Activating Collaborative CIS Support Via Targeted Provider Mailing
Primary Purpose
Precancerous Condition
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual care mailing intervention
CIS support mailing intervention
Sponsored by
About this trial
This is an interventional health services research trial for Precancerous Condition focused on measuring cervical intraepithelial neoplasia, atypical squamous cells of undetermined significance, high-grade squamous intraepithelial lesion, low-grade squamous intraepithelial lesion
Eligibility 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:
- Able to communicate in either English or Spanish
- Clinic staff will review patient charts to determine eligibility
PRIOR CONCURRENT THERAPY:
- Not specified
Sites / Locations
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- Erie Family Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Usual Care mailing intervention
CIS support mailing intervention
Arm Description
routine colposcopy reminder letter mailed
Mailed reminder plus provider recommendation to call CIS and sample questions to ask
Outcomes
Primary Outcome Measures
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.
CIS Experience of Patients in Arm II and the Effect of the Intervention on Their Follow-up Colposcopy
Secondary Outcome Measures
Attendance at a Follow-up Colposcopy Appointment Within 6 Months of Their Pap Test
Latency Between the Pap Test and the Colposcopy Appointment
Number of CIS Callers Who Provided the Specific Codes Listed in the Intervention Letter
Full Information
NCT ID
NCT00873288
First Posted
March 31, 2009
Last Updated
March 17, 2023
Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00873288
Brief Title
Activating Collaborative CIS Support Via Targeted Provider Mailing
Official Title
Activating Collaborative CIS Support Via Targeted Provider Mailing
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Precancerous Condition
Keywords
cervical intraepithelial neoplasia, atypical squamous cells of undetermined significance, high-grade squamous intraepithelial lesion, low-grade squamous intraepithelial lesion
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
254 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care mailing intervention
Arm Type
Active Comparator
Arm Description
routine colposcopy reminder letter mailed
Arm Title
CIS support mailing intervention
Arm Type
Experimental
Arm Description
Mailed reminder plus provider recommendation to call CIS and sample questions to ask
Intervention Type
Other
Intervention Name(s)
Usual care mailing intervention
Intervention Description
routine colposcopy reminder letter
Intervention Type
Other
Intervention Name(s)
CIS support mailing intervention
Intervention Description
Mailed reminder plus provider recommendation to call CIS and sample questions to ask
Primary Outcome Measure Information:
Title
Patient Satisfaction in the 2 Interventions
Description
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.
Time Frame
within 6 months of PAP
Title
CIS Experience of Patients in Arm II and the Effect of the Intervention on Their Follow-up Colposcopy
Time Frame
within 6 months of PAP
Secondary Outcome Measure Information:
Title
Attendance at a Follow-up Colposcopy Appointment Within 6 Months of Their Pap Test
Time Frame
within 6 months of PAP
Title
Latency Between the Pap Test and the Colposcopy Appointment
Time Frame
within 6 months of PAP
Title
Number of CIS Callers Who Provided the Specific Codes Listed in the Intervention Letter
Time Frame
WITHIN 6 MONTHS OF PAP
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bonnie Spring, PhD
Organizational Affiliation
Robert H. Lurie Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
Facility Name
Erie Family Health Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60622
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19951443
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.
Results Reference
background
PubMed Identifier
20060255
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.
Results Reference
background
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Activating Collaborative CIS Support Via Targeted Provider Mailing
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