Clinical trial NCT00508378: Chemotherapy-Related Toxicities In Ovarian Cancer Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Keywords: Ovarian Cancer
Quality of Life
Chemotherapy Side-Effects
Interview
Questionnaire
Caregivers
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2007-07-30
Enrollment: 288
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ovarian cancer patients, their family members, and doctors and nurses from the UTMDACC Gynecologic Oncology Clinic.

Brief 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.

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 criteria: 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

Primary outcomes:
measure: Qualitative information on how ovarian cancer patients, their family members, and doctors and nurses feel about the side-effects of chemotherapy.
timeFrame: 8 Years
Secondary outcomes:
measure: Patient Response to Quality of Life Using Interview + Questionnaire
timeFrame: 30 minute interviews + 15 minutes for questionnaire
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Diane C. Bodurka, MD
role: PRINCIPAL_INVESTIGATOR
References: