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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA060553 | U.S. NIH Grant/Contract | View source | |
| NU-1719-007 | Other Identifier | Northwestern University | |
| R21CA126450 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 intervention arms.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care mailing intervention | Active Comparator | routine colposcopy reminder letter mailed |
|
| CIS support mailing intervention | Experimental | Mailed reminder plus provider recommendation to call CIS and sample questions to ask |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual care mailing intervention | Other | routine colposcopy reminder letter |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion criteria:
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bonnie Spring, PhD | Robert H. Lurie Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | 60611-3013 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19951443 | Background | 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. | |
| 20060255 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care Mailing Intervention | routine colposcopy reminder letter mailed |
| FG001 | CIS Support Mailing Intervention | Mailed reminder plus provider recommendation to call CIS and sample questions to ask |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care Mailing Intervention | routine colposcopy reminder letter mailed |
| BG001 | CIS Support Mailing Intervention | Mailed reminder plus provider recommendation to call CIS and sample questions to ask |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | within 6 months of PAP |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care Mailing Intervention | routine colposcopy reminder letter mailed |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bonnie Spring | Northwestern University | 312-908-2293 | bspring@northwestern.edu |
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| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D002578 | Uterine Cervical Dysplasia |
| D065309 | Atypical Squamous Cells of the Cervix |
| D000081483 | Squamous Intraepithelial Lesions |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
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| CIS support mailing intervention | Other | Mailed reminder plus provider recommendation to call CIS and sample questions to ask |
|
| Number of CIS Callers Who Provided the Specific Codes Listed in the Intervention Letter |
| WITHIN 6 MONTHS OF PAP |
| Erie Family Health Center |
| Chicago |
| Illinois |
| 60622 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | CIS Experience of Patients in Arm II and the Effect of the Intervention on Their Follow-up Colposcopy | The apparatus that Boeing built to identify which CIS callers were from the study did not function correctly. Therefore, we could not determine whether participants called CIS or not. | Posted | within 6 months of PAP |
|
|
| Secondary | Attendance at a Follow-up Colposcopy Appointment Within 6 Months of Their Pap Test | Posted | Count of Participants | Participants | within 6 months of PAP |
|
|
|
|
| Secondary | Latency Between the Pap Test and the Colposcopy Appointment | Posted | Mean | 95% Confidence Interval | days | within 6 months of PAP |
|
|
|
|
| Secondary | Number of CIS Callers Who Provided the Specific Codes Listed in the Intervention Letter | The apparatus that Boeing built to identify which CIS callers were from the study did not function correctly. Therefore, we could not determine whether participants called CIS or not. | Posted | WITHIN 6 MONTHS OF PAP |
|
|
| 0 |
| 127 |
| 0 |
| 127 |
| EG001 | CIS Support Mailing Intervention | Mailed reminder plus provider recommendation to call CIS and sample questions to ask | 0 | 127 | 0 | 127 |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |