Clinical trial NCT03435120: Quality of Life Study Breakthrough Cancer Pain Treated in Medical Oncology Services (CAVIDIOM)
Official title: Quality of Life Study in Patients With Breakthrough Cancer Pain Treated in Medical Oncology Services
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breakthrough Pain
Keywords: Breakthrough Cancer Pain
Quality of life
Medical Oncology
Lead sponsor: Angelini Farmacéutica
Sponsor class: INDUSTRY
Collaborators: name: Apices Soluciones S.L.
First posted: 2018-02-15
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with breakthrough cancer pain treated in Medical Oncology services

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in quality of life of the patients
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Characteristics of patients
timeFrame: At baseline
measure: Characteristics of patients
timeFrame: At baseline
measure: Characteristics of patients
timeFrame: At baseline
measure: Management of cancer breakthrough pain.
timeFrame: Up to 4 weeks
measure: Management of cancer breakthrough pain.
timeFrame: Up to 4 weeks
measure: Anxiety and depression status and the possible relationship between these factors and quality of life.
timeFrame: Up to 4 weeks
measure: Sleep quality and the possible relationship between this factor and quality of life.
timeFrame: Up to 4 weeks
measure: Evaluate caregivers effort
timeFrame: Up to 4 weeks
measure: Perceived assistance quality by patients
timeFrame: Up to 4 weeks
measure: Improvement impression perceived by patients
timeFrame: Up to 4 weeks
measure: Improvement impression perceived by patients
timeFrame: Up to 4 weeks
measure: Improvement impression perceived by patients
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Santiago De Compostela
country: Spain
facility: Complexo Hospitalario Universitario de Santiago
state: A Coruña
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Alcalá De Henares
country: Spain
facility: Hospital Principe de Asturias
state: Madrid
city: Palma De Mallorca
country: Spain
facility: Hospital Universitari Son Espases
state: Palma
city: Reus
country: Spain
facility: Hospital Universitari de San Joan de Reus
state: Tarragona
city: Tortosa
country: Spain
facility: Hospital Verge de la Cinta
state: Tarragona
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcántara
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: Hospital General Universitario de Valencia
name: Carlos Camps Herrero
role: PRINCIPAL_INVESTIGATOR
References: