Characterisation and Epidemiology of Breakthrough Cancer Pain in Spain

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.

Study Overview

• Status: Completed
• Conditions: Breakthrough Cancer Pain
• Intervention / Treatment: Other: No Intervention

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).

• Study Type: Observational
• Enrollment (Actual): 3765

Contacts and Locations

Study Locations

• Spain
  • A Coruna, Spain, 15006
    • Complexo Hospitalario Universitario A Coruña
  • A Coruna, Spain, 15009
    • Centro Oncoloxico de Galicia
  • Almeria, Spain, 4009
    • Hospital Torrecardenas
  • Cadiz, Spain, 11009
    • Hospital Puerta del Mar
  • Cordoba, Spain, 14004
    • Hospital Reina Sofia
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de las Nieves
  • Jaen, Spain, 23007
    • Complejo Hospitalario de Jaen
  • Madrid, Spain, 28040
    • Hospital Universitario Fundación Jiménez Díaz
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28006
    • Hospital Universitario de la Princesa
  • Malaga, Spain, 29010
    • Hospital Virgen de la Victoria
  • Malaga, Spain, 29010
    • Complejo Hospitalario Regional de Málaga
  • Salamanca, Spain, 37007
    • Hospital Universitario de Salamanca
  • Sevilla, Spain, 41014
    • Hospital Nuestra Señora de Valme
  • Valencia, Spain, 46010
    • Hospital Clínico Universitario de Valencia
  • Valencia, Spain, 46017
    • Hospital Universitario Doctor Peset
  • Valencia, Spain, 46014
    • Hospital General Universitario de Valencia
  • Alicante
    • Elda, Alicante, Spain, 3600
      • Hospital General Universitario de Elda-Virgen de La Salud
    • San Juan, Alicante, Spain, 3550
      • Hospital Universitario San Juan de Alicante
  • Baleares
    • Palma de Mallorca, Baleares, Spain, 7198
      • Hospital Son Llatzer
    • Palma de Mallorca, Baleares, Spain, 7120
      • Hospital Universitari Son Espases
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitari Germans Trias I Pujol de Badalona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 8907
      • Hospital Universitari de Bellvitge
  • Cadiz
    • Puerto Real, Cadiz, Spain, 11510
      • Hospital de Especialidades de Puerto Real
  • Canarias
    • Las Palmas De Gran Canarias, Canarias, Spain, 35001
      • Complejo hospitalario Universitario Insular-Materno Infantil
    • Las Palmas de Gran Canaria, Canarias, Spain, 35010
      • Hospital Universitario De Gran Canaria Dr. Negrin
    • Santa Cruz de Tenerife, Canarias, Spain, 38010
      • Hospital Universitario Nuestra Señora de Candelaria
  • Granada
    • Guadix, Granada, Spain, 18500
      • Hospital de Alta Resolucion de Guadix
  • Madrid
    • Alcala de Henares, Madrid, Spain, 28805
      • Hospital Universitario Príncipe de Asturias
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro, Majadahonda
    • Pozuelo de Alarcon, Madrid, Spain, 28223
      • Hospital Quiron Madrid
  • Malaga
    • Marbella,, Malaga, Spain, 29603
      • Complejo Hospital Costa Del Sol
  • Murcia
    • Cartagena, Murcia, Spain, 30202
      • Hospital General Universitario Santa Lucia
  • Navarra
    • Pamplona, Navarra, Spain, 31008.
      • Clínica Universidad de Navarra
  • Salamanca
    • Carrascal de Barregas,, Salamanca, Spain, 37197
      • Hospital Los Montalvos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants with cancer pain will be included in the study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; Participants with cancer pain that is adequately controlled with opioids were observed for a period of 1 month in this observational study.	Other: No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Pain Assessment Using the Numeric Rating Scale		Month 1
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
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

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2016
• Primary Completion (Actual): April 4, 2018
• Study Completion (Actual): July 16, 2018

Study Registration Dates

• First Submitted: September 9, 2016
• First Submitted That Met QC Criteria: September 9, 2016
• First Posted (Estimate): September 14, 2016

Study Record Updates

• Last Update Posted (Actual): November 22, 2019
• Last Update Submitted That Met QC Criteria: November 20, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain
• Other Study ID Numbers: Fentanyl-5001; CARPEDIO Study (Other Identifier: Other)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No