MedDataX Logo

Women Surviving Ovarian Cancer

NCT ID: NCT00596349

Last Updated: 2009-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-11-30

Study Completion Date

2009-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Epithelial Ovarian Cancer Quality of Life Survivorship

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

epithelial Ovarian Cancer Quality of Life Survivorship

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

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

questionnaires

Intervention Type BEHAVIORAL

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).

questionnaires

Intervention Type BEHAVIORAL

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)

questionnaires

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Queens Cancer Center of Queens Hospital

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Memorial Sloan-Kettering Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://www.mskcc.org

Memorial Sloan-Kettering Cancer Center

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

04-131

Identifier Type: -

Identifier Source: org_study_id