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van CCT (UK)

van CCT (UK)

Validation of the Breakthrough Assessment Tool

- candidate number28665
- NTR NumberNTR7062
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-mrt-2018
- Secondary IDsMEC-2013-056 
- Public TitleValidation of the Breakthrough Assessment Tool
- Scientific TitleValidation study of an assessment tool for Breakthrough Cancer Pain
- hypothesisThe Dutch version of the Breakthrough pain Assessment Tool (BAT) is a valid and reliable questionnaire to measure differences in breakthrough pain in patients with cancer
- Healt Condition(s) or Problem(s) studiedCancer, Pain, Break through pain
- Inclusion criteria1. patients with a pathologically confirmed diagnosis of cancer
2. patients must be 18 years of age or older
3. pain due to cancer or its treatment
4. patients took regular scheduled analgesia in the previous week
5. patients considered to have breakthrough pain according a 'clinical expert'
6. patients must have taken at least one dose of 'rescue' medication for a breakthrough episode in the previous week
7. cognitive status sufficient for accurate completion of the study
8. ability to provide written informed consent
- Exclusion criteria1. patients who cannot understand the intent of the study, in their physician's estimation
2. patients whose performance status is felt to be too poor to allow them to complete the survey
3. patients who refuse to participate
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2016
- planned closingdate31-dec-2018
- Target number of participants200
- Interventionsall patients complete the study questionnaire 4 times within a two week timeframe.
- Primary outcomeContruct validity of the third questionnaire compared to the first questionnaire
- Secondary outcome- pain evaluation
- face and content validity
- reliability
- responsiveness to change
- acceptability
- TimepointsT0 = at baseline
T1 = 24 hrs after baseline
T2 = 1 week after baseline
T3 = 1 week after T1
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Rotterdam, InnovatieFonds
- Publicationsn/a
- Brief summaryIn patients with cancer, pain is one of the most frequent and feared symptoms. Pain can interfere with all aspects of daily life and pain intensity is an important component of patientsf quality of life. Usually, patients experience fluctuations in their pain intensity. In most patients, pain has continuous and a variable components. The continuous component is mostly referred to as ebackground painf. The variable component of pain is usually described as ebreakthrough painf. Successful management of breakthrough pain depends on adequate assessment, appropriate treatment and adequate reassessment. A number of tools have been developed for the assessment of cancer]related pain. These tools mainly focus on the background pain and most tools provide only little information about the breakthrough pain. Recently, a new assessment tool has been developed for daily practice, the Breakthrough pain Assessment Tool (BAT). The BAT was validated in a group of 100 English cancer patients. After this first validation in an English population of cancer patients (in all stages of the disease), this assessment tool for breakthrough pain seems to be a validated and reliable questionnaire for daily practice. Therefore, the BAT is the preferred breakthrough assessment tool to be used in the Netherlands.
In this study we will:
1. Translate the BAT into Dutch according the EORTC translation guidelines
2. Validate the BAT]Dutch language version in cancer patients with breakthrough pain
- Main changes (audit trail)
- RECORD1-mrt-2018 - 13-mrt-2018

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