CachexiaNCT00972634
Computerized Questionnaires in Assessing Symptoms, Pain, Depression, and Physical Function in Patients With Metastatic and/or Advanced Locoregional Cancer
An observational study of Cachexia and Depression, run by Norwegian University of Science and Technology at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cachexia, Depression, Pain
- What is being tested?
- computer-assisted intervention, questionnaire administration and assessment of therapy complications
- Type of treatment
- Surgery or procedure
- How many people
- 1,051 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2008to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- computer-assisted intervention, questionnaire administration, assessment of therapy complications, quality-of-life assessment
- Keywords
- depression, cachexia, pain, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Cachexia, Depression, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computer-assisted interventionOther
symptom assessment
questionnaire administrationOther
Symptom assessment
assessment of therapy complicationsProcedure or surgery
Symptom assessment
quality-of-life assessmentProcedure or surgery
Symptom assessment
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of applying a computer based system for symptom assessment and classification in palliative cancer care
Measured: Sept 2008-December 2009
Differences across groups related to acceptance of computers (i.e., age, culture, stage of disease, cognitive and physical function, etc.)
Measured: Sept 2008-December 2009
General user-friendliness of the tool
Measured: Sept 2008-December 2009
Performance of selected domains and items for classification and assessment of pain and cachexia
Measured: Sept 2008-December 2009
Validity of domains and items for depression
Measured: Sept 2008-December 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2009 (estimated)
- Study startOct 2008
- Primary completionNov 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CachexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,051 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stein Kaasa, MD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972634
- Sponsor's protocol ID
- CDR0000648077
- Other IDs
- NUST-EPCRC-CSA, EU-20962
- Status last verified
- Jan 2017
- First submitted
- 4 Sep 2009
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22795905Hjermstad 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.
PubMed 27342412
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The European Palliative Care Research Collaborative - Computerised Symptom Assessment and Classification of Pain, Depression and Physical Function (Cachexia) (EPCRC - CSA)
- ClinicalTrials.gov ID
- NCT00972634
- Acronym / sponsor ID
- CDR0000648077
- Keywords
- depression, cachexia, pain, unspecified adult solid tumor, protocol specific
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,051 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 7 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| computer-assisted interventionsymptom assessment | Other | – |
| questionnaire administrationSymptom assessment | Other | – |
| assessment of therapy complicationsSymptom assessment | Procedure or surgery | – |
| quality-of-life assessmentSymptom assessment | Procedure or surgery | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Results publication: PubMed 22795905Hjermstad 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.
- Derived from this study: PubMed 27342412Hjermstad 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stein Kaasa, MD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cachexia and Depression, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of applying a computer based system for symptom assessment and classification in palliative cancer care (time frame: Sept 2008-December 2009). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00972634, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2017.