- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00804258
Palliative Care During Intraperitoneal Chemotherapy in Patients With Ovarian Cancer
Integration of Palliative Care in Use of Intra-Peritoneal Chemotherapy for Ovarian Cancer
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
- Andet: medicinsk diagram gennemgang
- Andet: spørgeskemaadministration
- Procedure: psykosocial vurdering og omsorg
- Procedure: livskvalitetsvurdering
- Andet: pædagogisk intervention
- Procedure: vurdering af terapikomplikationer
- Procedure: end-of-life behandling/håndtering
- Medicin: intraperitoneal chemotherapy
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
California
-
Duarte, California, Forenede Stater, 91010-3000
- City of Hope Comprehensive Cancer Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Symptoms/concerns before, during, and after intraperitoneal (IP) chemotherapy and their impact on quality of life (QOL)
Tidsramme: 6 months from study entry
|
6 months from study entry
|
|
Length of hospitalization, ICU admission rates, clinic visits, phone calls, urgent care visits, and other heath system encounters
Tidsramme: 6 months from study entry
|
6 months from study entry
|
|
Development of palliative care assessment measures and interventions that apply to IP chemotherapy
Tidsramme: 6 months from study start
|
6 months from study start
|
|
Implementation of a palliative care intervention
Tidsramme: 6 months from study entry
|
6 months from study entry
|
|
Impact of implementing palliative care interventions on resource utilization, improved QOL and symptoms, and number of chemotherapy courses completed
Tidsramme: 6 months from study entry
|
6 months from study entry
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Marcia Grant, RN, DNSc, FAAN, City of Hope Comprehensive Cancer Center
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- stadium III ovarieepitelkræft
- stadium IV ovarieepitelkræft
- tilbagevendende ovarieepitelkræft
- stadium I ovarieepitelkræft
- stadium II ovarieepitelkræft
- tilbagevendende ovarie-kimcelletumor
- stadium I ovarie-kimcelletumor
- stadium II ovarie-kimcelletumor
- stadium III ovarie-kimcelletumor
- stadium IV ovarie-kimcelletumor
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Karcinom
- Neoplasmer, kirtel og epitel
- Genitale neoplasmer, kvindelige
- Sygdomme i det endokrine system
- Ovariesygdomme
- Adnexale sygdomme
- Gonadale lidelser
- Neoplasmer i endokrine kirtler
- Ovariale neoplasmer
- Karcinom, ovarieepitel
Andre undersøgelses-id-numre
- 07007
- P30CA033572 (U.S. NIH-bevilling/kontrakt)
- CHNMC-07007 (Anden identifikator: NCI PDQ)
- CDR0000629073 (Registry Identifier: NCI PDQ)
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