Clinical trial NCT00804258: Palliative Care During Intraperitoneal Chemotherapy in Patients With Ovarian Cancer
Official title: Integration of Palliative Care in Use of Intra-Peritoneal Chemotherapy for Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Keywords: 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
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-12-08
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients under the care of the Medical Oncology department at the City of Hope

Brief 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.

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 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

Primary outcomes:
measure: Symptoms/concerns before, during, and after intraperitoneal (IP) chemotherapy and their impact on quality of life (QOL)
timeFrame: 6 months from study entry
measure: Length of hospitalization, ICU admission rates, clinic visits, phone calls, urgent care visits, and other heath system encounters
timeFrame: 6 months from study entry
measure: Development of palliative care assessment measures and interventions that apply to IP chemotherapy
timeFrame: 6 months from study start
measure: Implementation of a palliative care intervention
timeFrame: 6 months from study entry
measure: Impact of implementing palliative care interventions on resource utilization, improved QOL and symptoms, and number of chemotherapy courses completed
timeFrame: 6 months from study entry
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
Study officials:
affiliation: City of Hope Comprehensive Cancer Center
name: Marcia Grant, RN, DNSc, FAAN
role: PRINCIPAL_INVESTIGATOR
References: