Palliative Care During Intraperitoneal Chemotherapy in Patients With Ovarian Cancer

NCT ID: NCT00804258

Last Updated: 2015-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2012-01-31

Brief Summary

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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

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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.

Conditions

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Ovarian Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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intraperitoneal chemotherapy

Intervention Type DRUG

educational intervention

Intervention Type OTHER

medical chart review

Intervention Type OTHER

questionnaire administration

Intervention Type OTHER

assessment of therapy complications

Intervention Type PROCEDURE

end-of-life treatment/management

Intervention Type PROCEDURE

psychosocial assessment and care

Intervention Type PROCEDURE

quality-of-life assessment

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marcia Grant, RN, DNSc, FAAN

Role: PRINCIPAL_INVESTIGATOR

City of Hope Comprehensive Cancer Center

Locations

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City of Hope Comprehensive Cancer Center

Duarte, California, United States

Site Status

Countries

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United States

Other Identifiers

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P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CHNMC-07007

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000629073

Identifier Type: REGISTRY

Identifier Source: secondary_id

07007

Identifier Type: -

Identifier Source: org_study_id

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