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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00804258
Enrollment
17
Registered
2008-12-08
Start date
2007-08-31
Completion date
2012-01-31
Last updated
2015-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

OTHEReducational intervention
OTHERmedical chart review
OTHERquestionnaire administration
PROCEDUREassessment of therapy complications
PROCEDUREpsychosocial assessment and care
PROCEDUREquality-of-life assessment

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
City of Hope Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Symptoms/concerns before, during, and after intraperitoneal (IP) chemotherapy and their impact on quality of life (QOL)6 months from study entry
Length of hospitalization, ICU admission rates, clinic visits, phone calls, urgent care visits, and other heath system encounters6 months from study entry
Development of palliative care assessment measures and interventions that apply to IP chemotherapy6 months from study start
Implementation of a palliative care intervention6 months from study entry
Impact of implementing palliative care interventions on resource utilization, improved QOL and symptoms, and number of chemotherapy courses completed6 months from study entry

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026