Women Surviving Ovarian Cancer

Quality of Life Clinical Trial

Official title:

Quality of Life in Women Surviving Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00596349
• Other study ID #: 04-131
• Status: Completed
• Phase: N/A
• First received: January 8, 2008
• Last updated: February 25, 2009
• Start date: November 2004
• Est. completion date: February 2009

Study information

• Verified date: February 2009
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Epithelial Ovarian Cancer
• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms
• Quality of Life
• Survivorship

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Queens Cancer Center of Queens Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Identify potential determinants of global QOL in all three ovarian cancer survivor cohorts.		conclusion of study	No

External Links

•   Memorial Sloan-Kettering Cancer Center