Characterisation and Epidemiology of Breakthrough Cancer Pain in Spain

Completed

• Conditions: Breakthrough Cancer Pain
• Interventions: Other: No Intervention

• Registration Number: NCT02899884
• Lead Sponsor: Takeda

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).

Study Timeline

• Study First Submitted: 2016-09-09
• Study First Submitted QC: 2016-09-09
• Study First Posted: 2016-09-14
• Study Start: 2016-11-14
• Primary Completion: 2018-04-04
• Study Completion: 2018-07-16
• Results First Submitted: 2019-07-11
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-20
• Last Update Submitted: 2019-11-20
• Results First Posted: 2019-11-22
• Last Update Posted: 2019-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3765

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of Cancer Participants With Breakthrough Cancer Pain From the Number of Cancer Participants With Pain Seen in Consultation	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 Total Number of Cancer Participants Seen in Consultation	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 Outcome Measures

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

Trial Locations

Locations (36)

Hospital Universitario San Juan de Alicante; 🇪🇸 San Juan, Alicante, Spain

Hospital General Universitario de Elda-Virgen de La Salud; 🇪🇸 Elda, Alicante, Spain

Hospital Universitari Son Espases; 🇪🇸 Palma de Mallorca, Baleares, Spain

Hospital de Especialidades de Puerto Real; 🇪🇸 Puerto Real, Cadiz, Spain

Hospital Universitari Germans Trias I Pujol de Badalona; 🇪🇸 Badalona, Barcelona, Spain

Hospital Son Llatzer; 🇪🇸 Palma de Mallorca, Baleares, Spain

Complejo Hospitalario Universitario Insular-Materno Infantil; 🇪🇸 Las Palmas De Gran Canarias, Canarias, Spain

Hospital Universitari de Bellvitge; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain

Hospital de Alta Resolucion de Guadix; 🇪🇸 Guadix, Granada, Spain

Hospital Universitario de Gran Canaria Dr. Negrin; 🇪🇸 Las Palmas de Gran Canaria, Canarias, Spain

Hospital Universitario Nuestra Senora de Candelaria; 🇪🇸 Santa Cruz de Tenerife, Canarias, Spain

Hospital Universitario Principe de Asturias; 🇪🇸 Alcala de Henares, Madrid, Spain

Hospital Quiron Madrid; 🇪🇸 Pozuelo de Alarcon, Madrid, Spain

Complejo Hospital Costa Del Sol; 🇪🇸 Marbella,, Malaga, Spain

Hospital Universitario Puerta de Hierro, Majadahonda; 🇪🇸 Majadahonda, Madrid, Spain

Hospital General Universitario Santa Lucia; 🇪🇸 Cartagena, Murcia, Spain

Complexo Hospitalario Universitario A Coruna; 🇪🇸 A Coruna, Spain

Hospital Los Montalvos; 🇪🇸 Carrascal de Barregas,, Salamanca, Spain

Centro Oncoloxico de Galicia; 🇪🇸 A Coruna, Spain

Hospital Torrecardenas; 🇪🇸 Almeria, Spain

Hospital Puerta Del Mar; 🇪🇸 Cadiz, Spain

Hospital Reina Sofia; 🇪🇸 Cordoba, Spain

Hospital Universitario Virgen de Las Nieves; 🇪🇸 Granada, Spain

Complejo Hospitalario de Jaen; 🇪🇸 Jaen, 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; 🇪🇸 Malaga, Spain

Hospital Virgen de La Victoria; 🇪🇸 Malaga, Spain

Hospital Universitario de Salamanca; 🇪🇸 Salamanca, Spain

Hospital General Universitario de Valencia; 🇪🇸 Valencia, Spain

Hospital Universitario Doctor Peset; 🇪🇸 Valencia, Spain

Hospital Nuestra Senora de Valme; 🇪🇸 Sevilla, Spain

Hospital Clinico Universitario de Valencia; 🇪🇸 Valencia, Spain

Clinica Universidad de Navarra; 🇪🇸 Pamplona, Navarra, Spain