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

September 4, 2009
November 28, 2011
October 2008
November 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • Feasibility of applying a computer based system for symptom assessment and classification in palliative cancer care [ Designated as safety issue: No ]
  • Differences across groups related to acceptance of computers (i.e., age, culture, stage of disease, cognitive, and physical function) [ Designated as safety issue: No ]
  • General user-friendliness of the tool [ Designated as safety issue: No ]
  • Performance of selected domains and items for classification and assessment of pain and cachexia [ Designated as safety issue: No ]
  • Validity of domains and items for depression [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00972634 on ClinicalTrials.gov Archive Site
Not Provided
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Computerized Questionnaires in Assessing Symptoms, Pain, Depression, and Physical Function in Patients With Metastatic and/or Advanced Locoregional Cancer
The European Palliative Care Research Collaborative - Computerised Symptom Assessment and Classification of Pain, Depression and Physical Function (Cachexia) (EPCRC - CSA)

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

Patients

  • Cachexia
  • Depression
  • Pain
  • Unspecified Adult Solid Tumor, Protocol Specific
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1051
December 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00972634
CDR0000648077, NUST-EPCRC-CSA, EU-20962
No
Norwegian University of Science and Technology
Norwegian University of Science and Technology
Not Provided
Principal Investigator: Stein Kaasa, MD Norwegian University of Science and Technology
Norwegian University of Science and Technology
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP