Activating Collaborative CIS Support Via Targeted Provider Mailing

Northwestern University

Status: Completed

Conditions: Precancerous Condition

Treatments: Other: Usual care mailing intervention; Other: CIS support mailing intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00873288

R21CA126450 (U.S. NIH Grant/Contract)

CDR0000626557

P30CA060553 (U.S. NIH Grant/Contract)

NU-1719-007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 254 patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

254 participants in 2 patient groups

Usual Care mailing intervention

Active Comparator group

Description:

routine colposcopy reminder letter mailed

Treatment:

Other: Usual care mailing intervention

CIS support mailing intervention

Experimental group

Description:

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

Treatment:

Other: CIS support mailing intervention