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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The European Palliative Care Research Collaborative - Computerised Symptom Assessment and Classification of Pain, Depression and Physical Function (Cachexia) (EPCRC - CSA)

Conditions
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Cachexia, Depression, Pain, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Other: computer-assisted intervention
* Other: questionnaire administration
* Procedure: assessment of therapy complications
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, cachexia, pain, unspecified adult solid tumor, protocol specific