Computerized Questionnaires in Assessing Symptoms, Pain, Depression, and Physical Function in Patients With Metastatic and/or Advanced Locoregional Cancer
NCT ID: NCT00972634
Last Updated: 2017-01-18
Study Results
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Basic Information
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COMPLETED
1051 participants
OBSERVATIONAL
2008-10-31
2009-12-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Interventions
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computer-assisted intervention
symptom assessment
questionnaire administration
Symptom assessment
assessment of therapy complications
Symptom assessment
quality-of-life assessment
Symptom assessment
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Norwegian University of Science and Technology
OTHER
Responsible Party
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Principal Investigators
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Stein Kaasa, MD
Role: PRINCIPAL_INVESTIGATOR
Norwegian University of Science and Technology
Locations
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Norwegian University of Science and Technology
Trondheim, , Norway
Countries
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References
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Hjermstad MJ, Lie HC, Caraceni A, Currow DC, Fainsinger RL, Gundersen OE, Haugen DF, Heitzer E, Radbruch L, Stone PC, Strasser F, Kaasa S, Loge JH; European Palliative Care Research Collaborative (EPCRC). Computer-based symptom assessment is feasible in patients with advanced cancer: results from an international multicenter study, the EPCRC-CSA. J Pain Symptom Manage. 2012 Nov;44(5):639-54. doi: 10.1016/j.jpainsymman.2011.10.025. Epub 2012 Jul 13.
Hjermstad MJ, Kaasa S, Caraceni A, Loge JH, Pedersen T, Haugen DF, Aass N; European Palliative Care Research Collaborative (EPCRC). Characteristics of breakthrough cancer pain and its influence on quality of life in an international cohort of patients with cancer. BMJ Support Palliat Care. 2016 Sep;6(3):344-52. doi: 10.1136/bmjspcare-2015-000887. Epub 2016 Jun 24.
Other Identifiers
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NUST-EPCRC-CSA
Identifier Type: -
Identifier Source: secondary_id
EU-20962
Identifier Type: -
Identifier Source: secondary_id
CDR0000648077
Identifier Type: -
Identifier Source: org_study_id
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