NCT00804258

Brief Summary

RATIONALE: Palliative care may help improve the quality of life of patients with ovarian cancer who are undergoing intraperitoneal chemotherapy. PURPOSE: This clinical trial is studying palliative care in patients with ovarian cancer who are undergoing intraperitoneal chemotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2007

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

August 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 8, 2008

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

November 6, 2015

Status Verified

November 1, 2015

Enrollment Period

4.4 years

First QC Date

December 5, 2008

Last Update Submit

November 4, 2015

Conditions

Ovarian Cancer

Keywords

recurrent ovarian epithelial cancerrecurrent ovarian germ cell tumorstage I ovarian epithelial cancerstage I ovarian germ cell tumorstage II ovarian epithelial cancerstage II ovarian germ cell tumorstage III ovarian epithelial cancerstage III ovarian germ cell tumorstage IV ovarian epithelial cancerstage IV ovarian germ cell tumor

Outcome Measures

Primary Outcomes (5)

  • Symptoms/concerns before, during, and after intraperitoneal (IP) chemotherapy and their impact on quality of life (QOL)

    6 months from study entry

  • Length of hospitalization, ICU admission rates, clinic visits, phone calls, urgent care visits, and other heath system encounters

    6 months from study entry

  • Development of palliative care assessment measures and interventions that apply to IP chemotherapy

    6 months from study start

  • Implementation of a palliative care intervention

    6 months from study entry

  • Impact of implementing palliative care interventions on resource utilization, improved QOL and symptoms, and number of chemotherapy courses completed

    6 months from study entry

Interventions

intraperitoneal chemotherapyDRUG
educational interventionOTHER
medical chart reviewOTHER
questionnaire administrationOTHER
assessment of therapy complicationsPROCEDURE
end-of-life treatment/managementPROCEDURE
psychosocial assessment and carePROCEDURE
quality-of-life assessmentPROCEDURE

Eligibility Criteria

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

Patients under the care of the Medical Oncology department at the City of Hope

DISEASE CHARACTERISTICS: * Diagnosis of ovarian cancer * Under the care of the Medical Oncology Department at the City of Hope National Medical Center * Undergoing intraperitoneal chemotherapy PATIENT CHARACTERISTICS: * Life expectancy \> 6 months * Speaks English or Spanish PRIOR CONCURRENT THERAPY: * 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 (1)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

Hyperthermic Intraperitoneal ChemotherapyEarly Intervention, EducationalTherapeuticsPsychiatric Rehabilitation

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

Intervention Hierarchy (Ancestors)

Chemotherapy, AdjuvantCombined Modality TherapyDrug TherapyHyperthermia, InducedChild Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesRehabilitation

Study Officials

  • Marcia Grant, RN, DNSc, FAAN

    City of Hope Comprehensive 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 5, 2008

First Posted

December 8, 2008

Study Start

August 1, 2007

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

November 6, 2015

Record last verified: 2015-11

Locations

US(1)