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)

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.

Study Overview

• Status: Completed
• Conditions: Depression; Pain; Unspecified Adult Solid Tumor, Protocol Specific; Cachexia
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 1051

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway, N-7006
    • Norwegian University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Investigators: Principal Investigator: Stein Kaasa, MD, Norwegian University of Science and Technology

Publications and helpful links

General Publications

• 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 patients with advanced cancer: results from an international multicenter study, the EPCRC-CSA. J Pain Symptom Manage. 2012 Nov;44(5):639-54. doi: 10.1016/j.jpainsymman.2011.10.025. Epub 2012 Jul 13.
• Hjermstad MJ, Kaasa S, Caraceni A, Loge JH, Pedersen T, Haugen DF, Aass N; European Palliative Care Research Collaborative (EPCRC). Characteristics of breakthrough cancer pain and its influence on quality of life in an international cohort of patients with cancer. BMJ Support Palliat Care. 2016 Sep;6(3):344-52. doi: 10.1136/bmjspcare-2015-000887. Epub 2016 Jun 24.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: September 4, 2009
• First Submitted That Met QC Criteria: September 4, 2009
• First Posted (Estimate): September 7, 2009

Study Record Updates

• Last Update Posted (Estimate): January 18, 2017
• Last Update Submitted That Met QC Criteria: January 16, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: unspecified adult solid tumor, protocol specific; pain; depression; cachexia
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Metabolic Diseases; Mood Disorders; Nutrition Disorders; Body Weight; Body Weight Changes; Emaciation; Weight Loss; Depression; Depressive Disorder; Wasting Syndrome; Cachexia
• Other Study ID Numbers: CDR0000648077; NUST-EPCRC-CSA; EU-20962