Clinical trial NCT02899884: Characterisation and Epidemiology of Breakthrough Cancer Pain in Spain
Official title: Characterisation and Epidemiology of Breakthrough Cancer Pain in Spain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breakthrough Cancer Pain
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2016-09-14
Enrollment: 3765
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with cancer pain will be included in the study.

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 criteria: 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

Primary outcomes:
measure: Percentage of Cancer Participants With Breakthrough Cancer Pain From the Total Number of Cancer Participants Seen in Consultation
timeFrame: Month 1
measure: Percentage of Cancer Participants With Breakthrough Cancer Pain From the Number of Cancer Participants With Pain Seen in Consultation
timeFrame: Month 1
Secondary outcomes:
measure: Number of New Participants Diagnosed With Breakthrough Cancer Pain From the Total Number of Cancer Participants Seen in Consultation
timeFrame: Month 1
measure: Percentage of New Participants Diagnosed With Breakthrough Cancer Pain From the Number of Cancer Participants With Pain Seen in Consultation
timeFrame: Month 1
measure: Pain Characterization With the Alberta Breakthrough Pain Assessment
timeFrame: Month 1
measure: Pain Severity and Pain Interference as Assessed by Brief Pain Inventory (BPI) Questionnaire Score
timeFrame: Month 1
measure: Pain Assessment Using the Numeric Rating Scale
timeFrame: Month 1
measure: Quality of Life Assessment Using the Short Form-12 (SF-12) Questionnaire Score
timeFrame: Month 1
measure: Participant's Performance as Assessed by the Karnofsky Scale Score
timeFrame: Month 1
Other outcomes:
Locations:
city: Elda
country: Spain
facility: Hospital General Universitario de Elda-Virgen de La Salud
state: Alicante
city: San Juan
country: Spain
facility: Hospital Universitario San Juan de Alicante
state: Alicante
city: Palma de Mallorca
country: Spain
facility: Hospital Universitari Son Espases
state: Baleares
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llatzer
state: Baleares
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias I Pujol de Badalona
state: Barcelona
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Puerto Real
country: Spain
facility: Hospital de Especialidades de Puerto Real
state: Cadiz
city: Las Palmas De Gran Canarias
country: Spain
facility: Complejo Hospitalario Universitario Insular-Materno Infantil
state: Canarias
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Dr. Negrin
state: Canarias
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario Nuestra Senora de Candelaria
state: Canarias
city: Guadix
country: Spain
facility: Hospital de Alta Resolucion de Guadix
state: Granada
city: Alcala de Henares
country: Spain
facility: Hospital Universitario Principe de Asturias
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro, Majadahonda
state: Madrid
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Quiron Madrid
state: Madrid
city: Marbella,
country: Spain
facility: Complejo Hospital Costa Del Sol
state: Malaga
city: Cartagena
country: Spain
facility: Hospital General Universitario Santa Lucia
state: Murcia
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
city: Carrascal de Barregas,
country: Spain
facility: Hospital Los Montalvos
state: Salamanca
city: A Coruna
country: Spain
facility: Complexo Hospitalario Universitario A Coruna
city: A Coruna
country: Spain
facility: Centro Oncoloxico de Galicia
city: Almeria
country: Spain
facility: Hospital Torrecardenas
city: Cadiz
country: Spain
facility: Hospital Puerta Del Mar
city: Cordoba
country: Spain
facility: Hospital Reina Sofia
city: Granada
country: Spain
facility: Hospital Universitario Virgen de Las Nieves
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaen
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Malaga
country: Spain
facility: Complejo Hospitalario Regional de Malaga
city: Malaga
country: Spain
facility: Hospital Virgen de La Victoria
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Nuestra Senora de Valme
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset
Study officials:
affiliation: Takeda
name: Medical Director Clinical Science
role: STUDY_DIRECTOR
References: