Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00483288
Status:
COMPLETED
Last Update Posted:
2017-01-19
First Post:
2007-06-06
Brief Title:
Written Educational Information and Phone Calls in Increasing Follow-Up Care in Hispanic Women With Abnormal Pap Smears
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Wake Forest University Cervical Screening and Follow Up System for Hispanic Women - A Pilot Study
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Written educational materials and counseling by phone may help promote follow-up care in women with abnormal Pap smears
PURPOSE This clinical trial is studying how well written educational information and phone calls work in increasing follow-up care in Hispanic women with abnormal Pap smears
PURPOSE This clinical trial is studying how well written educational information and phone calls work in increasing follow-up care in Hispanic women with abnormal Pap smears
Detailed Description:
OBJECTIVES
Primary
Determine the reasons for nonadherence to follow-up in Hispanic women with abnormal Pap smear findings
Assess the effect of written educational information and phone calls on follow-up rate in these patients
OUTLINE This is a pilot cross-sectional controlled multicenter study Patients are sequentially assigned to 1 of 3 intervention groups
Group 1 control Patients complete a standardized Spanish survey questionnaire assessing their demographic information knowledge attitudes behaviors experiences with cervical screening past medical history and prior treatment either in person for those who kept their colposcopy appointment or over the telephone for those who did not keep their colposcopy appointment Additional questions are added for patients who did not keep their colposcopy appointment to test for differences and to learn the reasons for not keeping their appointment
Group 2 written educational information Patients receive notification of their colposcopy appointment and an educational letter about Pap smears cervical cancer risk and the purpose and procedure of colposcopy They complete the standardized Spanish survey questionnaire as in group 1
Group 3 phone call Patients receive notification of their colposcopy appointment and a personal telephone call educating them about Pap smears cervical cancer risk and the purpose and procedure of colposcopy They complete the standardized Spanish survey questionnaire as in group 1
All patients are asked to agree to submit residual Pap smear fluid to the Comprehensive Cancer Center of Wake Forest University tumor bank and be included in a tracking system to insure future follow-up communications
Primary
Determine the reasons for nonadherence to follow-up in Hispanic women with abnormal Pap smear findings
Assess the effect of written educational information and phone calls on follow-up rate in these patients
OUTLINE This is a pilot cross-sectional controlled multicenter study Patients are sequentially assigned to 1 of 3 intervention groups
Group 1 control Patients complete a standardized Spanish survey questionnaire assessing their demographic information knowledge attitudes behaviors experiences with cervical screening past medical history and prior treatment either in person for those who kept their colposcopy appointment or over the telephone for those who did not keep their colposcopy appointment Additional questions are added for patients who did not keep their colposcopy appointment to test for differences and to learn the reasons for not keeping their appointment
Group 2 written educational information Patients receive notification of their colposcopy appointment and an educational letter about Pap smears cervical cancer risk and the purpose and procedure of colposcopy They complete the standardized Spanish survey questionnaire as in group 1
Group 3 phone call Patients receive notification of their colposcopy appointment and a personal telephone call educating them about Pap smears cervical cancer risk and the purpose and procedure of colposcopy They complete the standardized Spanish survey questionnaire as in group 1
All patients are asked to agree to submit residual Pap smear fluid to the Comprehensive Cancer Center of Wake Forest University tumor bank and be included in a tracking system to insure future follow-up communications
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CCCWFU-BG04-578 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000547179 | REGISTRY | None | None |