Quality of Life Study Breakthrough Cancer Pain Treated in Medical Oncology Services (CAVIDIOM)

NCT ID: NCT03435120

Last Updated: 2020-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

118 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-21

Study Completion Date

2020-02-14

Brief Summary

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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.

Detailed Description

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Conditions

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Breakthrough Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Breakthrough Cancer Pain

No intervention (Non Interventional Study)

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Apices Soluciones S.L.

INDUSTRY

Sponsor Role collaborator

Angelini Farmacéutica

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carlos Camps Herrero

Role: PRINCIPAL_INVESTIGATOR

Hospital General Universitario de Valencia

Locations

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Complexo Hospitalario Universitario de Santiago

Santiago de Compostela, A Coruña, Spain

Site Status

Hospital Principe de Asturias

Alcalá de Henares, Madrid, Spain

Site Status

Hospital Universitari Son Espases

Palma de Mallorca, Palma, Spain

Site Status

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Site Status

Hospital Universitari de San Joan de Reus

Reus, Tarragona, Spain

Site Status

Hospital Verge de la Cinta

Tortosa, Tarragona, Spain

Site Status

Hospital San Pedro de Alcántara

Cáceres, , Spain

Site Status

Hospital Arnau de Vilanova

Lleida, , Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

Hospital Ramón y Cajal

Madrid, , Spain

Site Status

Hospital Clínico San Carlos

Madrid, , Spain

Site Status

Hospital Universitario de Salamanca

Salamanca, , Spain

Site Status

Hospital Alvaro Cunqueiro

Vigo, , Spain

Site Status

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Site Status

Countries

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Spain

Other Identifiers

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ANG-ANA-2017-01 (CAVIDIOM)

Identifier Type: -

Identifier Source: org_study_id

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