Chemotherapy-Related Toxicities In Ovarian Cancer Patients - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00508378

Purpose

Primary Objectives:

To assess the preferences of women with ovarian cancer, their clinical caregivers, familial caregivers, and a control group for toxicities associated with chemotherapy.
- To compare preferences of women with ovarian cancer to preferences of their clinical caregivers.
- To compare preferences of women with ovarian cancer to preferences of their familial caregivers.
- To compare preferences of women with ovarian cancer to preferences of a women in the control group.
To prospectively collect quality of life data from women with ovarian cancer.
To prospectively collect symptom assessment data from women with ovarian cancer.

Condition	Intervention
Ovarian Cancer	Behavioral: Interview Behavioral: Questionnaire

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Chemotherapy-Related Toxicities In Ovarian Cancer Patients: Preference Assessments of Patients, Family Members, Ancillary Staff and Gynecologic Oncologists, and Patients' Quality of Life

Resource links provided by NLM:

MedlinePlus related topics: Cancer Caregivers Ovarian Cancer

U.S. FDA Resources

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

Primary Outcome Measures:

Qualitative information on how ovarian cancer patients, their family members, and doctors and nurses feel about the side-effects of chemotherapy. [ Time Frame: 8 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient Response to Quality of Life Using Interview + Questionnaire [ Time Frame: 30 minute interviews + 15 minutes for questionnaire ] [ Designated as safety issue: No ]

Estimated Enrollment:	288
Study Start Date:	January 2001
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Interview & Questionnaires	Behavioral: Interview Interview regarding side-effects of chemotherapy, 30-45 minutes. Other Name: Survey Behavioral: Questionnaire Quality of life survey and symptom assessment questionnaire, 15 minutes.

Detailed Description:

Patients in this study will be recruited from the Gynecologic Oncology Clinic waiting area. All participants (patients, family and clinical caregivers, control group women with no cancer) in this study will take part in an interview to see how they feel about the different side-effects of chemotherapy. The interview will involve reading short descriptions of the side-effects and then answering some questions that ask for an opinion. The actual interview will take about 30-45 minutes to complete. The interviews will either take place in private conference rooms in the clinic or in private rooms at the Ambulatory Treatment Center (ATC).

Patients will also be given quality of life and symptom assessment questionnaires. The questionnaires are simple to read and quick to answer. The questionnaire takes about 15 minutes to complete.

The participant's involvement in this study is limited to the questionnaire/interview. Once that is done, the participant is finished with the study.

This is an investigational study. A total of 288 people will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility

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

Study Population

Ovarian cancer patients, their family members, and doctors and nurses from the UTMDACC Gynecologic Oncology Clinic.

Criteria

Inclusion Criteria:

Women with epithelial ovarian cancer presenting to the UTMDACC Gynecologic Oncology Clinic who are currently undergoing chemotherapy
Women with a history of epithelial ovarian cancer presenting to the UTMDACC Gynecologic Oncology Clinic who are seen in follow-up
Women who are at least 18 years of age
Women who speak English
Clinical caregivers of patients with ovarian cancer (UTMDACC gynecologic oncologists, UTMDACC gynecologic medical oncologists, UTMDACC registered nurses and licensed vocational nurses in the UTMDACC Gynecology Clinic, and UTMDACC gynecologic oncology fellows and residents)
Familial caregivers of patients with ovarian cancer (primary caregiver)

Exclusion Criteria:

Participants who are non-English speakers
Participants who are less than 18 years of age

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00508378

Locations

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Diane C. Bodurka, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00508378 History of Changes
Other Study ID Numbers:	GYN00-409
Study First Received:	July 27, 2007
Last Updated:	September 22, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Ovarian Cancer
Quality of Life
Chemotherapy Side-Effects

Interview
Questionnaire
Caregivers

Additional relevant MeSH terms:

Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases

Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on February 09, 2012