NCT01927393

Brief Summary

This randomized clinical trial studies palliative care in improving quality of life and symptoms in patients with stage III-IV pancreatic or ovarian cancer. Palliative therapy may help patients with advanced pancreatic or ovarian cancer live more comfortably.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2013

Completed
1.3 years until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Last Updated

December 23, 2014

Status Verified

December 1, 2014

Enrollment Period

2.8 years

First QC Date

August 20, 2013

Last Update Submit

December 18, 2014

Conditions

Recurrent Ovarian Epithelial CancerRecurrent Ovarian Germ Cell TumorRecurrent Pancreatic CancerStage III Pancreatic CancerStage IIIA Ovarian Epithelial CancerStage IIIA Ovarian Germ Cell TumorStage IIIB Ovarian Epithelial CancerStage IIIB Ovarian Germ Cell TumorStage IIIC Ovarian Epithelial CancerStage IIIC Ovarian Germ Cell TumorStage IV Ovarian Epithelial CancerStage IV Ovarian Germ Cell TumorStage IV Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

  • Overall QOL, assessed by the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) or the Functional Assessment of Cancer Therapy-Ovarian (FACT-O)

    The analysis will be a 2x2x3 repeated measures analysis of covariance (ANCOVA) statistical design.

    Up to 6 months

  • Symptom burden using the FACT-Trial Outcome Index (TOI)

    Compared between groups and by diagnoses using two-way contingency table analysis, two way analysis of variance (ANOVA) according to level of measurement.

    Up to 6 months

Secondary Outcomes (4)

  • Reduction in anxiety

    Up to 6 months

  • Reduction in depression

    Up to 6 months

  • Overall survival

    At 6 months

  • Health care resource use including presence of advanced care planning, chemotherapy in the last 14 days of life, and length of time between hospice referral and death

    Up to 6 months

Study Arms (2)

Arm I (PCPI)

EXPERIMENTAL

Patients undergo a comprehensive physical, psychological, social, and spiritual palliative care assessment. Patients also receive a workbook that covers physical and psychological well-being and social and spiritual well-being, delivered over 2 educational sessions.

Other: palliative careBehavioral: educational interventionProcedure: quality-of-life assessmentOther: questionnaire administration

Arm II (standard care plus attention control)

ACTIVE COMPARATOR

Patients receive standard care plus attention comprising two telephone contacts.

Procedure: quality-of-life assessmentOther: questionnaire administrationBehavioral: telephone-based intervention

Interventions

palliative careOTHER

Receive PCPI

Arm I (PCPI)
educational interventionBEHAVIORAL

Receive education sessions

Also known as: intervention, educational
Arm I (PCPI)
quality-of-life assessmentPROCEDURE

Ancillary studies

Also known as: quality of life assessment
Arm I (PCPI)Arm II (standard care plus attention control)
questionnaire administrationOTHER

Ancillary studies

Arm I (PCPI)Arm II (standard care plus attention control)
telephone-based interventionBEHAVIORAL

Receive telephone contacts

Arm II (standard care plus attention control)

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of pancreatic or ovarian cancer
  • Confirmed stage III or IV disease
  • Patients who are within one year from initial diagnosis
  • Able to read or understand English-this is included because most of the patient-reported outcome measures are not validated in linguistically diverse populations; the intent is to adapt and test the intervention in a future study with linguistically diverse populations
  • Ability to read and/or understand the study protocol requirements, and provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Carcinoma, Ovarian EpithelialPancreatic Neoplasms

Interventions

Palliative CareEarly Intervention, EducationalMethods

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersDigestive System NeoplasmsDigestive System DiseasesPancreatic Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesChild Health ServicesCommunity Health ServicesPreventive Health ServicesInvestigative Techniques

Study Officials

  • Virginia Sun

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2013

First Posted

August 22, 2013

Study Start

December 1, 2014

Primary Completion

October 1, 2017

Last Updated

December 23, 2014

Record last verified: 2014-12

Locations

US(1)