Characterisation and Epidemiology of Breakthrough Cancer Pain in Spain
2 other identifiers
observational
3,765
1 country
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2016
36 active sites
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
First Submitted
Initial submission to the registry
September 9, 2016
CompletedFirst Posted
Study publicly available on registry
September 14, 2016
CompletedStudy Start
First participant enrolled
November 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 16, 2018
CompletedResults Posted
Study results publicly available
November 22, 2019
CompletedNovember 22, 2019
November 1, 2019
1.4 years
September 9, 2016
July 11, 2019
November 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Cancer Participants With Breakthrough Cancer Pain From the Total Number of Cancer Participants Seen in Consultation
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.
Month 1
Percentage of Cancer Participants With Breakthrough Cancer Pain From the Number of Cancer Participants With Pain Seen in Consultation
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.
Month 1
Secondary Outcomes (7)
Number of New Participants Diagnosed With Breakthrough Cancer Pain From the Total Number of Cancer Participants Seen in Consultation
Month 1
Percentage of New Participants Diagnosed With Breakthrough Cancer Pain From the Number of Cancer Participants With Pain Seen in Consultation
Month 1
Pain Characterization With the Alberta Breakthrough Pain Assessment
Month 1
Pain Severity and Pain Interference as Assessed by Brief Pain Inventory (BPI) Questionnaire Score
Month 1
Pain Assessment Using the Numeric Rating Scale
Month 1
- +2 more secondary outcomes
Study Arms (1)
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
Eligibility Criteria
Participants with cancer pain will be included in the study.
You may qualify if:
- 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
- Signing of the informed consent
You may not qualify if:
- Severe mental illness
- Any medical condition or situation complicating the collection of study data as determined by the investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (36)
Hospital General Universitario de Elda-Virgen de La Salud
Elda, Alicante, 3600, Spain
Hospital Universitario San Juan de Alicante
San Juan, Alicante, 3550, Spain
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, 7120, Spain
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, 7198, Spain
Hospital Universitari Germans Trias I Pujol de Badalona
Badalona, Barcelona, 08916, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 8907, Spain
Hospital de Especialidades de Puerto Real
Puerto Real, Cadiz, 11510, Spain
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, Canary Islands, 35010, Spain
Complejo Hospitalario Universitario Insular-Materno Infantil
Las Palmas de Gran Canarias, Canary Islands, 35001, Spain
Hospital Universitario Nuestra Senora de Candelaria
Santa Cruz de Tenerife, Canary Islands, 38010, Spain
Hospital de Alta Resolucion de Guadix
Guadix, Granada, 18500, Spain
Hospital Universitario Principe de Asturias
Alcalá de Henares, Madrid, 28805, Spain
Hospital Universitario Puerta de Hierro, Majadahonda
Majadahonda, Madrid, 28222, Spain
Hospital Quiron Madrid
Pozuelo de Alarcón, Madrid, 28223, Spain
Complejo Hospital Costa Del Sol
Marbella, Malaga, 29603, Spain
Hospital General Universitario Santa Lucia
Cartagena, Murcia, 30202, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, 31008., Spain
Hospital Los Montalvos
Carrascal de Barregas, Salamanca, 37197, Spain
Complexo Hospitalario Universitario A Coruna
A Coruña, 15006, Spain
Centro Oncoloxico de Galicia
A Coruña, 15009, Spain
Hospital Torrecardenas
Almería, 4009, Spain
Hospital Puerta Del Mar
Cadiz, 11009, Spain
Hospital Reina Sofia
Córdoba, 14004, Spain
Hospital Universitario Virgen de Las Nieves
Granada, 18014, Spain
Complejo Hospitalario de Jaen
Jaén, 23007, Spain
Hospital Universitario de La Princesa
Madrid, 28006, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Complejo Hospitalario Regional de Malaga
Málaga, 29010, Spain
Hospital Virgen de La Victoria
Málaga, 29010, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Nuestra Senora de Valme
Seville, 41014, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Hospital General Universitario de Valencia
Valencia, 46014, Spain
Hospital Universitario Doctor Peset
Valencia, 46017, Spain
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Director Clinical Science
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2016
First Posted
September 14, 2016
Study Start
November 14, 2016
Primary Completion
April 4, 2018
Study Completion
July 16, 2018
Last Updated
November 22, 2019
Results First Posted
November 22, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will share
Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.