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

NCT ID: NCT01640522

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

261 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2014-12-31

Brief Summary

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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

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The study is a collaborative care intervention designed to reduce pain, fatigue, and depressive symptoms and improve overall health related quality of life.

Conditions

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Hepatocellular Carcinoma Primary Liver Cancer Bile Duct Cancer Pancreatic Cancer Gallbladder Cancer Colorectal Carcinoma Liver Metastases

Keywords

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Hepatocellular carcinoma Cholangio carcinoma Primary Liver Cancer Bile Duct CancerPancreatic Cancer Gallbladder Cancer Colorectal Carcinoma Other Primary Cancers with Liver Metastases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention versus standard of care
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Only person evaluating outcomes

Study Groups

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Collaborative Care Intervention

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

Group Type EXPERIMENTAL

Collaborative Care

Intervention Type OTHER

Collaborative care intervention to manage cancer-related symptoms

Enhanced Usual Care

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

Group Type ACTIVE_COMPARATOR

Enhanced usual Care

Intervention Type OTHER

Interventions

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Collaborative Care

Collaborative care intervention to manage cancer-related symptoms

Intervention Type OTHER

Enhanced usual Care

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* current suicidal or homicidal ideation
* current psychosis or thought disorder
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Steel

Director, Center for Excellence in Behavioral Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer L Steel, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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K07CA118576

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO07050143

Identifier Type: -

Identifier Source: org_study_id