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Validation of the Breakthrough Assessment Tool

Validation study of an assessment tool for Breakthrough Cancer Pain

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON23176
Enrollment
200
Registered
2018-03-01
Start date
2016-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, pain, breakthrough pain

Interventions

all patients complete the study questionnaire 4 times within a two week timeframe.

Sponsors

Erasmus Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Contruct validity of the third questionnaire compared to the first questionnaire

Secondary

MeasureTime frame
- pain evaluation - face and content validity - reliability - responsiveness to change - acceptability

Contacts

Public ContactW.H. Oldenmenger

Erasmus Medical Center, Daniel den Hoed Cancer Center, P.O. Box 5201

w.h.oldenmenger@erasmusmc.nl+31 (0)10 4391439

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)