Chemotherapy-Related Toxicities In Ovarian Cancer Patients

NCT ID: NCT00508378

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

288 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-01-31

Study Completion Date

2020-11-03

Brief Summary

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Primary Objectives:

1. 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.
2. To prospectively collect quality of life data from women with ovarian cancer.
3. To prospectively collect symptom assessment data from women with ovarian cancer.

Detailed Description

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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.

Conditions

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Ovarian Cancer

Keywords

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Ovarian Cancer Quality of Life Chemotherapy Side-Effects Interview Questionnaire Caregivers

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Interview & Questionnaires

Interview

Intervention Type BEHAVIORAL

Interview regarding side-effects of chemotherapy, 30-45 minutes.

Questionnaire

Intervention Type BEHAVIORAL

Quality of life survey and symptom assessment questionnaire, 15 minutes.

Interventions

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Interview

Interview regarding side-effects of chemotherapy, 30-45 minutes.

Intervention Type BEHAVIORAL

Questionnaire

Quality of life survey and symptom assessment questionnaire, 15 minutes.

Intervention Type BEHAVIORAL

Other Intervention Names

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Survey

Eligibility Criteria

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Inclusion Criteria

1. Women with epithelial ovarian cancer presenting to the UTMDACC Gynecologic Oncology Clinic who are currently undergoing chemotherapy
2. Women with a history of epithelial ovarian cancer presenting to the UTMDACC Gynecologic Oncology Clinic who are seen in follow-up
3. Women who are at least 18 years of age
4. Women who speak English
5. 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)
6. Familial caregivers of patients with ovarian cancer (primary caregiver)

Exclusion Criteria

1. Participants who are non-English speakers
2. Participants who are less than 18 years of age
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Diane C. Bodurka, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

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GYN00-409

Identifier Type: -

Identifier Source: org_study_id