NCT00596349

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2004

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 17, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

February 26, 2009

Status Verified

February 1, 2009

Enrollment Period

4.3 years

First QC Date

January 8, 2008

Last Update Submit

February 25, 2009

Conditions

Epithelial Ovarian CancerQuality of LifeSurvivorship

Keywords

epithelial Ovarian CancerQuality of LifeSurvivorship

Outcome Measures

Primary Outcomes (1)

  • 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.

    conclusion of study

Secondary Outcomes (1)

  • Identify potential determinants of global QOL in all three ovarian cancer survivor cohorts.

    conclusion of study

Study Arms (3)

A

epithelial ovarian cancer survivors (women disease-free at 5 to 10 years from diagnosis of ovarian cancer)

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).

Behavioral: questionnaires

C

women surviving with epithelial ovarian cancer (women alive with disease 5 to 10 years from original diagnosis of ovarian cancer)

Behavioral: questionnaires

Interventions

questionnairesBEHAVIORAL

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

A

Eligibility Criteria

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

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

You may qualify if:

  • 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

You may not qualify if:

  • Inability to read, communicate in English
  • ovarian cancer of low malignant potential (borderline tumors)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 8, 2008

First Posted

January 17, 2008

Study Start

November 1, 2004

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

February 26, 2009

Record last verified: 2009-02

Locations

US(1)