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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00972634
• Other study ID #: CDR0000648077
• Secondary ID: NUST-EPCRC-CSAEU
• Status: Completed
• Phase: N/A
• First received: September 4, 2009
• Last updated: January 16, 2017
• Start date: October 2008
• Est. completion date: December 2009

Study information

• Verified date: January 2017
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1051
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cachexia
• Depression
• Depressive Disorder
• Pain
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Other:
• computer-assisted intervention
symptom assessment
• questionnaire administration
Symptom assessment

Procedure:
• assessment of therapy complications
Symptom assessment
• quality-of-life assessment
Symptom assessment

Locations

Country	Name	City	State
Norway	Norwegian University of Science and Technology	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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 — View Citation

Outcome

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