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OpenTrials
Completed

NCT Number: NCT00972634

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Norwegian University of Science and Technology

Trondheim, N-7006, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computer-Assisted Intervention

Other

symptom assessment

Questionnaire Administration

Other

Symptom assessment

assessment of therapy complications

Procedure

Symptom assessment

quality-of-life assessment

Procedure

Symptom assessment

Primary outcomes

  1. Feasibility of applying a computer based system for symptom assessment and classification in palliative cancer care

    Time frame: Sept 2008-December 2009

  2. 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

  3. General user-friendliness of the tool

    Time frame: Sept 2008-December 2009

  4. Performance of selected domains and items for classification and assessment of pain and cachexia

    Time frame: Sept 2008-December 2009

  5. Validity of domains and items for depression

    Time frame: Sept 2008-December 2009

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 7, 2009
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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