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

February 28, 2020 updated by: Angelini Farmacéutica

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
118

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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 Ramon y Cajal
      • Madrid, Spain, 28023
        • Hospital Universitario La Paz
      • Salamanca, Spain, 37007
        • Hospital Universitario De Salamanca
      • Vigo, Spain
        • Hospital Alvaro 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 Príncipe 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Breakthrough Cancer Pain
No intervention (Non Interventional Study)
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in quality of life of the patients
Time Frame: Up to 4 weeks
Changes according to EQ-5D-5L questionnaire
Up to 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Characteristics of patients
Time Frame: At baseline
Kind of tumor.
At baseline
Characteristics of patients
Time Frame: At baseline
Demographic data
At baseline
Characteristics of patients
Time Frame: At baseline
ECOG
At baseline
Management of cancer breakthrough pain.
Time Frame: Up to 4 weeks
Cancer breakthrough pain characteristics (time until maximum intensity)
Up to 4 weeks
Management of cancer breakthrough pain.
Time Frame: Up to 4 weeks
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.
Time Frame: Up to 4 weeks
Goldberg Anxiety and Depression Scale.
Up to 4 weeks
Sleep quality and the possible relationship between this factor and quality of life.
Time Frame: Up to 4 weeks
MOS sleep questionnaire
Up to 4 weeks
Evaluate caregivers effort
Time Frame: Up to 4 weeks
Results according to caregivers effort Index
Up to 4 weeks
Perceived assistance quality by patients
Time Frame: Up to 4 weeks
Results according to Sociofamily evaluation scale of "Gijon"
Up to 4 weeks
Improvement impression perceived by patients
Time Frame: Up to 4 weeks
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
Time Frame: Up to 4 weeks
Results according to Satisfaction questionnaire PGI-I
Up to 4 weeks
Improvement impression perceived by patients
Time Frame: Up to 4 weeks
Results according to Satisfaction questionnaire CGI-I
Up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Angelini Farmacéutica

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Apices Soluciones S.L.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carlos Camps Herrero, Hospital General Universitario de Valencia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 21, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 24, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 14, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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