Clinical trial NCT00873288: Activating Collaborative CIS Support Via Targeted Provider Mailing
Official title: Activating Collaborative CIS Support Via Targeted Provider Mailing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Precancerous Condition
Keywords: cervical intraepithelial neoplasia
atypical squamous cells of undetermined significance
high-grade squamous intraepithelial lesion
low-grade squamous intraepithelial lesion
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-04-01
Enrollment: 254
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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 criteria: 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

Primary outcomes:
measure: Patient Satisfaction in the 2 Interventions
timeFrame: within 6 months of PAP
measure: CIS Experience of Patients in Arm II and the Effect of the Intervention on Their Follow-up Colposcopy
timeFrame: within 6 months of PAP
Secondary outcomes:
measure: Attendance at a Follow-up Colposcopy Appointment Within 6 Months of Their Pap Test
timeFrame: within 6 months of PAP
measure: Latency Between the Pap Test and the Colposcopy Appointment
timeFrame: within 6 months of PAP
measure: Number of CIS Callers Who Provided the Specific Codes Listed in the Intervention Letter
timeFrame: WITHIN 6 MONTHS OF PAP
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center at Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Erie Family Health Center
state: Illinois
Study officials:
affiliation: Robert H. Lurie Cancer Center
name: Bonnie Spring, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.