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Computerized Questionnaires in Assessing Symptoms, Pain, Depression, and Physical Function in Patients With Metastatic and/or Advanced Locoregional Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00972634
First Posted: September 7, 2009
Last Update Posted: January 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  Purpose

RATIONALE: A computer-based system for assessing symptoms may be effective for patients with metastatic or advanced cancer.

PURPOSE: This clinical trial is studying how well computerized questionnaires work in assessing symptoms, pain, depression, and physical function in patients with metastatic and/or advanced local/regional cancer.


Condition Intervention
Cachexia Depression Pain Unspecified Adult Solid Tumor, Protocol Specific Other: computer-assisted intervention Other: questionnaire administration Procedure: assessment of therapy complications Procedure: quality-of-life assessment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The European Palliative Care Research Collaborative - Computerised Symptom Assessment and Classification of Pain, Depression and Physical Function (Cachexia) (EPCRC - CSA)

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Feasibility of applying a computer based system for symptom assessment and classification in palliative cancer care [ Time Frame: Sept 2008-December 2009 ]
  • Differences across groups related to acceptance of computers (i.e., age, culture, stage of disease, cognitive and physical function, etc.) [ Time Frame: Sept 2008-December 2009 ]
  • General user-friendliness of the tool [ Time Frame: Sept 2008-December 2009 ]
  • Performance of selected domains and items for classification and assessment of pain and cachexia [ Time Frame: Sept 2008-December 2009 ]
  • Validity of domains and items for depression [ Time Frame: Sept 2008-December 2009 ]

Enrollment: 1051
Study Start Date: October 2008
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: computer-assisted intervention
    symptom assessment
    Other: questionnaire administration
    Symptom assessment
    Procedure: assessment of therapy complications
    Symptom assessment
    Procedure: quality-of-life assessment
    Symptom assessment
Detailed Description:

OBJECTIVES:

  • Determine the feasibility of applying a computer-based system for symptom assessment and classification in palliative cancer care in patients with metastatic and/or advanced cancer.
  • Examine hypothesized differences across groups related to acceptance of computers (i.e., age, culture, stage of disease, cognitive and physical function, etc.).
  • Examine the general user-friendliness of the tool.
  • Test and validate the performance of selected domains and items for classification and assessment of pain and cachexia.
  • Explore the validity of domains and items for depression.

OUTLINE: This is a multicenter study.

All patients undergo computer-based assessments of general symptoms by the Edmonton Symptom Assessment System (ESAS) and the European Organization for Research and Treatment of Cancer Core Quality of Life (EORTC QLQ C30) questionnaires and assessment of physical function, appetite/weight loss, and depression by the Brief Patient Health Questionnaire 9 (PRIME-MD PHQ9). Patients who score ≥ 1 (on a 0-10 numerical rating score) on the pain screening question with or without occurrence of breakthrough pain (BTP), undergo the Alberta BTP Assessment tool assessing precipitating factors for pain, time to pain relief after intake of medication, and satisfaction with medication. Patients complete questions regarding user-friendliness and feasibility of using the computer at the end of their session.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of incurable cancer, including patients receiving life-prolonging treatment
  • Metastatic and/or advanced locoregional disease

PATIENT CHARACTERISTICS:

  • Able to provide written informed consent
  • Fluent in the language used at the study site

PRIOR CONCURRENT THERAPY:

  • No prior inclusion in this study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00972634


Locations
Norway
Norwegian University of Science and Technology
Trondheim, Norway, N-7006
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Principal Investigator: Stein Kaasa, MD Norwegian University of Science and Technology
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00972634     History of Changes
Other Study ID Numbers: CDR0000648077
NUST-EPCRC-CSA
EU-20962
First Submitted: September 4, 2009
First Posted: September 7, 2009
Last Update Posted: January 18, 2017
Last Verified: January 2017

Keywords provided by Norwegian University of Science and Technology:
depression
cachexia
pain
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Depression
Depressive Disorder
Cachexia
Wasting Syndrome
Behavioral Symptoms
Mood Disorders
Mental Disorders
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders