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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00473798 |
Primary Objectives:
Condition | Intervention |
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Psychosocial Cervical Cancer |
Behavioral: Questionnaire |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Patient Satisfaction and Psychological Distress Related to Emerging Technologies for Cervical Cancer Screening and Diagnosis |
Estimated Enrollment: | 5885 |
Study Start Date: | July 1999 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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A
Women who are eligible to participate in a study of the technical feasibility of optical spectroscopy will be invited to participate in this study.
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Behavioral: Questionnaire
Questionnaire
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A'
Women who are eligible to participate in a study of the technical feasibility of optical spectroscopy will be invited to participate in this study.
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Behavioral: Questionnaire
Questionnaire
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B
Patients who have consented to participate in a randomized trial of optical spectroscopy.
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Behavioral: Questionnaire
Questionnaire
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C
Women who are eligible to participate in a study of the technical feasibility of optical spectroscopy will be invited to participate in this study.
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Behavioral: Questionnaire
Questionnaire
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D
Health care providers.
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Behavioral: Questionnaire
Questionnaire
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Women who are eligible to participate in a study of the technical feasibility of optical spectroscopy. Total Accrual for Study A: 3510; Study A':
350; pilot tests for Study A': 120; Study B: 360; and Study C: 645. Health care providers will participate in Study D with a total accrual of 900.
Inclusion Criteria:
Studies A, A', and pilot tests
Study B
Study C
Study D
Exclusion Criteria:
Studies A, A', and pilot tests through C:
Study D
United States, Texas | |
U.T.M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
LBJ Hospital | |
Houston, Texas, United States, 77030 | |
Hermann Professional Building Clinic | |
Houston, Texas, United States, 77030 | |
Texas Medical Center Clinic | |
Houston, Texas, United States, 77030 | |
Canada, British Columbia | |
Vancouver General Hospital/British Columbia Cancer Agency | |
Vancouver, British Columbia, Canada, V5Z 1M9 |
Principal Investigator: | Karen Basen-Engquist, PhD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T. M.D. Anderson Cancer Center ( Karen Basen-Engquist,PhD/Professor ) |
Study ID Numbers: | BS98-269 |
Study First Received: | May 14, 2007 |
Last Updated: | October 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00473798 History of Changes |
Health Authority: | United States: Institutional Review Board |
Patient Satisfaction Quality of Life Psychological Distress |
Cervical Cancer Cervical Cancer Screening Questionnaire |
Quality of Life |