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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:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00972634
First received: September 4, 2009
Last updated: November 28, 2011
Last verified: November 2011
History of Changes
  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:

MedlinePlus related topics: Cancer Depression
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • General user-friendliness of the tool [ Time Frame: Sept 2008-December 2009 ] [ Designated as safety issue: No ]
  • Performance of selected domains and items for classification and assessment of pain and cachexia [ Time Frame: Sept 2008-December 2009 ] [ Designated as safety issue: No ]
  • Validity of domains and items for depression [ Time Frame: Sept 2008-December 2009 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

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
Study First Received: September 4, 2009
Last Updated: November 28, 2011
Health Authority: Norway: Regional Ethics Commitee

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

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

ClinicalTrials.gov processed this record on May 21, 2013