Palliative Care During Intraperitoneal Chemotherapy in Patients With Ovarian Cancer
This study has been completed.
Sponsor:
City of Hope Medical Center
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00804258
First received: December 5, 2008
Last updated: September 7, 2012
Last verified: September 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Ovarian Cancer |
Drug: intraperitoneal chemotherapy Other: educational intervention Other: medical chart review Other: questionnaire administration Procedure: assessment of therapy complications Procedure: end-of-life treatment/management Procedure: psychosocial assessment and care Procedure: quality-of-life assessment |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Integration of Palliative Care in Use of Intra-Peritoneal Chemotherapy for Ovarian Cancer |
Resource links provided by NLM:
Further study details as provided by City of Hope Medical Center:
Primary Outcome Measures:
- Symptoms/concerns before, during, and after intraperitoneal (IP) chemotherapy and their impact on quality of life (QOL) [ Time Frame: 6 months from study entry ] [ Designated as safety issue: No ]
- Length of hospitalization, ICU admission rates, clinic visits, phone calls, urgent care visits, and other heath system encounters [ Time Frame: 6 months from study entry ] [ Designated as safety issue: No ]
- Development of palliative care assessment measures and interventions that apply to IP chemotherapy [ Time Frame: 6 months from study start ] [ Designated as safety issue: No ]
- Implementation of a palliative care intervention [ Time Frame: 6 months from study entry ] [ Designated as safety issue: No ]
- Impact of implementing palliative care interventions on resource utilization, improved QOL and symptoms, and number of chemotherapy courses completed [ Time Frame: 6 months from study entry ] [ Designated as safety issue: No ]
| Enrollment: | 17 |
| Study Start Date: | August 2007 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients under the care of the Medical Oncology department at the City of Hope
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00804258
Locations
| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
Sponsors and Collaborators
City of Hope Medical Center
Investigators
| Principal Investigator: | Marcia Grant, RN, DNSc, FAAN | Beckman Research Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | City of Hope Medical Center |
| ClinicalTrials.gov Identifier: | NCT00804258 History of Changes |
| Other Study ID Numbers: | 07007, P30CA033572, CHNMC-07007, CDR0000629073 |
| Study First Received: | December 5, 2008 |
| Last Updated: | September 7, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by City of Hope Medical Center:
|
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 |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
ClinicalTrials.gov processed this record on May 16, 2013