Chemotherapy-Related Toxicities In Ovarian Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00508378
First received: July 27, 2007
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

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.

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:


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 2015 (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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 27, 2013
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 July 23, 2014