NCT00391664

Brief Summary

The purpose of this study is to evaluate the quality of life of long-term gynecologic cancer survivors.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2006

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

February 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2006

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

June 30, 2008

Status Verified

June 1, 2008

First QC Date

October 23, 2006

Last Update Submit

June 26, 2008

Conditions

Endometrial NeoplasmsOvarian NeoplasmsUterine Cervical NeoplasmsVulvar NeoplasmsVaginal NeoplasmsGenital Neoplasms, Female

Keywords

Endometrial cancerOvarian CancerCervical CancerGenital CancerVulvar CancerVaginal CancerOther Gynecological Cancers

Interventions

PsychosocialBEHAVIORAL

Eligibility Criteria

Age20 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female participants diagnosed with gynecologic cancer
  • Participants between the ages of 20 and 75 years old, inclusive
  • Participants previously treated for all stages (I-IV) of the following cancers: cervix; endometrium; ovary; vulva; vagina; and other genital cancers
  • Participants receiving treatment for their primary cancer in the past 2-10 years

You may not qualify if:

  • Male participants
  • Participants with major psychoses (e.g. organic brain syndrome; schizophrenia; bipolar disorder; or mental retardation).
  • Participants with significant hearing deficit
  • Participants with prior non-gynecologic cancer diagnosis
  • Participants who refused all forms of cancer treatment, whether standard of care or experimental.
  • Participants with deficient ability to read/speak English
  • Participants residing \>90 miles from the research site
  • Participants diagnosed with dementia
  • Participants diagnosed with pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Endometrial NeoplasmsOvarian NeoplasmsUterine Cervical NeoplasmsVulvar NeoplasmsVaginal NeoplasmsGenital Neoplasms, Female

Condition Hierarchy (Ancestors)

Uterine NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal DisordersUterine Cervical DiseasesVulvar DiseasesVaginal Diseases

Study Officials

  • Barbara L Andersen, PhD

    Ohio State University

    STUDY DIRECTOR

  • LTC G. Larry Maxwell, MD

    Walter Reed Army Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Petersen

CONTACT

(614) 292-6874peterson.266@osu.edu

Carolyn Hagopian

CONTACT

(614) 292-3541hagopian.5@osu.edu

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
FED

Study Record Dates

First Submitted

October 23, 2006

First Posted

October 24, 2006

Study Start

February 1, 2006

Study Completion

February 1, 2011

Last Updated

June 30, 2008

Record last verified: 2008-06

Locations

US(2)