Clinical trial NCT00473798: Patient Satisfaction & Quality Of Life in Patients With Cervical Cancer
Official title: Patient Satisfaction and Psychological Distress Related to Emerging Technologies for Cervical Cancer Screening and Diagnosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychosocial
Cervical Cancer
Keywords: Patient Satisfaction
Quality of Life
Psychological Distress
Cervical Cancer
Cervical Cancer Screening
Questionnaire
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-05-16
Enrollment: 1938
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

Brief 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.

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 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

Primary outcomes:
measure: Compare levels of patient anxiety, pain, and satisfaction associated with optical spectroscopy procedures and MDC with the levels associated with colposcopically-directed biopsy
timeFrame: 9 Years
measure: Evaluate differences in psychological distress, satisfaction, and adherence to treatment.
timeFrame: 9 Years
Secondary outcomes:
measure: Assess the psychosocial and behavioral impact of a false positive screening result.
timeFrame: 9 Years
measure: Assess provider receptivity to optical spectroscopy
timeFrame: 9 Years
Other outcomes:
Locations:
city: Houston
country: United States
facility: Hermann Professional Building Clinic
state: Texas
city: Houston
country: United States
facility: LBJ Hospital
state: Texas
city: Houston
country: United States
facility: Texas Medical Center Clinic
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Vancouver
country: Canada
facility: Vancouver General Hospital/British Columbia Cancer Agency
state: British Columbia
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Karen Basen-Engquist, PhD
role: PRINCIPAL_INVESTIGATOR
References: