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

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma; Bile Duct Cancer; Pancreatic Cancer; Colorectal Carcinoma; Liver Metastases; Primary Liver Cancer; Gallbladder Cancer
• Interventions: Other: Enhanced usual Care; Other: Collaborative Care

• Registration Number: NCT01640522
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2010-09-16
• Study First Submitted QC: 2012-07-12
• Study First Posted: 2012-07-13
• Primary Completion: 2013-12
• Study Completion: 2014-12
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 261

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Usual Care	Enhanced usual Care	Upon evaluation of symptoms the patient will be referred for further assessment or treatment if indicated
Collaborative Care Intervention	Collaborative Care	Care coordinator facilitates the assessment and treatment of cancer-related symptoms

Primary Outcome Measures

Name	Time	Method
Depression	Change from baseline at 6 and 12 months	Center for Epidemiological Studies-Depression scale

Secondary Outcome Measures

Name	Time	Method
Fatigue	Change from baseline at 6 and 12 months	Functional Assessment of Cancer Therapy-Fatigue

Trial Locations

Locations (1)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States