completed
• Conditions: Precancerous Condition
• Intervention / Treatment: Other: Usual care mailing intervention; Other: CIS support mailing intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 254
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611-3013
      • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
    • Chicago, Illinois, United States, 60622
      • Erie Family Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care mailing intervention; routine colposcopy reminder letter mailed	Other: Usual care mailing intervention; routine colposcopy reminder letter
Experimental: CIS support mailing intervention; Mailed reminder plus provider recommendation to call CIS and sample questions to ask	Other: CIS support mailing intervention; Mailed reminder plus provider recommendation to call CIS and sample questions to ask

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction in the 2 Interventions	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.	within 6 months of PAP
CIS Experience of Patients in Arm II and the Effect of the Intervention on Their Follow-up Colposcopy		within 6 months of PAP

Secondary Outcome Measures

Outcome Measure	Time Frame
Attendance at a Follow-up Colposcopy Appointment Within 6 Months of Their Pap Test	within 6 months of PAP
Latency Between the Pap Test and the Colposcopy Appointment	within 6 months of PAP
Number of CIS Callers Who Provided the Specific Codes Listed in the Intervention Letter	WITHIN 6 MONTHS OF PAP

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Bonnie Spring, PhD, Robert H. Lurie Cancer Center

Publications and helpful links

General Publications

• Cofta-Woerpel L, Randhawa V, McFadden HG, Fought A, Bullard E, Spring B. ACCISS study rationale and design: activating collaborative cancer information service support for cervical cancer screening. BMC Public Health. 2009 Dec 2;9:444. doi: 10.1186/1471-2458-9-444.
• Simon MA, Cofta-Woerpel L, Randhawa V, John P, Makoul G, Spring B. Using the word 'cancer' in communication about an abnormal Pap test: finding common ground with patient-provider communication. Patient Educ Couns. 2010 Oct;81(1):106-12. doi: 10.1016/j.pec.2009.11.022. Epub 2010 Jan 8.

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: March 31, 2009
• First Submitted That Met QC Criteria: March 31, 2009
• First Posted (Estimate): April 1, 2009

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: cervical intraepithelial neoplasia; low-grade squamous intraepithelial lesion; atypical squamous cells of undetermined significance; high-grade squamous intraepithelial lesion
• Additional Relevant MeSH Terms: Neoplasms; Precancerous Conditions
• Other Study ID Numbers: CDR0000626557; P30CA060553 (U.S. NIH Grant/Contract); NU-1719-007 (Other Identifier: Northwestern University); R21CA126450 (U.S. NIH Grant/Contract)