search
Back to results

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

Primary Purpose

Hepatocellular Carcinoma, Primary Liver Cancer, Bile Duct Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Collaborative Care
Enhanced usual Care
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hepatocellular Carcinoma focused on measuring Hepatocellular carcinoma, Cholangio carcinoma, Primary Liver Cancer, Bile Duct CancerPancreatic Cancer, Gallbladder Cancer, Colorectal Carcinoma, Other Primary Cancers with Liver Metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pittsburgh Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Collaborative Care Intervention

Enhanced Usual Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Depression
Center for Epidemiological Studies-Depression scale

Secondary Outcome Measures

Fatigue
Functional Assessment of Cancer Therapy-Fatigue

Full Information

First Posted
September 16, 2010
Last Updated
March 3, 2023
Sponsor
University of Pittsburgh
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT01640522
Brief Title
Comprehensive Electronic Cancer Support System for the Treatment of Cancer Related Symptoms
Acronym
CaSSY
Official Title
Phase III Randomized Controlled Trial of a Collaborative Care Intervention to Manage Cancer Related Symptoms in Patients Diagnosed With Hepatobiliary Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention versus standard of care
Masking
Outcomes Assessor
Masking Description
Only person evaluating outcomes
Allocation
Randomized
Enrollment
261 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Collaborative Care Intervention
Arm Type
Experimental
Arm Description
Care coordinator facilitates the assessment and treatment of cancer-related symptoms
Arm Title
Enhanced Usual Care
Arm Type
Active Comparator
Arm Description
Upon evaluation of symptoms the patient will be referred for further assessment or treatment if indicated
Intervention Type
Other
Intervention Name(s)
Collaborative Care
Intervention Description
Collaborative care intervention to manage cancer-related symptoms
Intervention Type
Other
Intervention Name(s)
Enhanced usual Care
Primary Outcome Measure Information:
Title
Depression
Description
Center for Epidemiological Studies-Depression scale
Time Frame
Change from baseline at 6 and 12 months
Secondary Outcome Measure Information:
Title
Fatigue
Description
Functional Assessment of Cancer Therapy-Fatigue
Time Frame
Change from baseline at 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer L Steel, Ph.D.
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs