NCT00972634

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,051

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

1.1 years

First QC Date

September 4, 2009

Last Update Submit

January 16, 2017

Conditions

CachexiaDepressionPainUnspecified Adult Solid Tumor, Protocol Specific

Keywords

depressioncachexiapainunspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (5)

  • 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

Interventions

computer-assisted interventionOTHER

symptom assessment

questionnaire administrationOTHER

Symptom assessment

assessment of therapy complicationsPROCEDURE

Symptom assessment

quality-of-life assessmentPROCEDURE

Symptom assessment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Norwegian University of Science and Technology

Trondheim, N-7006, Norway

Location

Related Publications (2)

  • 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.

    PMID: 22795905RESULT

  • 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.

    PMID: 27342412DERIVED

MeSH Terms

Conditions

CachexiaDepressionPain

Condition Hierarchy (Ancestors)

Weight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinnessBehavioral SymptomsBehaviorNeurologic Manifestations

Study Officials

  • Stein Kaasa, MD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2009

First Posted

September 7, 2009

Study Start

October 1, 2008

Primary Completion

November 1, 2009

Study Completion

December 1, 2009

Last Updated

January 18, 2017

Record last verified: 2017-01

Locations

NO(1)