Palliative Care During Intraperitoneal Chemotherapy in Patients With Ovarian Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00804258
First received: December 5, 2008
Last updated: September 7, 2012
Last verified: September 2012
  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
Drug: intraperitoneal chemotherapy
Other: educational intervention
Other: medical chart review
Other: questionnaire administration
Procedure: assessment of therapy complications
Procedure: end-of-life treatment/management
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Integration of Palliative Care in Use of Intra-Peritoneal Chemotherapy for Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Symptoms/concerns before, during, and after intraperitoneal (IP) chemotherapy and their impact on quality of life (QOL) [ Time Frame: 6 months from study entry ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Development of palliative care assessment measures and interventions that apply to IP chemotherapy [ Time Frame: 6 months from study start ] [ Designated as safety issue: No ]
  • Implementation of a palliative care intervention [ Time Frame: 6 months from study entry ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: August 2007
Primary Completion Date: January 2012 (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
Sampling Method:   Probability Sample
Study Population

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Marcia Grant, RN, DNSc, FAAN Beckman Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00804258     History of Changes
Other Study ID Numbers: 07007, P30CA033572, CHNMC-07007, CDR0000629073
Study First Received: December 5, 2008
Last Updated: September 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:
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

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on July 29, 2014