Activating Collaborative CIS Support Via Targeted Provider Mailing

Precancerous Condition Clinical Trial

Official title:

Activating Collaborative CIS Support Via Targeted Provider Mailing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00873288
• Other study ID #: CDR0000626557
• Secondary ID: P30CA060553NU-17
• Status: Completed
• Phase: N/A
• Start date: October 2006
• Est. completion date: November 2008

Study information

• Verified date: March 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Precancerous Condition
• Precancerous Conditions

Intervention

Other:
• Usual care mailing intervention
routine colposcopy reminder letter
• CIS support mailing intervention
Mailed reminder plus provider recommendation to call CIS and sample questions to ask

Locations

Country	Name	City	State
United States	Erie Family Health Center	Chicago	Illinois
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	CIS Experience of Patients in Arm II and the Effect of the Intervention on Their Follow-up Colposcopy		within 6 months of PAP
Secondary	Attendance at a Follow-up Colposcopy Appointment Within 6 Months of Their Pap Test		within 6 months of PAP
Secondary	Latency Between the Pap Test and the Colposcopy Appointment		within 6 months of PAP
Secondary	Number of CIS Callers Who Provided the Specific Codes Listed in the Intervention Letter		WITHIN 6 MONTHS OF PAP