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

Sponsor

Norwegian University of Science and Technology (Other)

Overall Status

Completed

CT.gov ID

NCT00972634

Collaborator

(none)

1,051

Enrollment

Location

Duration (Months)

75.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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	Phase
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

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.

Study Design

Study Type:

Observational

Actual Enrollment :

1051 participants

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)

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Nov 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Outcome Measures

Primary Outcome Measures

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]