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

NCT01640522 | Completed

• 2 other identifiers: PRO07050143K07CA118576
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Depression

  Center for Epidemiological Studies-Depression scale

  Change from baseline at 6 and 12 months

Secondary Outcomes (1)

• Fatigue

  Change from baseline at 6 and 12 months

Study Arms (2)

Collaborative Care Intervention

EXPERIMENTAL

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

Other: Collaborative Care

Enhanced Usual Care

ACTIVE COMPARATOR

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

Other: Enhanced usual Care

Interventions

Collaborative Care OTHER

Collaborative care intervention to manage cancer-related symptoms

Collaborative Care Intervention

Enhanced usual Care OTHER

Enhanced Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• biopsy, radiological, and/or biological evidence of hepatobiliary carcinoma
• age 18 years or older

You may not qualify if:

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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Bile Duct Neoplasms; Pancreatic Neoplasms; Gallbladder Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Biliary Tract Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Gallbladder Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Jennifer L Steel, Ph.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only person evaluating outcomes
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Excellence in Behavioral Medicine

Model Details: Intervention versus standard of care

Study Record Dates

• First Submitted: September 16, 2010
• First Posted: July 13, 2012
• Study Start: January 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

US (1)