CompletedNot Applicable

Characterisation and Epidemiology of Breakthrough Cancer Pain in Spain

Spain3,765 participantsStarted 2016-11-14

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Cancer Participants With Breakthrough Cancer Pain From the Total Number of Cancer Participants Seen in Consultation

Timeframe: Month 1

Percentage of Cancer Participants With Breakthrough Cancer Pain From the Number of Cancer Participants With Pain Seen in Consultation

Timeframe: Month 1

Trial details

NCT IDNCT02899884

SponsorTakeda

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-04-04

Results submitted2019-07-11

View on ClinicalTrials.gov More Breakthrough Cancer Pain trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Percentage of Cancer Participants With Breakthrough Cancer Pain From the Total Number of Cancer Participants Seen in Consultation

Timeframe: Month 1

Percentage of Cancer Participants With Breakthrough Cancer Pain From the Number of Cancer Participants With Pain Seen in Consultation

Timeframe: Month 1