No registrations found.
ID
Source
Health condition
Cancer, pain, breakthrough pain
Sponsors and support
Intervention
Outcome measures
Primary outcome
Contruct validity of the third questionnaire compared to the first questionnaire
Secondary outcome
- pain evaluation
- face and content validity
- reliability
- responsiveness to change
- acceptability
Background summary
In 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 patientsf 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 painf. The variable component of pain is usually described as ebreakthrough painf. 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
Study objective
The 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
Study design
T0 = at baseline
T1 = 24 hrs after baseline
T2 = 1 week after baseline
T3 = 1 week after T1
Intervention
all patients complete the study questionnaire 4 times within a two week timeframe.
W.H. Oldenmenger
Rotterdam 3008 AE
The Netherlands
+31 (0)10 4391439
w.h.oldenmenger@erasmusmc.nl
W.H. Oldenmenger
Rotterdam 3008 AE
The Netherlands
+31 (0)10 4391439
w.h.oldenmenger@erasmusmc.nl
Inclusion criteria
1. 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 criteria
1. 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6884 |
| NTR-old | NTR7062 |
| Other | : MEC-2013-056 |