NCT03435120

Brief Summary

In cancer patients, pain is one of the most common symptoms. The range of reported prevalence of pain varies from 33% to 64% including different stages of cancer, during or after anticancer treatment. Moreover, despite the optimal management of basal chronic pain, 66% of these patients have reported breakthrough pain which has a severe impact on quality of life. There is insufficient clinical information on the quality of life of cancer patients with breakthrough pain treated in medical oncology services according to routine clinical practice. For this reason we consider it is appropriate to prospectively evaluate the quality of life of cancer patients with cancer breakthrough pain in medical oncology services as well as other factors that can affect quality of life. This post-authorization observational study will assess the quality of life of cancer patients with breakthrough cancer pain treated in medical oncology services in Spanish hospitals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

Typical duration for all trials

Geographic Reach
1 country

14 active sites

Status
completed

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

December 21, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 29, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 15, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2020

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2020

Completed
Last Updated

March 2, 2020

Status Verified

February 1, 2020

Enrollment Period

2.1 years

First QC Date

January 29, 2018

Last Update Submit

February 28, 2020

Conditions

Breakthrough Pain

Keywords

Breakthrough Cancer PainQuality of lifeMedical Oncology

Outcome Measures

Primary Outcomes (1)

  • Changes in quality of life of the patients

    Changes according to EQ-5D-5L questionnaire

    Up to 4 weeks

Secondary Outcomes (12)

  • Characteristics of patients

    At baseline

  • Characteristics of patients

    At baseline

  • Characteristics of patients

    At baseline

  • Management of cancer breakthrough pain.

    Up to 4 weeks

  • Management of cancer breakthrough pain.

    Up to 4 weeks

  • +7 more secondary outcomes

Study Arms (1)

Breakthrough Cancer Pain

No intervention (Non Interventional Study)

Other: No intervention

Interventions

No interventionOTHER

No intervention

Breakthrough Cancer Pain

Eligibility Criteria

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

Patients with breakthrough cancer pain treated in Medical Oncology services

You may qualify if:

  • Patients \> 18 years
  • Patients with histologically confirmed neoplasia
  • Patients attended in medical oncology consultations
  • Life expectancy \> 3 months
  • Patients with baseline controlled cancer pain with opioids who are diagnosed of breakthrough cancer pain by Davies algorithm
  • Written informed consent

You may not qualify if:

  • Untreated patients with opioids for baseline pain
  • Patients who are not opioid tolerant
  • Serious psychiatric disorder or any disease or condition that prevents the collection of data
  • Patients with evidence of opioid addiction or history of drug or alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Complexo Hospitalario Universitario de Santiago

Santiago de Compostela, A Coruña, 15706, Spain

Location

Hospital Principe de Asturias

Alcalá de Henares, Madrid, Spain

Location

Hospital Universitari Son Espases

Palma de Mallorca, Palma, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

Location

Hospital Universitari de San Joan de Reus

Reus, Tarragona, 43204, Spain

Location

Hospital Verge de la Cinta

Tortosa, Tarragona, 43500, Spain

Location

Hospital San Pedro de Alcántara

Cáceres, 10002, Spain

Location

Hospital Arnau de Vilanova

Lleida, 25198, Spain

Location

Hospital Universitario La Paz

Madrid, 28023, Spain

Location

Hospital Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Alvaro Cunqueiro

Vigo, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Breakthrough Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Carlos Camps Herrero

    Hospital General Universitario de Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2018

First Posted

February 15, 2018

Study Start

December 21, 2017

Primary Completion

January 24, 2020

Study Completion

February 14, 2020

Last Updated

March 2, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(14)