Activating Collaborative CIS Support Via Targeted Provider Mailing

NCT00873288 | Completed Results

• 4 other identifiers: CDR0000626557P30CA060553NU-1719-007R21CA126450
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 2

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.

Conditions

Precancerous Condition

Keywords

cervical intraepithelial neoplasia; atypical squamous cells of undetermined significance; high-grade squamous intraepithelial lesion; low-grade squamous intraepithelial lesion

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (2)

Usual Care mailing intervention

ACTIVE COMPARATOR

routine colposcopy reminder letter mailed

Other: Usual care mailing intervention

CIS support mailing intervention

EXPERIMENTAL

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

Other: CIS support mailing intervention

Interventions

Usual care mailing intervention OTHER

routine colposcopy reminder letter

Usual Care mailing intervention

CIS support mailing intervention OTHER

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

CIS support mailing intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<18 years
• unable to communicate in English or Spanish
• no address to which a letter can be mailed

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Erie Family Health Center

Chicago, Illinois, 60622, United States

Location

Related 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.

  PMID: 19951443 BACKGROUND

• 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.

  PMID: 20060255 BACKGROUND

MeSH Terms

Conditions

Precancerous Conditions; Uterine Cervical Dysplasia; Atypical Squamous Cells of the Cervix; Squamous Intraepithelial Lesions

Condition Hierarchy (Ancestors)

Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Bonnie Spring
• Organization: Northwestern University

bspring@northwestern.edu

312-908-2293

Study Officials

• Bonnie Spring, PhD

  Robert H. Lurie Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Behavior and Health

Study Record Dates

• First Submitted: March 31, 2009
• First Posted: April 1, 2009
• Study Start: October 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: March 21, 2023
• Results First Posted: March 20, 2023

Record last verified: 2023-03

Locations

US (2)