Adequacy of Pain Treatment in Radiotherapy

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

Study Overview

• Status: Unknown
• Conditions: Cancer Pain; Analgesic Drugs
• Intervention / Treatment: Other: 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 Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40138
      • Recruiting
      • Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

2000 consecutive patients accessing to Radiotherapy Unit

Description

Inclusion Criteria:

- patients accessing to Radiotherapy Unit for radiation treatment (both palliative or with radical intent) with diagnosis of primitive or metastatic cancer;

Exclusion Criteria:

- Concomitant diseases that can affect reliability of collected data

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients accessing to Radiotherapy Unit; patients accessing to Radiotherapy Unit for oncologic treatment	Other: Patients accessing to Radiotherapy Unit; No intervention; information about patient and disease characteristics will be recorded as well as information about pain and analgesic treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 months

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Alessio G Morganti, MD, Radiation Oncology Center, Departement of Experimental, Diagnostic and Speciality Medicine-DIMES, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: May 28, 2018
• First Submitted That Met QC Criteria: May 28, 2018
• First Posted (Actual): June 8, 2018

Study Record Updates

• Last Update Posted (Actual): January 14, 2019
• Last Update Submitted That Met QC Criteria: January 11, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain
• Other Study ID Numbers: ARISE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No