Chemotherapy-Related Toxicities In Ovarian Cancer Patients

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00508378
• Other study ID #: GYN00-409
• Status: Completed
• Start date: January 2001
• Est. completion date: November 3, 2020

Study information

• Verified date: November 2020
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: November 3, 2020
• Est. primary completion date: November 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Behavioral:
• Interview
Interview regarding side-effects of chemotherapy, 30-45 minutes.
• Questionnaire
Quality of life survey and symptom assessment questionnaire, 15 minutes.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative information on how ovarian cancer patients, their family members, and doctors and nurses feel about the side-effects of chemotherapy.		8 Years
Secondary	Patient Response to Quality of Life Using Interview + Questionnaire		30 minute interviews + 15 minutes for questionnaire

External Links

•   University of Texas MD Anderson Cancer Center Website