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

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT01640522
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 261
• Location: 1
• Arms: 2
• Duration (Months): 83
• Patients Per Site Per Month: 3.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma; Primary Liver Cancer; Bile Duct Cancer; Pancreatic Cancer; Gallbladder Cancer; Colorectal Carcinoma; Liver Metastases	Other: Collaborative Care; Other: Enhanced usual Care	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 261 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Phase III Randomized Controlled Trial of a Collaborative Care Intervention to Manage Cancer Related Symptoms in Patients Diagnosed With Hepatobiliary Carcinoma
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Depression [Change from baseline at 6 and 12 months]

   Center for Epidemiological Studies-Depression scale

Secondary Outcome Measures

1. Fatigue [Change from baseline at 6 and 12 months]

   Functional Assessment of Cancer Therapy-Fatigue

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

• current suicidal or homicidal ideation

• current psychosis or thought disorder

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• University of Pittsburgh
• National Cancer Institute (NCI)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jennifer Steel, Director, Center for Excellence in Behavioral Medicine, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT01640522
• Other Study ID Numbers: PRO07050143; K07CA118576
• First Posted: Jul 13, 2012
• Last Update Posted: Dec 24, 2015
• Last Verified: Jul 1, 2012

• Keywords provided by Jennifer Steel, Director, Center for Excellence in Behavioral Medicine, University of Pittsburgh: Hepatocellular carcinoma; Cholangio carcinoma; Primary Liver Cancer; Bile Duct CancerPancreatic Cancer; Gallbladder Cancer; Colorectal Carcinoma; Other Primary Cancers with Liver Metastases
• Additional relevant MeSH terms: Carcinoma; Neoplasm Metastasis; Carcinoma, Hepatocellular; Liver Neoplasms; Colorectal Neoplasms; Gallbladder Neoplasms; Bile Duct Neoplasms

Study Results

No Results Posted as of Dec 24, 2015