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Clinical Trials/NCT01640522
NCT01640522
Completed
N/A

Phase III Randomized Controlled Trial of a Collaborative Care Intervention to Manage Cancer Related Symptoms in Patients Diagnosed With Hepatobiliary Carcinoma

University of Pittsburgh1 site in 1 country261 target enrollmentJanuary 2008
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ConditionsHepatocellular CarcinomaPrimary Liver CancerBile Duct CancerPancreatic CancerGallbladder CancerColorectal CarcinomaLiver Metastases

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hepatocellular Carcinoma
Sponsor
University of Pittsburgh
Enrollment
261
Locations
1
Primary Endpoint
Depression
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to test the efficacy of a collaborative care intervention to manage cancer-related symptoms and improve health related quality of life in patients diagnosed with hepatobiliary carcinoma.

Detailed Description

The study is a collaborative care intervention designed to reduce pain, fatigue, and depressive symptoms and improve overall health related quality of life.

Registry
clinicaltrials.gov
Start Date
January 2008
End Date
December 2014
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jennifer Steel

Director, Center for Excellence in Behavioral Medicine

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

  • •biopsy, radiological, and/or biological evidence of hepatobiliary carcinoma
  • •age 18 years or older
  • •fluency in English. Exclusion criteria included:

Exclusion Criteria

  • •current suicidal or homicidal ideation
  • •current psychosis or thought disorder

Outcomes

Primary Outcomes

Depression

Time Frame: Change from baseline at 6 and 12 months

Center for Epidemiological Studies-Depression scale

Secondary Outcomes

  • Fatigue(Change from baseline at 6 and 12 months)

Study Sites (1)

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