---
title: Characterisation and Epidemiology of Breakthrough Cancer Pain in Spain
nct_id: NCT02899884
overall_status: COMPLETED
sponsor: Takeda
study_type: OBSERVATIONAL
primary_condition: Breakthrough Cancer Pain
countries: Spain
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02899884.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02899884"
ct_last_update_post_date: 2019-11-22
last_seen_at: "2026-05-12T06:41:59.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Characterisation and Epidemiology of Breakthrough Cancer Pain in Spain

**NCT ID:** [NCT02899884](https://clinicaltrials.gov/study/NCT02899884)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 3765
- **Lead Sponsor:** Takeda
- **Conditions:** Breakthrough Cancer Pain
- **Start Date:** 2016-11-14
- **Completion Date:** 2018-07-16
- **CT.gov Last Update:** 2019-11-22

## Brief Summary

The purpose of this study is to determine the prevalence of breakthrough cancer pain and characterize breakthrough cancer pain in an unselected, representative cohort of cancer outpatients with or without pain who attend consultations.

## Detailed Description

This study has been designed as a non-interventional, non post-authorization, cross-sectional, epidemiological study to determine the prevalence of breakthrough cancer pain and characterize breakthrough cancer pain in an non-selected, representative cohort of cancer outpatients with or without pain.

The study enrolled 3765 patients. This multicenter trial will be conducted in Spain. Data from participants will be collected through questionnaire and medical history in a single visit (up to 1 month).

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Participants≥ 18 years old
* Participants with baseline cancer pain that is adequately controlled with opioids
* Presence of episodes of breakthrough pain associated with the cancer pain
* Meeting the diagnostic criteria for breakthrough cancer pain (participant history and Portenoy's criteria) and the Davies algorithm
* Participants who are not receiving treatment for breakthrough cancer pain. It is not permitted the inclusion of participants receiving treatment for breakthrough cancer pain in order to avoid bias that may affect the characterization or taxonomy of breakthrough cancer pain
* Signing of the informed consent

Exclusion Criteria:

* Severe mental illness
* Any medical condition or situation complicating the collection of study data as determined by the investigator
```

## Arms

- **Cohort 1** — Participants with cancer pain that is adequately controlled with opioids were observed for a period of 1 month in this observational study.

## Interventions

- **No Intervention** (OTHER)

## Primary Outcomes

- **Percentage of Cancer Participants With Breakthrough Cancer Pain From the Total Number of Cancer Participants Seen in Consultation** _(time frame: Month 1)_ — Breakthrough cancer pain was defined as the temporary exacerbation of pain occurring either spontaneously or in relation to a specific, predictable or unpredictable trigger in spite of relatively stable and adequately controlled baseline pain.
- **Percentage of Cancer Participants With Breakthrough Cancer Pain From the Number of Cancer Participants With Pain Seen in Consultation** _(time frame: Month 1)_ — Breakthrough cancer pain was defined as the temporary exacerbation of pain occurring either spontaneously or in relation to a specific, predictable or unpredictable trigger in spite of relatively stable and adequately controlled baseline pain.

## Secondary Outcomes

- **Number of New Participants Diagnosed With Breakthrough Cancer Pain From the Total Number of Cancer Participants Seen in Consultation** _(time frame: Month 1)_
- **Percentage of New Participants Diagnosed With Breakthrough Cancer Pain From the Number of Cancer Participants With Pain Seen in Consultation** _(time frame: Month 1)_
- **Pain Characterization With the Alberta Breakthrough Pain Assessment** _(time frame: Month 1)_
- **Pain Severity and Pain Interference as Assessed by Brief Pain Inventory (BPI) Questionnaire Score** _(time frame: Month 1)_
- **Pain Assessment Using the Numeric Rating Scale** _(time frame: Month 1)_
- **Quality of Life Assessment Using the Short Form-12 (SF-12) Questionnaire Score** _(time frame: Month 1)_
- **Participant's Performance as Assessed by the Karnofsky Scale Score** _(time frame: Month 1)_

## Locations (36)

- Hospital General Universitario de Elda-Virgen de La Salud, Elda, Alicante, Spain
- Hospital Universitario San Juan de Alicante, San Juan, Alicante, Spain
- Hospital Universitari Son Espases, Palma de Mallorca, Balearic Islands, Spain
- Hospital Son Llatzer, Palma de Mallorca, Balearic Islands, Spain
- Hospital Universitari Germans Trias I Pujol de Badalona, Badalona, Barcelona, Spain
- Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain
- Hospital de Especialidades de Puerto Real, Puerto Real, Cadiz, Spain
- Hospital Universitario de Gran Canaria Dr. Negrin, Las Palmas de Gran Canaria, Canary Islands, Spain
- Complejo Hospitalario Universitario Insular-Materno Infantil, Las Palmas de Gran Canarias, Canary Islands, Spain
- Hospital Universitario Nuestra Senora de Candelaria, Santa Cruz de Tenerife, Canary Islands, Spain
- Hospital de Alta Resolucion de Guadix, Guadix, Granada, Spain
- Hospital Universitario Principe de Asturias, Alcalá de Henares, Madrid, Spain
- Hospital Universitario Puerta de Hierro, Majadahonda, Majadahonda, Madrid, Spain
- Hospital Quiron Madrid, Pozuelo de Alarcón, Madrid, Spain
- Complejo Hospital Costa Del Sol, Marbella, Malaga, Spain
- Hospital General Universitario Santa Lucia, Cartagena, Murcia, Spain
- Clinica Universidad de Navarra, Pamplona, Navarre, Spain
- Hospital Los Montalvos, Carrascal de Barregas, Salamanca, Spain
- Complexo Hospitalario Universitario A Coruna, A Coruña, Spain
- Centro Oncoloxico de Galicia, A Coruña, Spain
- Hospital Torrecardenas, Almería, Spain
- Hospital Puerta Del Mar, Cadiz, Spain
- Hospital Reina Sofia, Córdoba, Spain
- Hospital Universitario Virgen de Las Nieves, Granada, Spain
- Complejo Hospitalario de Jaen, Jaén, Spain
- Hospital Universitario de La Princesa, Madrid, Spain
- Hospital Universitario Fundacion Jimenez Diaz, Madrid, Spain
- Hospital Universitario 12 de Octubre, Madrid, Spain
- Hospital Universitario La Paz, Madrid, Spain
- Complejo Hospitalario Regional de Malaga, Málaga, Spain
- Hospital Virgen de La Victoria, Málaga, Spain
- Hospital Universitario de Salamanca, Salamanca, Spain
- Hospital Nuestra Senora de Valme, Seville, Spain
- Hospital Clinico Universitario de Valencia, Valencia, Spain
- Hospital General Universitario de Valencia, Valencia, Spain
- Hospital Universitario Doctor Peset, Valencia, Spain

## Recent Field Changes (last 30 days)

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---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02899884.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02899884*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*