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| ID | Type | Description | Link |
|---|---|---|---|
| CARPEDIO Study | Other Identifier | Other |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Participants with cancer pain that is adequately controlled with opioids were observed for a period of 1 month in this observational study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with cancer pain will be included in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Universitario de Elda-Virgen de La Salud | Elda | Alicante | 3600 | Spain | ||
| Hospital Universitario San Juan de Alicante |
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.
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Participants with a diagnosis of cancer pain were enrolled and observed to characterize the participants with breakthrough pain.
Participants took part in the study at 32 investigative sites in Spain from 14 November 2016 to 16 July 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Participants with cancer pain that is adequately controlled with opioids were observed for a period of 1 month in this observational study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 19, 2016 | Jul 11, 2019 |
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| 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 |
| San Juan |
| Alicante |
| 3550 |
| Spain |
| Hospital Universitari Son Espases | Palma de Mallorca | Balearic Islands | 7120 | Spain |
| Hospital Son Llatzer | Palma de Mallorca | Balearic Islands | 7198 | Spain |
| Hospital Universitari Germans Trias I Pujol de Badalona | Badalona | Barcelona | 08916 | Spain |
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 8907 | Spain |
| Hospital de Especialidades de Puerto Real | Puerto Real | Cadiz | 11510 | Spain |
| Hospital Universitario de Gran Canaria Dr. Negrin | Las Palmas de Gran Canaria | Canary Islands | 35010 | Spain |
| Complejo Hospitalario Universitario Insular-Materno Infantil | Las Palmas de Gran Canarias | Canary Islands | 35001 | Spain |
| Hospital Universitario Nuestra Senora de Candelaria | Santa Cruz de Tenerife | Canary Islands | 38010 | Spain |
| Hospital de Alta Resolucion de Guadix | Guadix | Granada | 18500 | Spain |
| Hospital Universitario Principe de Asturias | Alcalá de Henares | Madrid | 28805 | Spain |
| Hospital Universitario Puerta de Hierro, Majadahonda | Majadahonda | Madrid | 28222 | Spain |
| Hospital Quiron Madrid | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Complejo Hospital Costa Del Sol | Marbella | Malaga | 29603 | Spain |
| Hospital General Universitario Santa Lucia | Cartagena | Murcia | 30202 | Spain |
| Clinica Universidad de Navarra | Pamplona | Navarre | 31008. | Spain |
| Hospital Los Montalvos | Carrascal de Barregas | Salamanca | 37197 | Spain |
| Complexo Hospitalario Universitario A Coruna | A Coruña | 15006 | Spain |
| Centro Oncoloxico de Galicia | A Coruña | 15009 | Spain |
| Hospital Torrecardenas | Almería | 4009 | Spain |
| Hospital Puerta Del Mar | Cadiz | 11009 | Spain |
| Hospital Reina Sofia | Córdoba | 14004 | Spain |
| Hospital Universitario Virgen de Las Nieves | Granada | 18014 | Spain |
| Complejo Hospitalario de Jaen | Jaén | 23007 | Spain |
| Hospital Universitario de La Princesa | Madrid | 28006 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Complejo Hospitalario Regional de Malaga | Málaga | 29010 | Spain |
| Hospital Virgen de La Victoria | Málaga | 29010 | Spain |
| Hospital Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital Nuestra Senora de Valme | Seville | 41014 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| Hospital Universitario Doctor Peset | Valencia | 46017 | Spain |
| COMPLETED |
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| NOT COMPLETED |
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All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Participants with cancer pain that is adequately controlled with opioids were observed for a period of 1 month in this observational study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Number analyzed is the number of participants with data available for this baseline measure. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Number analyzed is the number of participants with data available for this baseline measure. | Count of Participants | Participants |
| |||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Prevalence Study Population included participants with the prevalence of breakthrough cancer pain for whom data was collected in prevalence form in the database. | Posted | Number | 95% Confidence Interval | percentage of participants | 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. | Participants with cancer pain from the Prevalence Study Population, participants with the prevalence of breakthrough cancer pain for whom data was collected in prevalence form in the database. | Posted | Number | 95% Confidence Interval | percentage of participants | 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. | Prevalence Study Population included participants with the prevalence of breakthrough cancer pain for whom data was collected in prevalence form in the database. Number analyzed is the total number of participants with data available for the time of diagnosis of breakthrough cancer pain. | Posted | Count of Participants | Participants | 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. | Participants with cancer pain from the Prevalence Study Population, participants with the prevalence of breakthrough cancer pain for whom data was collected in prevalence form in the database, with data available for the time of diagnosis of breakthrough cancer pain. | Posted | Number | 95% Confidence Interval | percentage of participants | 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. | Participants from Prevalence Study Population, participants with the prevalence of breakthrough cancer pain for whom data was collected in prevalence form in the database with breakthrough cancer pain who did not take any treatment for it and who administered the scale. Number analyzed is the participants with data available for the given question. | Posted | Number | percenatge of participants | 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. | Participants from Prevalence Study Population, participants with the prevalence of breakthrough cancer pain for whom data was collected in prevalence form in the database with breakthrough cancer pain who did not take any treatment for it and who administered the scale. Number analyzed is the participants with data available for the given category. | Posted | Mean | Standard Deviation | score on a scale | Month 1 |
|
| ||||||||||||||||||||||||||
| Secondary | Pain Assessment Using the Numeric Rating Scale | Data was not collected for this outcome measure. | Posted | 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). | Participants from Prevalence Study Population, participants with the prevalence of breakthrough cancer pain for whom data was collected in prevalence form in the database with breakthrough cancer pain who did not take any treatment for it and who administered the scale with data available for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | 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'. | Prevalence Study Population included participants with the prevalence of breakthrough cancer pain for whom data was collected in prevalence form in the database with data available for this outcome measure. | Posted | Number | percentage of participants | Month 1 |
|
|
Baseline up to Month 1
Data of adverse events or adverse drug reactions were not collected as part of the study database.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | Participants with cancer pain that is adequately controlled with opioids were observed for a period of 1 month in this observational study. | 0 | 0 | 0 | 0 | 0 | 0 |
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The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 24, 2017 | Jul 11, 2019 | SAP_001.pdf |
| Male |
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| Participants |
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