Cervical Cancer Clinical Trial
Official title:
Patient Satisfaction and Psychological Distress Related to Emerging Technologies for Cervical Cancer Screening and Diagnosis
NCT number | NCT00473798 |
Other study ID # | BS98-269 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 1, 1999 |
Est. completion date | June 5, 2020 |
Verified date | June 2020 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1938 |
Est. completion date | June 5, 2020 |
Est. primary completion date | June 5, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 - None |
Country | Name | City | State |
---|---|---|---|
Canada | Vancouver General Hospital/British Columbia Cancer Agency | Vancouver | British Columbia |
United States | Hermann Professional Building Clinic | Houston | Texas |
United States | LBJ Hospital | Houston | Texas |
United States | Texas Medical Center Clinic | Houston | Texas |
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compare levels of patient anxiety, pain, and satisfaction associated with optical spectroscopy procedures and MDC with the levels associated with colposcopically-directed biopsy | 9 Years | ||
Primary | Evaluate differences in psychological distress, satisfaction, and adherence to treatment. | 9 Years | ||
Secondary | Assess the psychosocial and behavioral impact of a false positive screening result. | 9 Years | ||
Secondary | Assess provider receptivity to optical spectroscopy | 9 Years |
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