NCT03550599

Brief Summary

Aim of the study is to evaluate adequacy of pain treatment in oncologic patients, accessing to Radiotherapy Unit

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 8, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

January 14, 2019

Status Verified

January 1, 2019

Enrollment Period

1 year

First QC Date

May 28, 2018

Last Update Submit

January 11, 2019

Conditions

Cancer PainAnalgesic Drugs

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

patients accessing to Radiotherapy Unit

patients accessing to Radiotherapy Unit for oncologic treatment

Other: Patients accessing to Radiotherapy Unit

Interventions

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

patients accessing to Radiotherapy Unit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

2000 consecutive patients accessing to Radiotherapy Unit

You may qualify if:

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

You may not qualify if:

  • \- Concomitant diseases that can affect reliability of collected data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bologna, BO, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alessio G Morganti, MD

    Radiation Oncology Center, Departement of Experimental, Diagnostic and Speciality Medicine-DIMES, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessio G Morganti, MD

CONTACT

0512143564alessio.morganti2@unibo.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 28, 2018

First Posted

June 8, 2018

Study Start

March 1, 2018

Primary Completion

March 1, 2019

Study Completion

June 1, 2019

Last Updated

January 14, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)