Breakthrough Cancer PainNCT02899884
Characterisation and Epidemiology of Breakthrough Cancer Pain in Spain
An observational study of Breakthrough Cancer Pain, run by Takeda at 36 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breakthrough Cancer Pain
- How many people
- 3,765 participants
- Where
- 36 sitesSpain
- Study dates
- 14 Nov 2016to 16 Jul 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with cancer pain will be included in the study.
Who may be able to join
- 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
Who cannot join
- Severe mental illness
- Any medical condition or situation complicating the collection of study data as determined by the investigator
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
Spain36 sites
Complexo Hospitalario Universitario A Coruna
A Coruña, 15006
Centro Oncoloxico de Galicia
A Coruña, 15009
Hospital Universitario Principe de Asturias
Alcalá de Henares, Madrid, 28805
Hospital Torrecardenas
Almería, 4009
Hospital Universitari Germans Trias I Pujol de Badalona
Badalona, Barcelona, 08916
Hospital Puerta Del Mar
Cadiz, 11009
Hospital Los Montalvos
Carrascal de Barregas, Salamanca, 37197
Hospital General Universitario Santa Lucia
Cartagena, Murcia, 30202
Hospital Reina Sofia
Córdoba, 14004
Hospital General Universitario de Elda-Virgen de La Salud
Elda, Alicante, 3600
Hospital Universitario Virgen de Las Nieves
Granada, 18014
Hospital de Alta Resolucion de Guadix
Guadix, Granada, 18500
Complejo Hospitalario de Jaen
Jaén, 23007
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 8907
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, Canary Islands, 35010
Complejo Hospitalario Universitario Insular-Materno Infantil
Las Palmas de Gran Canarias, Canary Islands, 35001
Hospital Universitario de La Princesa
Madrid, 28006
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Puerta de Hierro, Majadahonda
Majadahonda, Madrid, 28222
Complejo Hospitalario Regional de Malaga
Málaga, 29010
Hospital Virgen de La Victoria
Málaga, 29010
Complejo Hospital Costa Del Sol
Marbella, Malaga, 29603
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, 7120
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, 7198
Clinica Universidad de Navarra
Pamplona, Navarre, 31008.
Hospital Quiron Madrid
Pozuelo de Alarcón, Madrid, 28223
Hospital de Especialidades de Puerto Real
Puerto Real, Cadiz, 11510
Hospital Universitario de Salamanca
Salamanca, 37007
Hospital Universitario San Juan de Alicante
San Juan, Alicante, 3550
Hospital Universitario Nuestra Senora de Candelaria
Santa Cruz de Tenerife, Canary Islands, 38010
Hospital Nuestra Senora de Valme
Seville, 41014
Hospital Clinico Universitario de Valencia
Valencia, 46010
Hospital General Universitario de Valencia
Valencia, 46014
Hospital Universitario Doctor Peset
Valencia, 46017
About this study
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.
Read the 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).
- Conditions
- Breakthrough Cancer Pain
- Being tested
- No Intervention
- Keywords
- Drug Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants with cancer pain that is adequately controlled with opioids were observed for a period of 1 month in this observational study. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Month 1
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 1
Pain Assessment Using the Numeric Rating Scale
Measured: 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).
Measured: 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'.
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study start14 Nov 2016
- Primary completion4 Apr 2018
- Study completion16 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breakthrough Cancer PainStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,765 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899884
- Sponsor's protocol ID
- Fentanyl-5001
- Other IDs
- CARPEDIO Study
- Status last verified
- Nov 2019
- First submitted
- 9 Sep 2016
- Last updated
- 22 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation and Epidemiology of Breakthrough Cancer Pain in Spain
- ClinicalTrials.gov ID
- NCT02899884
- Acronym / sponsor ID
- Fentanyl-5001
- Conditions
- Breakthrough Cancer Pain
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,765 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2016 (actual)
- Primary completion
- 4 Apr 2018 (actual)
- Study completion
- 16 Jul 2018 (actual)
- First posted
- 14 Sep 2016 (estimated)
- Results
- Posted 22 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: No InterventionParticipants with cancer pain that is adequately controlled with opioids were observed for a period of 1 month in this observational study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with cancer pain will be included in the study.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Severe mental illness
- Any medical condition or situation complicating the collection of study data as determined by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention | Other | Cohort 1 |
Primary outcome
Percentage of Cancer Participants With Breakthrough Cancer Pain From the Total Number of Cancer Participants Seen in Consultation
Time frame: 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 Number of Cancer Participants With Pain Seen in Consultation
Time frame: 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.
7 secondary outcomes
Number of New Participants Diagnosed With Breakthrough Cancer Pain From the Total Number of Cancer Participants Seen in Consultation
Time frame: Month 1
Percentage of New Participants Diagnosed With Breakthrough Cancer Pain From the Number of Cancer Participants With Pain Seen in Consultation
Time frame: Month 1
Pain Characterization With the Alberta Breakthrough Pain Assessment
Time frame: Month 1
Pain Severity and Pain Interference as Assessed by Brief Pain Inventory (BPI) Questionnaire Score
Time frame: Month 1
Pain Assessment Using the Numeric Rating Scale
Time frame: Month 1
Quality of Life Assessment Using the Short Form-12 (SF-12) Questionnaire Score
Time frame: Month 1
Participant's Performance as Assessed by the Karnofsky Scale Score
Time frame: Month 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Breakthrough Cancer Pain
Recruiting
Doxepin Solution for Alleviation of Stubborn Breakthrough Pain Induced by Swallowing in Patients Receiving Radiotherapy for Nasopharyngeal Carcinoma
Swallowing-induced Pain
Not yet recruitingObservational study
Paediatric Breakthrough Pain Assessment
Breakthrough Pain, Palliative Medicine
RecruitingObservational study
A Real-world Observational Study of a Mucosal Contouring Method for Radiation-induced Oropharyngeal Mucositis
Radiation-induced Oropharyngeal Mucositis, Swallowing-induced Breakthrough Pain
RecruitingObservational study
A Mucosal Contouring Method Based on Swallowing-induced Breakthrough Pain for Radiation-induced Oropharyngeal Mucositis
Radiation-induced Oropharyngeal Mucositis, Swallowing-induced Breakthrough Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director Clinical Science study director
Takeda
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breakthrough Cancer Pain, run by Takeda at 36 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Cancer Participants With Breakthrough Cancer Pain From the Total Number of Cancer Participants Seen in Consultation (time frame: Month 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2019.