Precancerous Condition
Conditions
Keywords
cervical intraepithelial neoplasia, atypical squamous cells of undetermined significance, high-grade squamous intraepithelial lesion, low-grade squamous intraepithelial lesion
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.
Interventions
OTHERUsual care mailing intervention
routine colposcopy reminder letter
OTHERCIS support mailing intervention
Mailed reminder plus provider recommendation to call CIS and sample questions to ask
Sponsors
National Cancer Institute (NCI)
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction in the 2 Interventions | within 6 months of PAP | 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 | within 6 months of PAP | — |
Secondary
| Measure | 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 |
| Number of CIS Callers Who Provided the Specific Codes Listed in the Intervention Letter | WITHIN 6 MONTHS OF PAP |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Mailing Intervention routine colposcopy reminder letter mailed | 127 |
| CIS Support Mailing Intervention Mailed reminder plus provider recommendation to call CIS and sample questions to ask | 127 |
| Total | 254 |
Baseline characteristics
| Characteristic | CIS Support Mailing Intervention | Usual Care Mailing Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 127 Participants | 127 Participants | 254 Participants |
| Age, Continuous | 27.8 years STANDARD_DEVIATION 9.3 | 28.1 years STANDARD_DEVIATION 9.1 | 27.95 years STANDARD_DEVIATION 9.2 |
| Region of Enrollment United States | 127 participants | 127 participants | 254 participants |
| Sex: Female, Male Female | 127 Participants | 127 Participants | 254 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 127 | 0 / 127 |
| serious Total, serious adverse events | 0 / 127 | 0 / 127 |
Outcome results
Primary
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
Population: 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.
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.
Time frame: within 6 months of PAP
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Mailing Intervention | Patient Satisfaction in the 2 Interventions | 11.79 score on a scale | Standard Deviation 0.563 |
| CIS Support Mailing Intervention | Patient Satisfaction in the 2 Interventions | 11.68 score on a scale | Standard Deviation 0.912 |
p-value: >0.05t-test, 2 sided
Secondary
Attendance at a Follow-up Colposcopy Appointment Within 6 Months of Their Pap Test
Time frame: within 6 months of PAP
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Mailing Intervention | Attendance at a Follow-up Colposcopy Appointment Within 6 Months of Their Pap Test | 107 Participants |
| CIS Support Mailing Intervention | Attendance at a Follow-up Colposcopy Appointment Within 6 Months of Their Pap Test | 102 Participants |
p-value: 0.207Chi-squared
Secondary
Latency Between the Pap Test and the Colposcopy Appointment
Time frame: within 6 months of PAP
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care Mailing Intervention | Latency Between the Pap Test and the Colposcopy Appointment | 39.5 days |
| CIS Support Mailing Intervention | Latency Between the Pap Test and the Colposcopy Appointment | 42.5 days |
p-value: 0.66t-test, 2 sided
Secondary
Number of CIS Callers Who Provided the Specific Codes Listed in the Intervention Letter
Time frame: WITHIN 6 MONTHS OF PAP
Population: 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.