Cancer PainNCT03550599
Adequacy of Pain Treatment in Radiotherapy
An observational study of Cancer Pain and Analgesic Drugs, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Aim of the study is to evaluate adequacy of pain treatment in oncologic patients, accessing to Radiotherapy Unit Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Pain, Analgesic Drugs
- What is being tested?
- Patients accessing to Radiotherapy Unit
- How many people
- 2,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2018to 1 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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: 2000 consecutive patients accessing to Radiotherapy Unit
Who may be able to join
- patients accessing to Radiotherapy Unit for radiation treatment (both palliative or with radical intent) with diagnosis of primitive or metastatic cancer;
Who cannot join
- Concomitant diseases that can affect reliability of collected data
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital
Bologna, BO, 40138
Alessio G Morganti, MD, 0512143564 ext. +39, alessio.morganti2@unibo.it
About this study
Official title: Adequacy of Pain Treatment in Radiotherapy: an Observational, Prospective, Multicenter Study (ARISE)
Aim of the study is to evaluate adequacy of pain treatment in oncologic patients, accessing to Radiotherapy Unit
Read the detailed description
Prescription of analgesic drugs is a basic topic in cancer patients, but undertreatment is common. The aim of the study is to analyse pain control and adequacy of antalgic treatments in patients coming to Radiotherapy Unit for radiation treatment.
- Conditions
- Cancer Pain, Analgesic Drugs
- Being tested
- Patients accessing to Radiotherapy Unit
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients accessing to Radiotherapy UnitOther
No intervention; information about patient and disease characteristics will be recorded as well as information about pain and analgesic treatment
| Study group | Role | What they receive |
|---|---|---|
| patients accessing to Radiotherapy Unit | patients accessing to Radiotherapy Unit for oncologic treatment Receives: Other: Patients accessing to Radiotherapy Unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of adequacy of pain treatment
For all patients, Visual Analogue Scale (VAS) and information about type of analgesic drugs (no drugs; non-opioid drugs; weak opioids; strong opioids) will be recorded and analysed
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start1 Mar 2018
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- 2,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessio Giuseppe Morganti, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Alessio G Morganti, MD, Principal investigator, Radiation Oncology Center, Departement of Experimental, Diagnostic and Speciality Medicine-DIMES, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550599
- Sponsor's protocol ID
- ARISE
- Status last verified
- Jan 2019
- First submitted
- 28 May 2018
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adequacy of Pain Treatment in Radiotherapy: an Observational, Prospective, Multicenter Study (ARISE)
- ClinicalTrials.gov ID
- NCT03550599
- Acronym / sponsor ID
- ARISE
- Conditions
- Cancer Pain, Analgesic Drugs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 8 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the study is to evaluate adequacy of pain treatment in oncologic patients, accessing to Radiotherapy Unit
Detailed description
Prescription of analgesic drugs is a basic topic in cancer patients, but undertreatment is common. The aim of the study is to analyse pain control and adequacy of antalgic treatments in patients coming to Radiotherapy Unit for radiation treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients accessing to Radiotherapy Unit | – | Other: Patients accessing to Radiotherapy Unitpatients accessing to Radiotherapy Unit for oncologic treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 2000 consecutive patients accessing to Radiotherapy Unit
Key inclusion criteria (1 listed)
- patients accessing to Radiotherapy Unit for radiation treatment (both palliative or with radical intent) with diagnosis of primitive or metastatic cancer;
Key exclusion criteria (1 listed)
- Concomitant diseases that can affect reliability of collected data
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 |
|---|---|---|
| Patients accessing to Radiotherapy UnitNo intervention; information about patient and disease characteristics will be recorded as well as information about pain and analgesic treatment | Other | patients accessing to Radiotherapy Unit |
Primary outcome
Evaluation of adequacy of pain treatment
Time frame: 2 months
For all patients, Visual Analogue Scale (VAS) and information about type of analgesic drugs (no drugs; non-opioid drugs; weak opioids; strong opioids) will be recorded and analysed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Alessio G Morganti, MD principal investigator
Radiation Oncology Center, Departement of Experimental, Diagnostic and Speciality Medicine-DIMES, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Pain and Analgesic Drugs, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessio G Morganti, MD (0512143564 ext. +39, alessio.morganti2@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of adequacy of pain treatment (time frame: 2 months). 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 14 Jan 2019.