Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Women Surviving Ovarian Cancer

This study has been completed.
Sponsor:
Collaborator:
Queens Cancer Center of Queens Hospital
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00596349
First received: January 8, 2008
Last updated: February 25, 2009
Last verified: February 2009

January 8, 2008
February 25, 2009
November 2004
February 2009   (final data collection date for primary outcome measure)
QOL, phys funct status score on FACT & ,psychol status , cognitive functioning, Brief test of Attention, sexual funct & health behaviors among ovar ca survi & among women in 2nd or > remiss & among women surv with ovar ca 5 to 10 yrs from dx. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00596349 on ClinicalTrials.gov Archive Site
Identify potential determinants of global QOL in all three ovarian cancer survivor cohorts. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Women Surviving Ovarian Cancer
Quality of Life in Women Surviving Ovarian Cancer

The purpose of this study is to help us learn more about how women who have had or now have ovarian cancer are doing 5 years or more from their diagnosis. We want to learn about general quality of life, long-term side effects of treatment, sexual function, thinking, memory, and psychological effects (such as anxiety and depression). We will also look at how these women are being followed for ovarian cancer. We hope this study will help us better understand how women surviving ovarian cancer are doing.

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

Memorial Sloan-Kettering Cancer Center (MSKCC) clinic The Queens Cancer Center Hospital(QCC)clinic

  • Epithelial Ovarian Cancer
  • Quality of Life
  • Survivorship
  • Behavioral: questionnaires
    study participants complete one-time survey, questionnaires, and cognition testing, comprising the following: QOL-Cancer Survivor FACT-Ovarian SF-36 (general QOL scale) CES-D (depression scale) Impact of Events Scale (anxiety scale) FACT-GOG-NTX (neurotoxicity scale) Female Sexual Functioning Index (FSFI) Cognition Testing Perception of disease chronicity/acuity Concerns about Recurrence Report of surveillance type, frequency, utility Health behaviors Self-report of co-morbidities Self-report of potential unmet needs Background information form List of current medications Patient-defined QoL domains
  • Behavioral: questionnaires
    study participants complete one-time survey, questionnaires, and cognition testing, comprising the following: QOL- Cancer Survivor, FACT-Ovarian, SF-36, CES-D, IES, FACT-GOG-NTX, FSFI, Cognition Testing, Perception of disease chronicity/acuity, Report of surveillance type, frequency, utility, Health behaviors, Self-report of co-morbidities, Self-report of potential unmet needs, Background information form, List of current medications,Patient-defined QoL domains
  • A
    epithelial ovarian cancer survivors (women disease-free at 5 to 10 years from diagnosis of ovarian cancer)
    Intervention: Behavioral: questionnaires
  • B
    women in second- or greater remission (women who have had one or more relapses from ovarian cancer but are considered to be currently clinically disease-free 5 to 10 years from original diagnosis of ovarian cancer).
    Intervention: Behavioral: questionnaires
  • C
    women surviving with epithelial ovarian cancer (women alive with disease 5 to 10 years from original diagnosis of ovarian cancer)
    Intervention: Behavioral: questionnaires
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
February 2009
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women with invasive epithelial ovarian cancer who are disease-free and 5 to 10 years from diagnosis (for Cohort A) and have never experienced a recurrence of epithelial ovarian cancer
  • Women with epithelial ovarian cancer who have had one or more relapses, but are clinically currently disease-free, 5- to 10 years from diagnosis (for Cohort B)
  • Women with current evidence of epithelial ovarian cancer who are alive with disease 5 to 10 years from diagnosis (for Cohort C)
  • Fluency in English
  • Written informed consent

Exclusion Criteria:

  • Inability to read, communicate in English
  • ovarian cancer of low malignant potential (borderline tumors)
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00596349
04-131
Not Provided
Martee Hensley, MD, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Queens Cancer Center of Queens Hospital
Not Provided
Memorial Sloan-Kettering Cancer Center
February 2009

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