Overview

This trial is active, not recruiting.

Conditions psychosocial, cervical cancer
Treatment questionnaire
Sponsor M.D. Anderson Cancer Center
Collaborator National Cancer Institute (NCI)
Start date July 1999
End date December 2017
Trial size 5885 participants
Trial identifier NCT00473798, BS98-269

Summary

Primary Objectives:

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective
Arm
Women who are eligible to participate in a study of the technical feasibility of optical spectroscopy will be invited to participate in this study.
questionnaire
Questionnaire
Women who are eligible to participate in a study of the technical feasibility of optical spectroscopy will be invited to participate in this study.
questionnaire
Questionnaire
Patients who have consented to participate in a randomized trial of optical spectroscopy.
questionnaire
Questionnaire
Women who are eligible to participate in a study of the technical feasibility of optical spectroscopy will be invited to participate in this study.
questionnaire
Questionnaire
Health care providers.
questionnaire
Questionnaire

Primary Outcomes

Measure
Compare levels of patient anxiety, pain, and satisfaction associated with optical spectroscopy procedures and MDC with the levels associated with colposcopically-directed biopsy
time frame: 9 Years
Evaluate differences in psychological distress, satisfaction, and adherence to treatment.
time frame: 9 Years

Secondary Outcomes

Measure
Assess the psychosocial and behavioral impact of a false positive screening result.
time frame: 9 Years
Assess provider receptivity to optical spectroscopy
time frame: 9 Years

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: 1. Studies A, A', and pilot tests - Eligible to participate in Project 2 - Over 18 - Referred for an abnormal pap or has no history of abnormal pap - Consented to participate in the patient outcomes project. 2. Study B - Consented to participate in Project 3 - Over 18 - Referred for an abnormal pap - Consented to participate in the patient outcome project. 3. Study C - Same as Study B. 4. Study D - Members of the American Society for Colposcopy and Cervical Pathology (ASCCP). Exclusion Criteria: 1. Studies A, A', and pilot tests through C: - Pregnancy - Unable to communicate in English, Spanish, or Chinese 2. Study D

Additional Information

Official title Patient Satisfaction and Psychological Distress Related to Emerging Technologies for Cervical Cancer Screening and Diagnosis
Principal investigator Karen Basen-Engquist, PhD
Description Randomized Clinical Trial: Participants in this study will be interviewed before and after they see the doctor for their first visit. They will be asked about their moods and the tests used to detect cervical cancer. They will also be asked about their symptom, how it is affecting their lives, and their satisfaction with their visit. Participants will be called approximately 2 weeks, 6 weeks, and 3 months after their appointments to answer questions about their health and quality of life, and the test and treatment they received. In addition, the participants will complete assessments at the 6, 12, 18, and 24 month clinic visits. If participants do not return for these follow-up appointments, the research staff will attempt to contact the participants to do brief interview by phone. Research staff will also review participant's medical records and gather information on diagnosis, treatment plans and adherence. This is an investigational study. A total of 360 patients will take part in this multicenter study. About 180 participants at M. D. Anderson will take part in this study. Studies A and A Prime: Participants in this study will be interviewed before they see the doctor. They will be asked about their moods and the tests used to detect cervical cancer. During the medical tests, participants will rate their pain and how tense they are. Someone will watch them to see whether they are upset or in pain. After they see the doctor, participants will be interviewed again about their mood and how much they liked or did not like the test. Some participants will be interviewed about their opinion of the test at the appointment when they receive their test results. Some participants will complete the Sequelae of LEEP/biopsy and medication use questionnaire. Some participants will be called 7 to 14 days and/or three months after their appointments. Some participants may answer some of the questions on a computer as well as in an interview. They will be asked to answer questions about their moods and about getting tests to detect cervical cancer. A sample of the participants will be selected to have their results visit tape recorded and to answer a few questions about what the doctor told them. Participants may be contacted to participate in discussion groups about tests for cervical dysplasia. Participation in the discussion groups is voluntary. Research staff will also review participant's medical records and gather information on diagnosis, treatment plans and adherence. This is an investigational study. A total of 3980 patients will take part in this multicenter study. About 2400 participants at M. D. Anderson will take part in this study.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.