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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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00972634
Enrollment
1051
Registered
2009-09-07
Start date
2008-10-31
Completion date
2009-12-31
Last updated
2017-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

depression, cachexia, pain, unspecified adult solid tumor, protocol specific

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.

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.

Interventions

symptom assessment

OTHERquestionnaire administration

Symptom assessment

PROCEDUREassessment of therapy complications

Symptom assessment

PROCEDUREquality-of-life assessment

Symptom assessment

Sponsors

Norwegian University of Science and Technology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Feasibility of applying a computer based system for symptom assessment and classification in palliative cancer careSept 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 toolSept 2008-December 2009
Performance of selected domains and items for classification and assessment of pain and cachexiaSept 2008-December 2009
Validity of domains and items for depressionSept 2008-December 2009

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026