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

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

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.

Study Overview

• Status: Completed
• Conditions: Breakthrough Pain
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 118

Contacts and Locations

Study Locations

• Spain
  • Cáceres, Spain, 10002
    • Hospital San Pedro de Alcantara
  • Lleida, Spain, 25198
    • Hospital Arnau de Vilanova
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28034
    • Hospital Ramón y Cajal
  • Madrid, Spain, 28023
    • Hospital Universitario La Paz
  • Salamanca, Spain, 37007
    • Hospital Universitario de Salamanca
  • Vigo, Spain
    • Hospital Álvaro Cunqueiro
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet
  • A Coruña
    • Santiago De Compostela, A Coruña, Spain, 15706
      • Complexo Hospitalario Universitario De Santiago
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Hospital Universitario Central de Asturias
  • Madrid
    • Alcalá De Henares, Madrid, Spain
      • Hospital Principe de Asturias
  • Palma
    • Palma De Mallorca, Palma, Spain
      • Hospital Universitari Son Espases
  • Tarragona
    • Reus, Tarragona, Spain, 43204
      • Hospital Universitari de San Joan de Reus
    • Tortosa, Tarragona, Spain, 43500
      • Hospital Verge de la Cinta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with breakthrough cancer pain treated in Medical Oncology services

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Breakthrough Cancer Pain; No intervention (Non Interventional Study)	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in quality of life of the patients	Changes according to EQ-5D-5L questionnaire	Up to 4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Angelini Farmacéutica
• Collaborators: Apices Soluciones S.L.
• Investigators: Principal Investigator: Carlos Camps Herrero, Hospital General Universitario de Valencia

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2017
• Primary Completion (Actual): January 24, 2020
• Study Completion (Actual): February 14, 2020

Study Registration Dates

• First Submitted: January 29, 2018
• First Submitted That Met QC Criteria: February 14, 2018
• First Posted (Actual): February 15, 2018

Study Record Updates

• Last Update Posted (Actual): March 2, 2020
• Last Update Submitted That Met QC Criteria: February 28, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Quality of life; Breakthrough Cancer Pain; Medical Oncology
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Breakthrough Pain; Cancer Pain
• Other Study ID Numbers: ANG-ANA-2017-01 (CAVIDIOM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No