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Palliative Care During Intraperitoneal Chemotherapy in Patients With Ovarian Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: Beckman Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00804258
  Purpose

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.


Condition Intervention
Ovarian Cancer
Procedure: assessment of therapy complications
Procedure: educational intervention
Procedure: end-of-life treatment/management
Procedure: intraperitoneal chemotherapy
Procedure: medical chart review
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment
Procedure: questionnaire administration

MedlinePlus related topics: Cancer Ovarian Cancer Palliative Care
U.S. FDA Resources
Study Type: Observational
Official Title: Integration of Palliative Care in Use of Intra-Peritoneal Chemotherapy for Ovarian Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Symptoms/concerns before, during, and after intraperitoneal (IP) chemotherapy and their impact on quality of life (QOL) [ Designated as safety issue: No ]
  • Length of hospitalization, ICU admission rates, clinic visits, phone calls, urgent care visits, and other heath system encounters [ Designated as safety issue: No ]
  • Development of palliative care assessment measures and interventions that apply to IP chemotherapy [ Designated as safety issue: No ]
  • Implementation of a palliative care intervention [ Designated as safety issue: No ]
  • Impact of implementing palliative care interventions on resource utilization, improved QOL and symptoms, and number of chemotherapy courses completed [ Designated as safety issue: No ]

Estimated Enrollment: 26
Study Start Date: August 2007
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00804258

Locations
United States, California
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010-3000
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen     800-826-4673     becomingapatient@coh.org    
Sponsors and Collaborators
Beckman Research Institute
Investigators
Principal Investigator: Marcia Grant, RN, DNSc, FAAN Beckman Research Institute
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Responsible Party: City of Hope Comprehensive Cancer Center ( Marcia Grant )
Study ID Numbers: CDR0000629073, CHNMC-07007
Study First Received: December 5, 2008
Last Updated: December 6, 2008
ClinicalTrials.gov Identifier: NCT00804258  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer
recurrent ovarian germ cell tumor
stage I ovarian epithelial cancer
stage I ovarian germ cell tumor
stage II ovarian epithelial cancer
stage II ovarian germ cell tumor
stage III ovarian epithelial cancer
stage III ovarian germ cell tumor
stage IV ovarian epithelial cancer
stage IV ovarian germ cell tumor

Study placed in the following topic categories:
Genital Diseases, Female
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Endocrinopathy
Ovarian Diseases
Ovarian epithelial cancer
Recurrence
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009