Palliative Care During Intraperitoneal Chemotherapy in Patients With Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00804258
• Other study ID #: 07007
• Secondary ID: P30CA033572CHNMC
• Status: Completed
• Phase: N/A
• First received: December 5, 2008
• Last updated: November 4, 2015
• Start date: August 2007
• Est. completion date: January 2012

Study information

• Verified date: November 2015
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• intraperitoneal chemotherapy

Other:
• educational intervention

• medical chart review

• questionnaire administration

Procedure:
• assessment of therapy complications

• end-of-life treatment/management

• psychosocial assessment and care

• quality-of-life assessment

Locations

Country	Name	City	State
United States	City of Hope Comprehensive Cancer Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms/concerns before, during, and after intraperitoneal (IP) chemotherapy and their impact on quality of life (QOL)		6 months from study entry	No
Primary	Length of hospitalization, ICU admission rates, clinic visits, phone calls, urgent care visits, and other heath system encounters		6 months from study entry	No
Primary	Development of palliative care assessment measures and interventions that apply to IP chemotherapy		6 months from study start	No
Primary	Implementation of a palliative care intervention		6 months from study entry	No
Primary	Impact of implementing palliative care interventions on resource utilization, improved QOL and symptoms, and number of chemotherapy courses completed		6 months from study entry	No