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

Breakthrough Pain Clinical Trial

— CAVIDIOM  

Official title:

Quality of Life Study in Patients With Breakthrough Cancer Pain Treated in Medical Oncology Services

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03435120
• Other study ID #: ANG-ANA-2017-01 (CAVIDIOM)
• Status: Completed
• Start date: December 21, 2017
• Est. completion date: February 14, 2020

Study information

• Verified date: February 2020
• Source: Angelini Farmacéutica
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: February 14, 2020
• Est. primary completion date: January 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breakthrough Pain
• Cancer Pain

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Spain	Hospital Principe de Asturias	Alcalá De Henares	Madrid
Spain	Hospital San Pedro de Alcántara	Cáceres
Spain	Hospital Arnau de Vilanova	Lleida
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Hospital Universitari Son Espases	Palma De Mallorca	Palma
Spain	Hospital Universitari de San Joan de Reus	Reus	Tarragona
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Complexo Hospitalario Universitario de Santiago	Santiago De Compostela	A Coruña
Spain	Hospital Verge de la Cinta	Tortosa	Tarragona
Spain	Hospital Alvaro Cunqueiro	Vigo
Spain	Hospital Universitario Miguel Servet	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Angelini Farmacéutica	Apices Soluciones S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in quality of life of the patients	Changes according to EQ-5D-5L questionnaire	Up to 4 weeks
Secondary	Characteristics of patients	Kind of tumor.	At baseline
Secondary	Characteristics of patients	Demographic data	At baseline
Secondary	Characteristics of patients	ECOG	At baseline
Secondary	Management of cancer breakthrough pain.	Cancer breakthrough pain characteristics (time until maximum intensity)	Up to 4 weeks
Secondary	Management of cancer breakthrough pain.	Cancer breakthrough pain evolution (duration and management)	Up to 4 weeks
Secondary	Anxiety and depression status and the possible relationship between these factors and quality of life.	Goldberg Anxiety and Depression Scale.	Up to 4 weeks
Secondary	Sleep quality and the possible relationship between this factor and quality of life.	MOS sleep questionnaire	Up to 4 weeks
Secondary	Evaluate caregivers effort	Results according to caregivers effort Index	Up to 4 weeks
Secondary	Perceived assistance quality by patients	Results according to Sociofamily evaluation scale of "Gijon"	Up to 4 weeks
Secondary	Improvement impression perceived by patients	Results according to assessment of perceived quality (questionnaire of the Ministry of Health and Consumer Affairs)	Up to 4 weeks
Secondary	Improvement impression perceived by patients	Results according to Satisfaction questionnaire PGI-I	Up to 4 weeks
Secondary	Improvement impression perceived by patients	Results according to Satisfaction questionnaire CGI-I	Up to 4 weeks