NCT00003772

Brief Summary

RATIONALE: Quality-of-life assessment in patients undergoing cancer treatment may help determine the intermediate- and long-term effects of treatment. PURPOSE: This clinical trial studies the quality of life in patients with ovarian cancer.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
372

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1999

Longer than P75 for all trials

Geographic Reach
4 countries

4 active sites

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

January 1, 1999

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2001

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2003

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

March 15, 2004

Completed
Last Updated

August 27, 2012

Status Verified

August 1, 2012

Enrollment Period

2.6 years

First QC Date

November 1, 1999

Last Update Submit

August 24, 2012

Conditions

Ovarian Cancer

Keywords

stage I ovarian epithelial cancerstage II ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerrecurrent ovarian epithelial cancer

Interventions

quality-of-life assessmentPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ovarian cancer

DISEASE CHARACTERISTICS: Diagnosis of ovarian epithelial carcinoma No prior participation in this study as a member of a different group Group 1: Prior surgery required Scheduled for first line chemotherapy No chemotherapy prior to surgery Group 2: Prior surgery required Completion of 6 courses of first line platinum-based chemotherapy required within 8 weeks prior to study Group 3: Must have achieved complete response to first line therapy At least 3 months since any therapy for cancer Prior surgery required Prior chemotherapy allowed Prior radiotherapy allowed Group 4: Must have recurrent disease Scheduled for chemotherapy Prior surgery required Prior chemotherapy allowed Prior radiotherapy allowed PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No concurrent malignancies except basal cell carcinoma of the skin No mental disease or language barrier that would prevent compliance No concurrent participation in any other quality of life study that might interfere with this study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Landeskrankenhaus/Universitatskliniken Graz

Graz, A-8036, Austria

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Hospital De Navarra

Pamplona, 31080, Spain

Location

Western General Hospital

Edinburgh, Scotland, EH4 9NQ, United Kingdom

Location

Related Publications (2)

  • Chie WC, Tsai CJ, Chiang C, Lee YC. Quality of life of patients with oesophageal cancer in Taiwan: validation and application of the Taiwan Chinese (Mandarin) version of the EORTC QLQ-OES18: a brief communication. Qual Life Res. 2010 Oct;19(8):1127-31. doi: 10.1007/s11136-010-9675-8. Epub 2010 May 22.

    PMID: 20495876RESULT

  • Cull A, Howat S, Greimel E, Waldenstrom AC, Arraras J, Kudelka A, Chauvenet L, Gould A; EORTC Quality of Life Group [European Organization for Research and Treatment of Cancer]; Scottish Gynaecological Cancer Trials Group. Development of a European Organization for Research and Treatment of Cancer questionnaire module to assess the quality of life of ovarian cancer patients in clinical trials: a progress report. Eur J Cancer. 2001 Jan;37(1):47-53. doi: 10.1016/s0959-8049(00)00369-5.

    PMID: 11165129RESULT

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Ann Cull, PhD

    Edinburgh Cancer Centre at Western General Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

March 15, 2004

Study Start

January 1, 1999

Primary Completion

August 1, 2001

Study Completion

February 1, 2003

Last Updated

August 27, 2012

Record last verified: 2012-08

Locations

GB(1)ES(1)AU(1)FR(1)