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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma, Primary Liver Cancer, Bile Duct Cancer, Pancreatic Cancer, Gallbladder Cancer, Colorectal Carcinoma, Liver Metastases

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Depression

Outcome Description:

Center for Epidemiological Studies-Depression scale

Outcome Time Frame:

Change from baseline at 6 and 12 months

Safety Issue:

No

Principal Investigator

Jennifer L Steel, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Institutional Review Board

Study ID:

PRO07050143

NCT ID:

NCT01640522

Start Date:

January 2008

Completion Date:

June 2013

Related Keywords:

  • Hepatocellular Carcinoma
  • Primary Liver Cancer
  • Bile Duct Cancer
  • Pancreatic Cancer
  • Gallbladder Cancer
  • Colorectal Carcinoma
  • Liver Metastases
  • Hepatocellular carcinoma
  • Cholangio carcinoma
  • Primary Liver Cancer
  • Bile Duct CancerPancreatic Cancer
  • Gallbladder Cancer
  • Colorectal Carcinoma
  • Other Primary Cancers with Liver Metastases
  • Carcinoma
  • Colorectal Neoplasms
  • Liver Neoplasms
  • Neoplasm Metastasis
  • Pancreatic Neoplasms
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms
  • Carcinoma, Hepatocellular

Name

Location
University of Pittsburgh Medical Center Pittsburgh, Pennsylvania  15213