Patient Satisfaction & Quality Of Life in Patients With Cervical Cancer

NCT00473798 | Completed DMC

• 1 other identifier: BS98-269
• Study Type: observational
• Target: 1,938
• Locations: 2 countries
• Sites: 5

Brief Summary

Primary Objectives:

1. 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. 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. 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. 4.To assess provider receptivity to optical spectroscopy. Aim 4 will be accomplished in Study D -- Survey of Health Care Providers.

Conditions

Psychosocial; Cervical Cancer

Keywords

Patient Satisfaction; Quality of Life; Psychological Distress; Cervical Cancer; Cervical Cancer Screening; Questionnaire

Outcome Measures

Primary Outcomes (2)

• 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

• Evaluate differences in psychological distress, satisfaction, and adherence to treatment.

  9 Years

Secondary Outcomes (2)

• Assess the psychosocial and behavioral impact of a false positive screening result.

  9 Years

• Assess provider receptivity to optical spectroscopy

  9 Years

Study Arms (5)

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

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

B

Patients who have consented to participate in a randomized trial of optical spectroscopy.

Behavioral: 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

D

Health care providers.

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

Questionnaire

A; A'; B; C; D

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (5)

Hermann Professional Building Clinic

Houston, Texas, 77030, United States

Location

LBJ Hospital

Houston, Texas, 77030, United States

Location

Texas Medical Center Clinic

Houston, Texas, 77030, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Vancouver General Hospital/British Columbia Cancer Agency

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Links

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

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Patient Satisfaction

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Karen Basen-Engquist, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2007
• First Posted: May 16, 2007
• Study Start: July 1, 1999
• Primary Completion: June 5, 2020
• Study Completion: June 5, 2020
• Last Updated: June 12, 2020

Record last verified: 2020-06

Locations

CA (1); US (4)