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Palliative Care During Intraperitoneal Chemotherapy in Patients With Ovarian Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00804258
First received: December 5, 2008
Last updated: November 4, 2015
Last verified: November 2015

December 5, 2008
November 4, 2015
August 2007
January 2012   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
Complete list of historical versions of study NCT00804258 on ClinicalTrials.gov Archive Site
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Palliative Care During Intraperitoneal Chemotherapy in Patients With Ovarian Cancer
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.

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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample
Patients under the care of the Medical Oncology department at the City of Hope
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
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00804258
07007, P30CA033572, CHNMC-07007, CDR0000629073
Yes
Not Provided
Not Provided
City of Hope Medical Center
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Marcia Grant, RN, DNSc, FAAN City of Hope Comprehensive Cancer Center
City of Hope Medical Center
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP