Patient Satisfaction and Psychological Distress Related to Emerging Technologies for Cervical Cancer Screening and Diagnosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 1,938
- Locations
- 5
- Primary Endpoint
- Compare levels of patient anxiety, pain, and satisfaction associated with optical spectroscopy procedures and MDC with the levels associated with colposcopically-directed biopsy
Study Overview
Brief Summary
Primary Objectives:
- 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.
- 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.
- 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.
- To assess provider receptivity to optical spectroscopy. Aim 4 will be accomplished in Study D -- Survey of Health Care Providers.
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Studies A, A', and pilot tests
- •Eligible to participate in Project 2
- •Referred for an abnormal pap or has no history of abnormal pap
- •Consented to participate in the patient outcomes project.
- •Consented to participate in Project 3
- •Referred for an abnormal pap
- •Consented to participate in the patient outcome project.
- •Same as Study B.
- •Members of the American Society for Colposcopy and Cervical Pathology (ASCCP).
Exclusion Criteria
- •Studies A, A', and pilot tests through C:
- •Pregnancy
- •Unable to communicate in English, Spanish, or Chinese
Outcomes
Primary Outcomes
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
- Assess provider receptivity to optical spectroscopy(9 Years)
- Assess the psychosocial and behavioral impact of a false positive screening result.(9 Years)