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
  Purpose

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.


Condition Intervention
Epithelial Ovarian Cancer
Quality of Life
Survivorship
Behavioral: questionnaires

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life in Women Surviving Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Identify potential determinants of global QOL in all three ovarian cancer survivor cohorts. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: November 2004
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A
epithelial ovarian cancer survivors (women disease-free at 5 to 10 years from diagnosis of ovarian cancer)
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
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).
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
C
women surviving with epithelial ovarian cancer (women alive with disease 5 to 10 years from original diagnosis of ovarian cancer)
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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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)
  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: NCT00596349

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Queens Cancer Center of Queens Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Martee Hensley, MD, Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00596349     History of Changes
Other Study ID Numbers: 04-131
Study First Received: January 8, 2008
Last Updated: February 25, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
epithelial Ovarian Cancer
Quality of Life
Survivorship

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on July 23, 2014