Comprehensive Electronic Cancer Support System for the Treatment of Cancer Related Symptoms (CaSSY)

December 11, 2024 updated by: Jennifer Steel, University of Pittsburgh

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

261

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Collaborative Care Intervention
Care coordinator facilitates the assessment and treatment of cancer-related symptoms
Other: Collaborative Care
Collaborative care intervention to manage cancer-related symptoms
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: Change from baseline at 6 and 12 months
Center for Epidemiological Studies-Depression scale
Change from baseline at 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue
Time Frame: Change from baseline at 6 and 12 months
Functional Assessment of Cancer Therapy-Fatigue
Change from baseline at 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Jennifer L Steel, Ph.D., University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

September 16, 2010

First Submitted That Met QC Criteria

July 12, 2012

First Posted (Estimated)

July 13, 2012

Study Record Updates

Last Update Posted (Actual)

December 13, 2024

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO07050143
  • K07CA118576 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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