NCT00508378

Brief Summary

Primary Objectives:

  • To compare preferences of women with ovarian cancer to preferences of their clinical caregivers.
  • To compare preferences of women with ovarian cancer to preferences of their familial caregivers.
  • To compare preferences of women with ovarian cancer to preferences of a women in the control group.
  • To prospectively collect quality of life data from women with ovarian cancer.
  • To prospectively collect symptom assessment data from women with ovarian cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
288

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2001

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

January 1, 2001

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 30, 2007

Completed
13.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

19.9 years

First QC Date

July 27, 2007

Last Update Submit

November 11, 2020

Conditions

Keywords

Ovarian CancerQuality of LifeChemotherapy Side-EffectsInterviewQuestionnaireCaregivers

Outcome Measures

Primary Outcomes (1)

  • Qualitative information on how ovarian cancer patients, their family members, and doctors and nurses feel about the side-effects of chemotherapy.

    8 Years

Secondary Outcomes (1)

  • Patient Response to Quality of Life Using Interview + Questionnaire

    30 minute interviews + 15 minutes for questionnaire

Study Arms (1)

Interview & Questionnaires

Behavioral: InterviewBehavioral: Questionnaire

Interventions

InterviewBEHAVIORAL

Interview regarding side-effects of chemotherapy, 30-45 minutes.

Also known as: Survey
Interview & Questionnaires
QuestionnaireBEHAVIORAL

Quality of life survey and symptom assessment questionnaire, 15 minutes.

Interview & Questionnaires

Eligibility Criteria

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

Ovarian cancer patients, their family members, and doctors and nurses from the UTMDACC Gynecologic Oncology Clinic.

You may qualify if:

  • Women with epithelial ovarian cancer presenting to the UTMDACC Gynecologic Oncology Clinic who are currently undergoing chemotherapy
  • Women with a history of epithelial ovarian cancer presenting to the UTMDACC Gynecologic Oncology Clinic who are seen in follow-up
  • Women who are at least 18 years of age
  • Women who speak English
  • Clinical caregivers of patients with ovarian cancer (UTMDACC gynecologic oncologists, UTMDACC gynecologic medical oncologists, UTMDACC registered nurses and licensed vocational nurses in the UTMDACC Gynecology Clinic, and UTMDACC gynecologic oncology fellows and residents)
  • Familial caregivers of patients with ovarian cancer (primary caregiver)

You may not qualify if:

  • Participants who are non-English speakers
  • Participants who are less than 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Interviews as TopicSurveys and Questionnaires

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 Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Diane C. Bodurka, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 27, 2007

First Posted

July 30, 2007

Study Start

January 1, 2001

Primary Completion

November 3, 2020

Study Completion

November 3, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11

Locations