MDACC Study Summary BS98-269

Study Summary
No. BS98-269:.......Cervix......Karen Basen-Engquist......Behavioral Science

Study Summary Title



Study Summary Number:	BS98-269

Study Title:	Patient Satisfaction and Psychological Distress Related to Emerging Technologies for Cervical Cancer Screening and Diagnosis

Physician

New Patient Referral



Name:	Karen Basen-Engquist	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Behavioral Science	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-0919 Contact us about clinical trials

General Information



Disease Group:	Cervix	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	None

Treatment Agents:	None	Home Care:	Patients will be called at home (or other convenient location) for follow-up interviews conducted in Studies A', B, and C.

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this behavioral study is to try to find out whether participants prefer the new or old ways of detecting cervical cancer, and which ways they find more painful and upsetting.

Study Objectives / Outcomes

1. To compare levels of patient anxiety, pain, and satisfaction associated with optical spectroscopy procedures and MDC with the levels associated with colposcopically-directed biopsy in the cervical cancer diagnostic setting and with Papanicolaou smear in the screening setting. This aim will be addressed in Studies A and A' -- Procedure-Related Distress and Patient Satisfaction.

2. To evaluate differences in psychological distress, satisfaction, and adherence to treatment in the two arms of a randomized trial; one group will be diagnosed with usual care procedures (Papanicolaou smear and colposcopically-directed biopsy) plus optical spectroscopy and the second will receive usual care. Aim 2 will be accomplished in Study B -- Psychological Distress, Satisfaction, and Adherence Outcomes in a Randomized Trial of Optical Spectroscopy.

3. To assess the psychosocial and behavioral impact of a false positive screening result. This will be done in Study C -- Impact of False Positive Screening Test on Psychological Distress and Future Screening Intentions.

4. To assess provider receptivity to optical spectroscopy. Aim 4 will be accomplished in Study D -- Survey of Health Care Providers.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	11/18/1998

Study Type:

Recruitment Status:	Closed

Projected Accrual:	Study A: 3510; Study A': 350; pilot tests for Study A': 120; Study B: 360; Study C: 645; and Study D: 900.

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Studies A, A', and pilot tests - (1) eligible to participate in Project 2; (2) over 18; (3) referred for an abnormal pap or has no history of abnormal pap; (4) consented to participate in the patient outcomes project. Study B - (1) consented to participate in Project 3; (2) over 18; (3) referred for an abnormal pap; (4) consented to participate in the patient outcome project. Study C - inclusion criteria for abnormal pap smear group are the same as Study B. Study D - (1) members of the American Society for Colposcopy and Cervical Pathology (ASCCP).

Exclusion Criteria:

1) Studies A, A', and pilot tests through C - (1) pregnancy; (2) unable to communicate in English, Spanish, or Chinese; Study D - none

Links

Registration Number: NCT00473798
Study Information on Clinical Trials Registry (clinicaltrials.gov)