Patient Satisfaction & Quality Of Life in Patients With Cervical Cancer

Completed

Conditions studied: Psychosocial, Cervical Cancer

In brief

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.

Key facts

Study ID

NCT00473798

Run by

M.D. Anderson Cancer Center

People needed

1938

Starts

1999-07-01

Expected to finish

2020-06-05

Last updated by the study team

2020-06-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.
• Study B
• Consented to participate in Project 3
• Over 18
• Referred for an abnormal pap
• Consented to participate in the patient outcome project.
• Study C
• Same as Study B.
• Study D
• Members of the American Society for Colposcopy and Cervical Pathology (ASCCP).

You may not qualify if…

• Studies A, A', and pilot tests through C:
• Pregnancy
• Unable to communicate in English, Spanish, or Chinese
• Study D
• None

Where it is running

• 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, United States
• Vancouver General Hospital/British Columbia Cancer Agency — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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