Characterisation and Epidemiology of Breakthrough Cancer Pain in Spain
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| ClinicalTrials.gov Identifier: NCT02899884 |
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Recruitment Status :
Completed
First Posted : September 14, 2016
Results First Posted : November 22, 2019
Last Update Posted : November 22, 2019
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Sponsor:
Takeda
Information provided by (Responsible Party):
Takeda
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Breakthrough Cancer Pain | Other: No Intervention |
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 |
| Actual Enrollment : | 3765 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Characterisation and Epidemiology of Breakthrough Cancer Pain in Spain |
| Actual Study Start Date : | November 14, 2016 |
| Actual Primary Completion Date : | April 4, 2018 |
| Actual Study Completion Date : | July 16, 2018 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Cohort 1
Participants with cancer pain that is adequately controlled with opioids were observed for a period of 1 month in this observational study.
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Other: No Intervention |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- Number of New Participants Diagnosed With Breakthrough Cancer Pain From the Total Number of Cancer Participants Seen in Consultation [ Time Frame: 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.
- Percentage of New Participants Diagnosed With Breakthrough Cancer Pain From the Number of Cancer Participants With Pain Seen in Consultation [ Time Frame: 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 Characterization With the Alberta Breakthrough Pain Assessment [ Time Frame: 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.
- Pain Severity and Pain Interference as Assessed by Brief Pain Inventory (BPI) Questionnaire Score [ Time Frame: 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.
- 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 ]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 [ Time Frame: 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'.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Participants with cancer pain will be included in the study.
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02899884
Locations
Show 36 study locations
Sponsors and Collaborators
Takeda
Investigators
| Study Director: | Medical Director Clinical Science | Takeda |
Study Documents (Full-Text)
Documents provided by Takeda:
Documents provided by Takeda:
Study Protocol [PDF] February 19, 2016
Statistical Analysis Plan [PDF] January 24, 2017
| Responsible Party: | Takeda |
| ClinicalTrials.gov Identifier: | NCT02899884 |
| Other Study ID Numbers: |
Fentanyl-5001 CARPEDIO Study ( Other Identifier: Other ) |
| First Posted: | September 14, 2016 Key Record Dates |
| Results First Posted: | November 22, 2019 |
| Last Update Posted: | November 22, 2019 |
| Last Verified: | November 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Takeda:
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Drug Therapy |
Additional relevant MeSH terms:
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Cancer Pain Pain Neurologic Manifestations |