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

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ClinicalTrials.gov Identifier: NCT00972634
Recruitment Status : Completed
First Posted : September 7, 2009
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Tracking Information
First Submitted Date September 4, 2009
First Posted Date September 7, 2009
Last Update Posted Date January 18, 2017
Study Start Date October 2008
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 28, 2011)
  • Feasibility of applying a computer based system for symptom assessment and classification in palliative cancer care [ Time Frame: Sept 2008-December 2009 ]
  • 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 ]
  • General user-friendliness of the tool [ Time Frame: Sept 2008-December 2009 ]
  • Performance of selected domains and items for classification and assessment of pain and cachexia [ Time Frame: Sept 2008-December 2009 ]
  • Validity of domains and items for depression [ Time Frame: Sept 2008-December 2009 ]
Original Primary Outcome Measures
 (submitted: September 4, 2009)
  • Feasibility of applying a computer based system for symptom assessment and classification in palliative cancer care
  • Differences across groups related to acceptance of computers (i.e., age, culture, stage of disease, cognitive, and physical function)
  • General user-friendliness of the tool
  • Performance of selected domains and items for classification and assessment of pain and cachexia
  • Validity of domains and items for depression
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Computerized Questionnaires in Assessing Symptoms, Pain, Depression, and Physical Function in Patients With Metastatic and/or Advanced Locoregional Cancer
Official Title The European Palliative Care Research Collaborative - Computerised Symptom Assessment and Classification of Pain, Depression and Physical Function (Cachexia) (EPCRC - CSA)
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients
Condition
  • Cachexia
  • Depression
  • Pain
  • Unspecified Adult Solid Tumor, Protocol Specific
Intervention
  • Other: computer-assisted intervention
    symptom assessment
  • Other: questionnaire administration
    Symptom assessment
  • Procedure: assessment of therapy complications
    Symptom assessment
  • Procedure: quality-of-life assessment
    Symptom assessment
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 28, 2011)
1051
Original Estimated Enrollment
 (submitted: September 4, 2009)
1200
Actual Study Completion Date December 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT00972634
Other Study ID Numbers CDR0000648077
NUST-EPCRC-CSA
EU-20962
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Norwegian University of Science and Technology
Study Sponsor Norwegian University of Science and Technology
Collaborators Not Provided
Investigators
Principal Investigator: Stein Kaasa, MD Norwegian University of Science and Technology
PRS Account Norwegian University of Science and Technology
Verification Date January 2017