Patient Satisfaction & Quality Of Life in Patients With Cervical Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00473798
First received: May 14, 2007
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.

Condition Intervention
Psychosocial
Cervical Cancer
Behavioral: Questionnaire

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Patient Satisfaction and Psychological Distress Related to Emerging Technologies for Cervical Cancer Screening and Diagnosis

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Evaluate differences in psychological distress, satisfaction, and adherence to treatment. [ Time Frame: 9 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the psychosocial and behavioral impact of a false positive screening result. [ Time Frame: 9 Years ] [ Designated as safety issue: No ]
  • Assess provider receptivity to optical spectroscopy [ Time Frame: 9 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 5885
Study Start Date: July 1999
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A
Women who are eligible to participate in a study of the technical feasibility of optical spectroscopy will be invited to participate in this study.
Behavioral: Questionnaire
Questionnaire
A'
Women who are eligible to participate in a study of the technical feasibility of optical spectroscopy will be invited to participate in this study.
Behavioral: Questionnaire
Questionnaire
B
Patients who have consented to participate in a randomized trial of optical spectroscopy.
Behavioral: Questionnaire
Questionnaire
C
Women who are eligible to participate in a study of the technical feasibility of optical spectroscopy will be invited to participate in this study.
Behavioral: Questionnaire
Questionnaire
D
Health care providers.
Behavioral: Questionnaire
Questionnaire

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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Women who are eligible to participate in a study of the technical feasibility of optical spectroscopy. Total Accrual for Study A: 3510; Study A': 350; pilot tests for Study A': 120; Study B: 360; and Study C: 645. Health care providers will participate in Study D with a total accrual of 900.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00473798

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
LBJ Hospital
Houston, Texas, United States, 77030
Hermann Professional Building Clinic
Houston, Texas, United States, 77030
Texas Medical Center Clinic
Houston, Texas, United States, 77030
Canada, British Columbia
Vancouver General Hospital/British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Karen Basen-Engquist, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00473798     History of Changes
Other Study ID Numbers: BS98-269
Study First Received: May 14, 2007
Last Updated: March 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Patient Satisfaction
Quality of Life
Psychological Distress
Cervical Cancer
Cervical Cancer Screening
Questionnaire

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 23, 2014