NCT00813254

Brief Summary

The goal of this research study is to learn about the quality of life and sexual functioning of women with platinum-resistant ovarian cancer as they receive other treatments for the disease. Researchers will study the costs for chemotherapy treatments, other medical expenses, and treatment-related expenses that are not medical. Researchers will also review any symptoms these patients may experience related to the cancer or treatment. In addition, researchers want to learn if and how these patients' caregivers feel the status of these patients' health may have affected the caregivers' productivity at work and at home.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

April 19, 2012

Status Verified

April 1, 2012

Enrollment Period

2.1 years

First QC Date

December 22, 2008

Last Update Submit

April 18, 2012

Conditions

Ovarian Cancer

Keywords

Platinum-Resistant Ovarian CancerPlatinum-based chemotherapyOvarian CancerOvaryEpithelial ovarian cancerQuality of LifeCost Utility AnalysisSexual functioningQuestionnaireCaregiver

Outcome Measures

Primary Outcomes (1)

  • Mean Score for the FACT-O instrument

    Participants will complete questionnaires 1 - 5 at baseline and Day 1 of each of their chemotherapy cycles.

    First 2 days of chemotherapy cycles

Study Arms (1)

Questionnaire

Longitudinal measure of QOL, sexual functioning and symptoms in women with recurrent, platinum-resistant ovarian cancer receiving multiple second-line treatment regimens

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

Questionnaires 1 - 5 will be completed on Day 1 of study as a Baseline.

Also known as: Survey
Questionnaire

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Female study participants that were diagnosed with Ovarian Cancer that are now "Platinum-Resistant."

You may qualify if:

  • Patients with recurrent, platinum-resistant epithelial ovarian cancer who are beginning any second-line treatment
  • Patients must be English-speaking
  • Patients must be able to read and write English
  • Patients receiving all chemotherapy at MD Anderson Cancer Center

You may not qualify if:

  • Patients with non-epithelial ovarian cancers including sex-cord stromal tumors, germ cell tumors, low-grade tumors, and metastatic disease to the ovary
  • Patients who are receiving protocol therapy
  • Patients who have had a prior diagnosis of invasive cancer at other sites (excluding basal cell carcinoma of the skin)
  • Patients who are receiving radiation therapy as a treatment modality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Michael M Frumovitz, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2008

First Posted

December 23, 2008

Study Start

December 1, 2008

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

April 19, 2012

Record last verified: 2012-04

Locations

US(1)