NCT01037751

Brief Summary

Objectives: The objective of this study is to delineate and measure the symptom burden experienced by patients with ovarian cancer. The Primary Aim is to develop and validate an ovarian-cancer module of the M. D. Anderson Symptom Inventory (MDASI-Ovarian Cancer) to measure the severity of multiple symptoms and the impact of these symptoms on daily functioning in patients with ovarian cancers. The Secondary Aims are: To develop a detailed description of symptom severity and interference with daily activities experienced by patients with ovarian cancer; To assess the impact of symptom severity on standard functioning and quality of life (QOL) measures, including Eastern Cooperative Oncology Group Performance Status (ECOG PS), Functional Assessment of Cancer Therapy-Ovary (FACT-O), and a single-item QOL scale, in patients with ovarian cancer; To define the qualitative symptom burden of patients with ovarian cancer receiving various treatments.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2009

Longer than P75 for all trials

Geographic Reach
1 country

2 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

First Submitted

Initial submission to the registry

December 17, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 23, 2009

Completed
7 days until next milestone

Study Start

First participant enrolled

December 30, 2009

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2018

Completed
Last Updated

August 1, 2018

Status Verified

July 1, 2018

Enrollment Period

8.6 years

First QC Date

December 17, 2009

Last Update Submit

July 30, 2018

Conditions

Ovarian Cancer

Keywords

CancerSymptom burdenM. D. Anderson Symptom InventoryMDASI-Ovarian CancerSymptomsDaily functioningSymptom severityQuestionnaireInterview

Outcome Measures

Primary Outcomes (1)

  • Validate ovarian-cancer module of MDASI-Ovarian Cancer to measure severity of multiple symptoms + impact of these symptoms on daily functioning in patients with ovarian cancers.

    Baseline to 2 years (Patient participation done after completing Interview and Surveys during single clinic visit)

Secondary Outcomes (1)

  • Patient Rated Symptom Severity and Interference with Function (Survey Response)

    Baseline to 2 years

Study Arms (2)

Interview + Questionnaires

1-on-1 interview + Questionnaires, Part 1 of Study

Behavioral: InterviewBehavioral: Survey

Questionnaires

Questionnaires Only, Part 2 of Study

Behavioral: Survey

Interventions

InterviewBEHAVIORAL

1-on-1 interview with study doctor or staff member, during regularly scheduled, standard of care clinic visit taking 30 minutes.

Interview + Questionnaires
SurveyBEHAVIORAL

Complete 3 Questionnaires during clinic visit, about 10 minutes to complete all.

Also known as: Questionnaire
Interview + QuestionnairesQuestionnaires

Eligibility Criteria

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

UT MD Anderson Cancer Center ovarian cancer patients, females over the age of 18 years.

You may qualify if:

  • Female patients 18 years of age or older.
  • Able to speak and read English.
  • Having a diagnosis of high grade invasive epithelial ovarian cancer, peritoneal cancer or fallopian tube cancer confirmed by pathological analysis.
  • Being followed at M D Anderson Cancer Center and Lyndon B. Johnson General Hospital (LBJ Hospital).
  • Has consented to participate.
  • Has not received any current cancer treatment or prior chemotherapy in the last 30 days (phase 2 subset of 40 patients only)

You may not qualify if:

  • \) Having a medical condition or impaired performance status that would preclude participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lyndon B. Johnson General Hospital

Houston, Texas, 77026, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Ovarian NeoplasmsNeoplasms

Interventions

Interviews as TopicSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteOvarian 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, BS

    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

December 17, 2009

First Posted

December 23, 2009

Study Start

December 30, 2009

Primary Completion

July 18, 2018

Study Completion

July 18, 2018

Last Updated

August 1, 2018

Record last verified: 2018-07

Locations

US(2)