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CompletedNCT01640522CaSSYUpdated Dec 13, 2024

Comprehensive Electronic Cancer Support System for the Treatment of Cancer Related Symptoms

An interventional study of Collaborative Care and Enhanced usual Care in Hepatocellular Carcinoma, Primary Liver Cancer and Bile Duct Cancer, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-13.

Sponsored by University of Pittsburgh · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
261
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hepatocellular Carcinoma
  • Primary Liver Cancer
  • Bile Duct Cancer
  • Pancreatic Cancer
  • Gallbladder Cancer
  • Colorectal Carcinoma
  • Liver Metastases

Keywords

  • Hepatocellular carcinoma
  • Cholangio carcinoma
  • Primary Liver Cancer
  • Bile Duct CancerPancreatic Cancer
  • Gallbladder Cancer
  • Colorectal Carcinoma
  • Other Primary Cancers with Liver Metastases
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 261 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • current suicidal or homicidal ideation
  • current psychosis or thought disorder
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
261 participants (actual)

Study arms

  • Experimental
    Collaborative Care Intervention

    Care coordinator facilitates the assessment and treatment of cancer-related symptoms

    Other: Collaborative Care

  • Active comparator
    Enhanced Usual Care

    Upon evaluation of symptoms the patient will be referred for further assessment or treatment if indicated

    Other: Enhanced usual Care

Interventions

  • OtherCollaborative Care

    Collaborative care intervention to manage cancer-related symptoms

  • OtherEnhanced usual Care
06

What researchers measure

Primary outcomes

  1. Depression

    Center for Epidemiological Studies-Depression scale

    Time frame: Change from baseline at 6 and 12 months

Secondary outcomes

  1. Fatigue

    Functional Assessment of Cancer Therapy-Fatigue

    Time frame: Change from baseline at 6 and 12 months

07

Study locations

1 site
  • University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania 15213, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01640522
Lead sponsor
University of Pittsburgh
Collaborators
National Cancer Institute (NCI)
Responsible party
Jennifer Steel (Director, Center for Excellence in Behavioral Medicine, University of Pittsburgh) — Principal investigator
First posted
Jul 13, 2012
Start date
Jan 2008
Primary completion
Dec 2013
Completion
Dec 2014
Last update
Dec 13, 2024

Study contacts

Jennifer L Steel, Ph.D.
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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