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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 29, 2014
Last verified: September 2014

July 27, 2007
September 29, 2014
January 2001
January 2016   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00508378 on ClinicalTrials.gov Archive Site
Patient Response to Quality of Life Using Interview + Questionnaire [ Time Frame: 30 minute interviews + 15 minutes for questionnaire ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Chemotherapy-Related Toxicities In Ovarian Cancer Patients
Chemotherapy-Related Toxicities In Ovarian Cancer Patients: Preference Assessments of Patients, Family Members, Ancillary Staff and Gynecologic Oncologists, and Patients' Quality of Life

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

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

Ovarian Cancer
  • 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.
Interview & Questionnaires
Interventions:
  • Behavioral: Interview
  • Behavioral: Questionnaire
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
288
Not Provided
January 2016   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00508378
GYN00-409
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Diane C. Bodurka, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP