Computerized Questionnaires in Assessing Symptoms, Pain, Depression, and Physical Function in Patients With Metastatic and/or Advanced Locoregional Cancer
|ClinicalTrials.gov Identifier: NCT00972634|
Recruitment Status : Completed
First Posted : September 7, 2009
Last Update Posted : January 18, 2017
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 or disease||Intervention/treatment|
|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|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||1051 participants|
|Official Title:||The European Palliative Care Research Collaborative - Computerised Symptom Assessment and Classification of Pain, Depression and Physical Function (Cachexia) (EPCRC - CSA)|
|Study Start Date :||October 2008|
|Primary Completion Date :||November 2009|
|Study Completion Date :||December 2009|
Other: computer-assisted intervention
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00972634
|Norwegian University of Science and Technology|
|Trondheim, Norway, N-7006|
|Principal Investigator:||Stein Kaasa, MD||Norwegian University of Science and Technology|