Activating Collaborative CIS Support Via Targeted Provider Mailing

NCT ID: NCT00873288

Last Updated: 2023-03-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

254 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-11-30

Brief Summary

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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

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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.

Conditions

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Precancerous Condition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Usual Care mailing intervention

routine colposcopy reminder letter mailed

Group Type ACTIVE_COMPARATOR

Usual care mailing intervention

Intervention Type OTHER

routine colposcopy reminder letter

CIS support mailing intervention

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

Group Type EXPERIMENTAL

CIS support mailing intervention

Intervention Type OTHER

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

Interventions

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Usual care mailing intervention

routine colposcopy reminder letter

Intervention Type OTHER

CIS support mailing intervention

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Bonnie Spring

Director, Center for Behavior and Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bonnie Spring, PhD

Role: PRINCIPAL_INVESTIGATOR

Robert H. Lurie Cancer Center

Locations

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Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

Site Status

Erie Family Health Center

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19951443 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20060255 (View on PubMed)

Other Identifiers

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P30CA060553

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NU-1719-007

Identifier Type: OTHER

Identifier Source: secondary_id

R21CA126450

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000626557

Identifier Type: -

Identifier Source: org_study_id

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