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


N/A
18 Years
N/A
Open (Enrolling)
Female
Psychosocial, Cervical Cancer

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Compare levels of patient anxiety, pain, and satisfaction associated with optical spectroscopy procedures and MDC with the levels associated with colposcopically-directed biopsy

Outcome Time Frame:

9 Years

Safety Issue:

No

Principal Investigator

Karen Basen-Engquist, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

BS98-269

NCT ID:

NCT00473798

Start Date:

July 1999

Completion Date:

Related Keywords:

  • Psychosocial
  • Cervical Cancer
  • Patient Satisfaction
  • Quality of Life
  • Psychological Distress
  • Cervical Cancer
  • Cervical Cancer Screening
  • Questionnaire
  • Uterine Cervical Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030
LBJ HospitalHouston, Texas  77030
Hermann Professional Building ClinicHouston, Texas  77030
Texas Medical Center ClinicHouston, Texas  77030