Cervical Cancer Clinical Trial
Official title:
Patient Satisfaction and Psychological Distress Related to Emerging Technologies for Cervical Cancer Screening and Diagnosis
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.
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.
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