Palliative Care During Intraperitoneal Chemotherapy in Patients With Ovarian Cancer

November 4, 2015 updated by: City of Hope Medical Center

Integration of Palliative Care in Use of Intra-Peritoneal Chemotherapy for Ovarian Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Describe symptoms/concerns before, during, and after intraperitoneal (IP) chemotherapy and the impact of these symptoms/concerns on the quality of life (QOL) of patients with ovarian cancer undergoing IP chemotherapy. (Part I)
  • Analyze care received and resource utilization of these patients, including length of hospitalization, ICU admission rates, clinic visits, phone calls, urgent care visits, and other heath system encounters. (Part I)
  • Develop palliative care assessment measures and interventions that apply to IP chemotherapy. (Part II)
  • Implement a palliative care intervention in a pilot of 6 patients. (Part II)
  • Describe the impact of implementing palliative care interventions on resource utilization, improved QOL and symptoms, and number of chemotherapy courses completed. (Part II)

OUTLINE: This is a two-part study.

  • Part I (retrospective portion): Patients who have undergone intraperitoneal (IP) chemotherapy within the past 6-12 months undergo a retrospective interview and chart audit to identify their needs and experiences.
  • Part I (prospective portion): Patients are followed monthly for up to 6 months during IP chemotherapy to provide information about usual care and to identify needs and palliative care concerns. Patients also complete a quality-of-life (QOL) questionnaire (COH QOL Ovarian tool) and undergo a prospective interview.
  • Part II (intervention): Patients undergo comprehensive palliative care assessment, a patient teaching session prior to the initiation of IP chemotherapy, and a palliative care intervention during IP chemotherapy. Patients also complete a QOL questionnaire and undergo an interview. Patients are followed monthly for up to 6 months during IP chemotherapy.

Study Type

Observational

Enrollment (Actual)

17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010-3000
        • City of Hope Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Symptoms/concerns before, during, and after intraperitoneal (IP) chemotherapy and their impact on quality of life (QOL)
Time Frame: 6 months from study entry
6 months from study entry
Length of hospitalization, ICU admission rates, clinic visits, phone calls, urgent care visits, and other heath system encounters
Time Frame: 6 months from study entry
6 months from study entry
Development of palliative care assessment measures and interventions that apply to IP chemotherapy
Time Frame: 6 months from study start
6 months from study start
Implementation of a palliative care intervention
Time Frame: 6 months from study entry
6 months from study entry
Impact of implementing palliative care interventions on resource utilization, improved QOL and symptoms, and number of chemotherapy courses completed
Time Frame: 6 months from study entry
6 months from study entry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Marcia Grant, RN, DNSc, FAAN, City of Hope Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

December 5, 2008

First Submitted That Met QC Criteria

December 5, 2008

First Posted (Estimate)

December 8, 2008

Study Record Updates

Last Update Posted (Estimate)

November 6, 2015

Last Update Submitted That Met QC Criteria

November 4, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07007
  • P30CA033572 (U.S. NIH Grant/Contract)
  • CHNMC-07007 (Other Identifier: NCI PDQ)
  • CDR0000629073 (Registry Identifier: NCI PDQ)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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