Characterisation and Epidemiology of Breakthrough Cancer Pain in Spain

Breakthrough Cancer Pain Clinical Trial

Official title:

Characterisation and Epidemiology of Breakthrough Cancer Pain in Spain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02899884
• Other study ID #: Fentanyl-5001
• Secondary ID: CARPEDIO Study
• Status: Completed
• Start date: November 14, 2016
• Est. completion date: July 16, 2018

Study information

• Verified date: November 2019
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3765
• Est. completion date: July 16, 2018
• Est. primary completion date: April 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breakthrough Cancer Pain
• Cancer Pain

Intervention

Other:
• No Intervention

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of New Participants Diagnosed With Breakthrough Cancer Pain From the Total Number of Cancer Participants Seen in Consultation	Participants diagnosed during the study and were not diagnosed previously were reported as new participants with breakthrough cancer pain. 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	Percentage of New Participants Diagnosed With Breakthrough Cancer Pain From the Number of Cancer Participants With Pain Seen in Consultation	Participants diagnosed during the study and were not diagnosed previously were reported as new participants with breakthrough cancer pain. 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	Pain Characterization With the Alberta Breakthrough Pain Assessment	The Alberta Breakthrough Pain Assessment Tool (ABPAT) consisted of a participant's self-reporting section (15 questions) out of which 4 questions of the tool were not included as they were related to the treatment for breakthrough cancer pain. The questions included: Q1-Relationship to baseline pain, Q2a-Last time experienced, Q3b-Frequency, Q4b-Intensity of pain at peak, Q5-Location (most frequent - =5%), Q6-Quality (those present in =20%), Q7-Time from onset to peak intensity, Q8-Time from onset [take medication] to end of episode, Q9-Cause(s) (triggers) (Those present in =20%), Q10-Predictability, Q11-General relief (those present in ˜20% or more participants) and questions completed by nurse/physician (N/P), Q1-Etiology of breakthrough pain, Q2-Inferred pathophysiology of breakthrough pain. Percentage of participants were categorized into the answers for each of these questions.	Month 1
Secondary	Pain Severity and Pain Interference as Assessed by Brief Pain Inventory (BPI) Questionnaire Score	The BPI questionnaire was used to assess the pain intensity (4 items) and interference with activities of daily living (7 items). Each item was given a score on a numerical scale from 0 (no pain/interference with activities of daily living) to 10 (worst pain imaginable/maximum impact on activities of daily living). The total score for pain intensity is the average of the four pain items. The total score of pain interference is the average score of the seven interference items. The higher score represents high impact.	Month 1
Secondary	Pain Assessment Using the Numeric Rating Scale		Month 1
Secondary	Quality of Life Assessment Using the Short Form-12 (SF-12) Questionnaire Score	The SF-12 health questionnaire is a 12 question assessment of functional health and well-being. The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). Two summary measures are derived: the Physical and the Mental Health Component Summary. For each component summary, survey items were weighted and summed to create a summary score between 0 (poor mental and physical quality of life) and 100 (better mental and physical quality of life).	Month 1
Secondary	Participant's Performance as Assessed by the Karnofsky Scale Score	Karnofsky performance score is used to quantify participant's general well-being and activities of daily life and participants are classified based on their functional impairment. Karnofsky performance score is 11 level score which ranges between 0 (death) to 100 (participant asymptomatic with no evidence of illness). Higher score means higher ability to perform daily tasks. Participants with missing values in the Karnofsky scale were assigned to the worst score of 0, however, in these cases it is not 'death'.	Month 1