Patient Satisfaction & Quality Of Life in Patients With Cervical Cancer

Cervical Cancer Clinical Trial

Official title:

Patient Satisfaction and Psychological Distress Related to Emerging Technologies for Cervical Cancer Screening and Diagnosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00473798
• Other study ID #: BS98-269
• Status: Completed
• Start date: July 1, 1999
• Est. completion date: June 5, 2020

Study information

• Verified date: June 2020
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cervical Cancer
• Psychosocial
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• Questionnaire
Questionnaire

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

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

External Links

•   The University of Texas M.D.Anderson Cancer Center