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Palliative Care During Intraperitoneal Chemotherapy in Patients With Ovarian Cancer

4. november 2015 oppdatert av: City of Hope Medical Center

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.

Studieoversikt

Status

Fullført

Forhold

Eggstokkreft

Intervensjon / Behandling

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Forente stater
- California
  - Duarte, California, Forente stater, 91010-3000
    - City of Hope Comprehensive Cancer Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

Patients under the care of the Medical Oncology department at the City of Hope

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

City of Hope Medical Center

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

Hovedetterforsker: Marcia Grant, RN, DNSc, FAAN, City of Hope Comprehensive Cancer Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 2007

Primær fullføring (Faktiske)

1. januar 2012

Studiet fullført (Faktiske)

1. januar 2012

Datoer for studieregistrering

Først innsendt

5. desember 2008

Først innsendt som oppfylte QC-kriteriene