Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-30 @ 4:18 AM
Study NCT ID:
NCT00804258
Status:
COMPLETED
Last Update Posted:
2015-11-06
First Post:
2008-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Palliative Care During Intraperitoneal Chemotherapy in Patients With Ovarian Cancer
Sponsor:
City of Hope Medical Center
Organization:
Study Overview
Official Title:
Integration of Palliative Care in Use of Intra-Peritoneal Chemotherapy for Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA033572 | NIH | None | https://reporter.nih.gov/quic… | View |
| CHNMC-07007 | OTHER | NCI PDQ | View | |
| CDR0000629073 | REGISTRY | NCI PDQ | View |